Fall 2021 Clinical Research as a Care Option Newsletter

Fall 2021 Newsletter

Getting Healthcare Providers Involved in Clinical Research

CRAACO Clinical Research as a Care Option

Dr Charlotte Grayson

First Georgia Physician Group

Dr Suzanne Rose

Stamford Hospital

Christa Braun-Ingles

University of Hawai’i Cancer

Center

Dr Suzanne Steinbaum

SRSHeart

Dr Narayanachar Murali

Gastroenterology Associates of

Orangeburg South Carolina

Fall 2021 Clinical Research as a Care Option Newsletter

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upcoming eventsDPHARM: Disruptive Innovations to Advance Clinical ResearchSeptember 28-29, 2021 Click for information

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Welcome to the Fall 2021 issue of the Clinical Research as a Care Option (CRAACO) newsletter, which highlights physician-investigators and their partners who are doing the work to bring care and research together for the best patient treatment. In this issue:

Charlotte Grayson, MD, of First Georgia Physician Group, describes her experience as a new physician-investigator, including onboarding her staff and discussing trials with patients.

Christa Braun-Ingles, MS, APRN, of University of Hawai’i Cancer Center, discusses the valuable role Advanced Practice Providers can play in easing the burden facing community practices who would like to participate in clinical research.

Suzanne Rose, MS, PhD, describes the compensation model she created to fairly and transparently pay physicians for conducting research, and the impacts it has had in her hospital.

Narayanachar Murali, MD, of Gastroenterology Associates of Orangeburg South Carolina, gives his experience as a solo physician, offering clinical trials to his patients and navigating the increasing workload of clinical research.

Suzanne Steinbaum, DO, of SRSHeart, speaks to the communication required – between doctor and patient, doctor and institution, and doctor and trial – that would make trials a more appealing option for physicians to offer to patients.

And finally, we end with coverage of a conversation between Dr Janet Woodcock, acting FDA commissioner, and Dr Laura Esserman, UCSF Carol Franc Buck Breast Cancer Center, in which they discuss the dire need for community sites to be capable of clinical research, and how care and research can begin to resemble each other.

The CRAACO newsletter is the official publication of the Clinical Research as a Care Option conference. Enjoy the Fall 2021 issue.

Welcome Letter

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Fall 2021 Clinical Research as a Care Option Newsletter

Inside the IssueCharlotte Grayson, MD, Partner, Internist, First Georgia Physician Group

Christa Braun-Ingles, MS, APRN, Assistant Researcher, University of Hawai’i Cancer Center

Suzanne Rose, MS, PhD, Director, Office of Research, Stamford Hospital

Narayanachar Murali, Gastroenterology Specialist, Gastroenterology Associates of Orangeburg South Carolina

Suzanne Steinbaum, DO, Cardiologist, President, SRSHeart

From the Archives: Dr Janet Woodcock, acting FDA commissioner, and Dr Laura Esserman, UCSF Carol Franc Buck Breast Cancer Center

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Recommended MediaClick below for media that furthers the conversation of clinical care integrating with clinical research.

podcastOvercoming Site Regulatory Issues to Optimize Clinical Quality

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podcastInsights from CRAACO 2020 and Looking to the Future

newsletterClinical Research as a CareOption newsletter “Health IT &Data Sharing” issue

recapFull recap of the 2021Clinical Research as a CareOption event

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Fall 2021 Clinical Research as a Care Option Newsletter

September 28-29, 2021

March 14-15, 2022January 24-25, 2022

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Patients as Partners Europe

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Clinical Research as a Care Option

Fall 2021 Clinical Research as a Care Option Newsletter

Charlotte Grayson, MD, is Partner and Internist at First Georgia Physician Group, practicing internal medicine in Fayetteville, Georgia. Dr Grayson is interested in women’s health, preventive medicine, geriatrics, and hospice/palliative care.

As a physician, how did you first come into contact with clinical research?

I am an internal medicine physician. I ended up training at the Medical University of South Carolina, in Charleston. I initially went into practice for a short amount of time, before being asked to help launch what is now known as WebMD. I was asked to be one of their founding physicians. I worked with them for seven or eight years. During that time, I went to medical conferences where I learned a lot about clinical research. I was learning to distill medical research for consumers and for physicians. I eventually went back into practice and ended up where I am now in Fayette County, seeing patients in a private practice in internal medicine.

When did clinical research become something you wanted to pursue for your practice?

Clinical research in private practice wasn’t something that was really available for the majority of the time that I’ve been in practice. Usually, research was done in the big medical centers like Emory. So once we joined with Privia Health and we took our practice private again, that’s when the opportunities came through Javara, to allow us to bring research into the community. I thought it was a really exciting possibility for my patients to get the chance to try cutting-edge medicine.

What was the first experience in research like?

I knew a little bit about research, but it was really like learning another language. I did some online training classes, but there’s a lot of acronyms in clinical research. The language of research is very different from the language of medicine. It was a lot like going back to school. Some of it was familiar, such as informed consent, but the amount of data, and the way that it was presented to me and how I would have to present research to patients, was quite different from what I was used to. My first reaction when I first was presented with a trial was excitement.

I was able to look at some information about an interesting treatment that was coming out. I was able to look at data that I normally don’t get the opportunity to see in practice. And I could immediately envision the kind of patient that would really benefit from this opportunity. And so I was excited when I first heard about it, but it was definitely a learning curve to understand the moving pieces.

What were some of the unexpected parts of participating in clinical research?

Some of it was just the language. The language was very different from how I normally think about things day-to-day. The technology was a little bit difficult: I’m a physician in my 50s, so I came along at a point where we didn’t have computers until I was out of medical school. So being able to figure out how to access all of this information and how to use it when it was online was a challenge. And every research study we’ve gotten involved with uses totally different platforms, so I was having to learn not just one platform, but three, four, sometimes five. All different platforms, with different passwords and ways to access and find information. On the patient side, I had two different types of experiences. I have those patients who, the minute I mentioned a research trial, were interested. They wanted to do everything that you offered to them; they didn’t have any questions. But then I had patients where I had to pull out my skills and my relationships with them to communicate the benefits and advantages. The minute you mentioned research, they felt like they would be experimented on. But I learned a lot from how to approach patients in the best way.

How do you prepare your staff for clinical research?

There are about 15 different providers in my practice. It was really important to me, especially with these trials, that not only was I opening up the studies for my patients, but that my partners’ patients had access too.

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A New Physician-Investigator On Bringing Research to Patients

Fall 2021 Clinical Research as a Care Option Newsletter

Even if you have the ideal population, you don’t have the experience and I think a lot of drug companies or manufacturers really are looking for those experienced clinical trial folks. The best way for someone to get involved would be to talk to other doctors. Make contacts with other people who actually do clinical research so that they can make inroads with either drug companies or other groups that can help them start their own research programs. You can also partner with a research organization who can provide the infrastructure and staff to support you with training, recruiting patients, and conducting the trials.

If you could change one thing instantly, what would it be to make trials more convenient for providers to participate?

At the top would the technology: the amount of platforms, the number of different systems that are needed for a trial. I’m sure that there is a purpose for all of it, but I’ve found that to be difficult. Right now, I’m in the process of working on about seven clinical trials, and I had to get access to and learn about 15 different systems. Every clinical trial does something completely different. I had to spend a whole afternoon just making files to try to figure out what goes with which clinical trial. It would be nice if, in a company, you go to one play, and make your link. And they put anything that you can do that, right. Something that would be really great would be to reach out to medical practices. Some of them are smaller, and they’re not university centers, but get them involved in clinical research, even if they can only offer small numbers of patients for studies. It’s important to reach outside of urban center communities, and to get patients involved in studies who normally and historically have never been involved in clinical trials. And really, the only way you’re going to get some of these populations and trials is to go outside of the comfort zone, and to work with doctors and communities, and help us educate patients on the benefits of trials so that they can have trials that are more representative of the population.

What is your final message on your experience in clinical research thus far?

The past year and a half that I’ve been doing clinical research has been a great experience for me. I have really enjoyed learning the process, but more importantly, it’s been really exciting to interact with my patients in a different way. I’ve learned to listen to them in a different way, to understand more of what it is that they don’t understand about clinical trials. It’s forced me to reach out a little bit more to patients and communities, and to communicate with people differently. It’s been great to bring research into my practice. I think that my patients will benefit from the technology that’s coming our way.

It was easy to educate my partners, but a lot of our patients’ first access to our practice is through the nursing staff or through the administrative staff. And in some of the studies, especially one of the early ones I did with COVID-19, I needed to identify patients almost before the doctor saw them. So I ended up having to create ways to explain clinical trials to my administrative and nursing staff. I would sit down with them to explain the criteria of the study and what to look for. I would tell them how to explain the studies to patients. With one trial, we were trying to do outreach in the community. I had to develop information that we could put out on social media.

I’ve had to do a lot of one-on-one education to try to get some of the information out. I found that the personal touch worked better. It was probably slower than just sending out emails, but I felt that people understood much better when I actually sat down with them and explained it to them.

I have a large minority population in my practice where some are skeptical about clinical research. However, I also have a subset of my minority patients who’ve said, “This is exactly why I came to you, and why I tell all of my friends to come to you, because you are on top of the latest thing, and I want to be offered the newest therapy.” They wanted to have access to some of these technologies that they couldn’t get in Fayette County. And then of course, I have the whole other subset of patients where I have to explain what a clinical trial is, what a placebo is, what informed consent is and explain the different phases. Helping them understand what they’re getting into requires a good bit of education.

Have you had conversations with external providers about research?

I have, especially in my local community, where with some of these bigger trials, I’m trying to recruit patients who are outside of our practice. I have a lot of one-on-one conversations with some of the specialists in our area, to encourage their patients to contact us for trials. They’re all really excited about it. We live in an area that’s not in the city of Atlanta, so the opportunities for their patients to get some of these cutting-edge technologies is very limited. The overall response has been very positive and very supportive.

What do you see as some of the common hurdles that prevent providers from bringing research as a care option to their patients?

The biggest one is our time limitations. Our practices are extremely busy. You are working full time just to see patients. And so I think the idea of actually bringing in clinical research is daunting. There is a lot of information involved. There’s an expertise involved in running a clinical trial that most private practices aren’t going to be able to do. Most people who work in private practice don’t know how to manage a clinical trial. And then of course, most clinical research is usually in centers and facilities that do clinical research; so breaking into it is also really hard.

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I have a subset of my patients who’ve said, “This is exactly why I came to you.”

Fall 2021 Clinical Research as a Care Option Newsletter

Christa Braun-Ingles, MS, APRN, is Assistant Researcher at the University of Hawai’i Cancer Center and Clinical Faculty at the University of Hawai’i School of Nursing and Dental Hygiene. She has a passion for empowering advanced practice providers (APPs) to take a more active role in clinical research.

Can you describe your work and what sparked your passion for research?

I’m an oncology nurse practitioner, and I’ve been practicing for 18 years. I became involved in research about five years into my career, working with a physician who really thought about us working as a team putting patients on clinical trials. It was a community oncology practice, because we were part of an NCORP.

We worked in a busy community practice. He was really interested in putting patients on trial. He said, “I’ll introduce the trial, and then when you sit down to talk to the patients about their chemotherapy, you’re going to talk more about the trial.”

We worked really well at getting patients enrolled on trials in that way. He noted that there were symptom management, cancer control trials and other trials, where I was already doing that work, so he suggested I should be reviewing these trials to make recommendations on whether or not we should open them.It was two-pronged in that way: he got me really engaged in clinical research both from a treatment perspective and from a quality-of-life cancer control and symptom management perspective.

Advanced practice providers do a lot of the clinical care; maybe the oncologist makes a choice in treatment, but we really provide that continuity and ongoing treatment management. And so, we have become experts in symptom management. We as APPs can follow patients on treatment trials easily, because there’s a protocol in front of us, and we can follow that protocol. And then in addition, we can really identify patients for other types of trials.

What are the concerns you think providers have about participating in research?

I come across the perception that it’s a lot of work. In both treatment trials and symptom management trials, I get “Why would we want to do that?

Because I have to do X, Y and Z.” But my argument back is that there are many reasons that we want to do research.

The obvious, glaring reason is that this is how we get standards-of-care. The standards-of-care today were clinical research in the past. We need to continue to provide clinical research to improve those standards.

In addition, what’s so important for us here in Hawai’i is that we have a very unique racial and ethnic background and such rich data here for our patients to participate in research. And if they do not, then we don’t have a voice.

We know that we can’t give certain medications at certain doses, because this type of patient won’t respond well. But what if that type of patient wasn’t accounted for in trials? If we had more participation from these different groups in the trials, then we would know what differences we might actually see.

It obviously is about the cutting-edge in many ways, but also how can we move science forward if we don’t participate?

And the other thing, too, is that for us to participate in research in the community is extremely important. Even though I am part of the University of Hawai’i Cancer Center, because of our landscape in Hawai’i, we don’t have clinical space at the University of Hawai’i. We don’t have a hospital; we don’t have an outpatient clinic. So all of our practice is done in the community.

What are the conversations you have with patients about participating in research?

For the most part, if you take the time to talk to patients about the research, there is data showing that half of patients will enroll in a clinical trial if it’s offered to them. And I believe that’s true. Part of the problem is that we’re not educating them enough about clinical research options.

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Conducting Clinical Research in the Community, A Dual Perspective on Gaps and Opportunities

Fall 2021 Clinical Research as a Care Option Newsletter

I said, “I’m interested in it and I’ll serve as the PI.” But however, just because I’m interested doesn’t mean I’m sure we should open it. I need buy-in from other people.

We need to know what the workflow will be in order to identify patients for this trial, because there would be a lot of resources that are going into this insomnia trial. I’m not saying that it’s not important and perhaps it’s important to patients and I haven’t asked them about it yet. That’s also another reason why it’s important to clinical research: we learn so much. You might say, “That’s not an issue for my patient population,” and then you start asking patients and realize that it is. Sometimes we’re not asking the right questions.

Where do you see the gaps in the journey towards marrying research and care for the benefit of patients?

There’s a couple things. I think we do have to think more about pragmatic trials. I respect the fidelity of the data, but when I review a trial, I do see multiple objectives. Sometimes they’re just exploratory objectives or secondary objectives, but all of that adds on more of a workload. Perhaps they could be optional versus mandatory. We have to make sure that the data is good and keep integrity at the center, but think outside of the box on some of the other aspects. Let’s really pick the most pertinent objectives and maybe have two instead of having five, and then three more exploratory objectives.

You can collect all this data, but do you need to? Because that would make it less burdensome on the sites. I appreciate the researchers, but sometimes I think, “You’re making it tough on us.” And being a clinician, you can tell sometimes that one objective won’t make or break this trial or treatment. But it’s make-or-break for my research team or turns off a patient from potentially going on a trial.

What do you see as the big tension points for providers participating in clinical research?

I think that billing is worked out for the most part. There can be some pushback from the research team because it can be complicated. I think it’s generally just work overload. I work solely in breast oncology right now: I have to say that makes it easier when I’m focused on one specific disease site because you know your protocols.

It’s not even that the protocols are extra work; it’s knowing what protocols are there. That goes back to, if you’re working in a team with an APP, that can spread out the workload. I was discussing this with a physician colleague the other day. She asked about a trial and I explained it. She said, “Really? And I didn’t know about it?” It was just her not being engaged in some of the new trials that we had opened within our NCORP. If you break up the workload, and it’s a team approach, like we do in everyday practice, it’s going to help make the workload more manageable. We can’t just be in our silos: “That’s research,” or “That’s care.” We have to think about it as standard-of-care so that everyone is involved.

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That’s where I’m a big proponent of APPs being more involved, because we’re the link between the treating oncologist and the research team.

Patients are overwhelmed. They get diagnosed, meet their oncologist, who lay out a treatment plan, and the patients are probably only taking in a small amount of that. If the next step is a research associate coming in to consent, there is a missing piece there. When I was first introduced to working with research by that oncologist, Dr Jonathan Cho, he said, “I want you to sit down and discuss it with the patients more,” because as the nurse practitioner, I understood how the treatment fit in with their cancer care trajectory.

A lot of it is education and explanation: bringing that down into the patient’s understanding. We have a really active patient advisory committee within our NCORP. They’re always asking what things mean. Consent forms are difficult for patients to follow, so sitting down and going through the consent form with them or explaining it in simple terms is really helpful.

Why have APPs not been utilized as much yet in bridging care and research?

We’re a growing profession. And I don’t think it’s always been a thought of the role we could play. There are some places out there doing it, but not many. I really think of how we can make a difference in four ways. Initial accrual: talking to patients. Conduct: following the patient on their journey. That is probably where we’re making the biggest impact already. There are some publications out there about APPs or nurse practitioners as sub-investigators. The third way is review of protocols coming into our practice: to see if they are truly feasible. Nothing bothers me more than opening up a trial and then we don’t accrue because it’s not feasible. But because we’re so involved in the clinic, we can see if a trial would work. And the final thing is protocol leadership, serving as PIs and developing protocols for symptom management and cancer control.

How do the current work and time requirements of clinical trials translate into the workload physicians and APPs already have?

Part of it is picking and choosing the right trials. Obviously, we would love to have everything available for our patients, but the reality is that we can’t always. We have to be realistic about what we can do, but we also have to be willing to think about clinical research as a standard of care and that it’s an important piece of our practice every day.

We have to be smart about it, because if you put all your resources into opening two lung trials, and you accrue one patient, and then a breast trial comes along, and we know we can accrue 10 patients, we already have the coordinators too busy on those two lung trials. That comes down to physician buy-in and flexibility.

I just presented a trial last week for one of our institutions, looking at patients with insomnia. It’s a pretty complex trial.

Fall 2021 Clinical Research as a Care Option Newsletter

Suzanne Rose, MS, PhD, is the Director of the Office of Research for Stamford Hospital, a community-based teaching hospital. Her role as Director entails overseeing all clinical trials and managing the research team. Under her guidance, The Office of Research encompasses the Clinical Trials Office, Center for Simulation and Learning and Office of Academic Research.

At CRAACO, you presented your work in developing a physician compensation model for clinical research. Who is encompassed within this model in your hospital and what was the previous system?

The model is for everyone. As a central research office, no one can do clinical trials without us being involved. That really helps us make sure that we’re not taking on trials that we can’t recruit to.

And then externally, we have physicians on the medical staff here at the hospital, and they have research projects that they would like to do. Sometimes they have a research staff, sometimes they don’t. So we contract with them. This model applies to everyone that we do research with.

The background is when I was at a different medical system, the way that they did physician compensation was essentially a fixed-fee or percentage model. The money that was left over at the end is what they would divvy up amongst investigators. The problem with that is that even though it’s very simple, where you say “We’re going to put 20% aside after all the bills have been paid,” you never really know if that aligns with fair market value. So it could be way over- or under-compensating them.

And so if you’re under-compensating them, they’re not motivated to participate. What if they do all this work and they didn’t recruit any patients, then there’s nothing left, right? There might be a little bit of startup fees left but for the most part, you’ve spent those in trying to get the study up and running.

There was a lot of dissatisfaction because it was so variable. There was never a match between the amount of work that went in and what they got out of it. So what I put together for them was a hybrid model that rewards the investigator for their contributions and it’s consistent with the financial success of the study. It’s creating a line item budget: we put the fees that we would agree to with the physicians.

For example: if you do a physical exam, you’re going to make this much money. If you do this SAE and AE assessments or if you consent the patient, these are the amount of dollars that you would get. The PI has a fee that’s built in.

We can pay them for their participation in the study startup visit or for the monitoring visit, and then we have a contract with them that says “This is exactly what you’re going to get for this study.” Obviously, the more patients they recruit, the more compensation they’re eligible to receive, but it doesn’t cross any ethical boundaries. If you recruit the patients, if you see the patients, if you’re doing the proper oversight of the trial, it’s all laid out right in the budget.

We have a third-party vendor who has helped us establish fair market value for our location. We’re in Fairfield County; behind Orange County, California, we’re one of the most expensive counties to live in because of our proximity to New York City. Based on where we are, and the specialty, there are different reimbursement rates.

This third-party vendor is completely external to our system and just takes data from where we are geographically, what specialties in our area make for certain activities, and refreshes them every three years. We’ve really found that it makes physicians happy, because they understand they’re being compensated according to where we live, and it’s great justification for the sponsors.

How unusual is developing a compensation model like this?

I always call investigator compensation both the best-kept secret and the worst kept secret, because no one wants to talk about it. I’ve been in clinical research for roughly 15 years. This was one of the first things I went to conferences to learn and nobody wanted to talk about it. There are a handful of papers that have been published on investigator compensation.

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Making It Feasible for Physicians to Do Research

Fall 2021 Clinical Research as a Care Option Newsletter

In addition to a compensation model, you developed a research coordinator workload assessment tool. Can you describe that and how that impacts the hospital’s ability to give research as a care option?

When I was at my previous organization, I was reporting to someone new. She came into my office and asked me, “How do you assign a clinical research coordinator to a certain trial?” I said, “I know who is busy and who can handle more.” Then I started thinking about it as a scientist: that’s not the right way to do something. We need data.

I started looking for clinical research workload tools. Just like the physician compensation model, there’s a paucity of information. There are several tools that have been developed and published on, but they don’t go any further. In addition, none covered non-oncology. With permission from a group, I took one of the tools and I developed it. It’s been hugely helpful at looking at performance management, justification for new staffing, and revenue justification.

We found out that with non-oncology coordinators, the higher their workload, the more revenue they produce. And the opposite was true with oncology coordinators.

It’s helped us go to the organization and say, “All my coordinators are at this workload. We want to bring in two trials, but I can’t give it to anybody. We need to hire someone.” A lot of different sites use this; it’s been very successful. I just had a meeting with the NIH in the last few weeks. They’re going to start using it for support of some of their trial arms where they have tons of coordinators, and we’re really looking for a way to justify staffing.

We’ve also looked at some metrics around job satisfaction, because if you can keep a coordinator in a certain range and not max them out too much, they’re more likely to be happy with their job and more likely to stay in their job.

What are your final thoughts on this subject?

I feel that as community-based hospitals, we need to make it a better environment for clinical research. It’s a challenge. No matter how many people you have that might be interested in doing research, I feel like the fact that we’re a community hospital fights against that ability for us to provide clinical research as a care option for our patients. I’d really love for community hospitals to understand the importance of research and putting aside dedicated time.

We need to, as hospitals, find a better way to protect time for our people who are most engaged in research, because it only elevates us as an organization, and obviously is paramount to taking the best care of our patients.

They describe the models, but no one wants to talk about what model they specifically use.

I tend to get a lot of traction when I talk about this. I believe a lot of places use this type of hybrid model, but I imagine at least 50% are using that fixed-fee or percentage-based model.

In this industry, we get a lot of guidance, but there are no how-to’s. I think people are scared to do physician compensation. So there definitely needs to be something that’s provided to investigators. I serve as an investigator on many trials; it’s a lot of work. You want to be compensated for the amount of the time that you put into that trial. What I’m trying to do is provide a how-to.

What is the reality like for a physician who is considering getting into research?

It’s actually very hard for new physicians or new investigators to become involved in research. It’s like when you go to apply for a job and they say you need previous experience; how are you supposed to get the previous experience if nobody will give you the experience?

Our industry is similar. When you’re filling out a feasibility questionnaire and they ask how much experience your PI has, if you put nothing, it’s difficult to convince a sponsor to give you a chance. Typically, what we’ll do is get our hands on a post-marketing study, or have them be a sub-investigator on a Phase III trial to get some of that research experience.

We are a community-based hospital. There are definitely physicians who want to participate in research; there are others who are not interested. It’s always an uphill battle to do research in a community-based hospital. But we do have a lot of younger physicians who are coming from places where research was very robust. They’re coming to us right away wanting to get involved. So it takes someone that’s excited and wants to do it and be part of it.

The last part of that is that our outpatient positions are based on a relative value unit (RVU) model. You have to get a certain number of RVUs at the end of the week, the month, the year, etc, to get your compensation. That fights with research, because if you’re fighting against an RVU model, which is their payment model. So on our end, we’ve created a research RVU and a work RVU. That way, no matter what, they’re paid for the RVU. That just takes work and it’s dedicated time. It’s a billing and finance group that understands what you’re trying to do. It’s hard, but it can be done.

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We need to, as hospitals, find a better way to protect time for our people who are most engaged in research.

Fall 2021 Clinical Research as a Care Option Newsletter

Narayanachar Murali, MD, is a Gastroenterology Specialist in Orangeburg, South Carolina. He is passionate about being able to offer clinical research as a care option to the patients of his practice.

How did you get started in clinical research?

Even as a fellow I was exposed to clinical research in my program, and actively participated in recruiting patients into trials. So when I started my own practice, I was in a place where we didn’t have numerous resources for patients.

In small towns throughout this country, it is a huge problem: there are no trials going on. It is often restricted to very big university centers, and it is a very impersonal experience for patients.

So then I realized if I’m going to have a private practice, this has to be an integral part of what I do. Because as clinical scientists, that’s what we do: constantly look for better answers and solutions. And I did several trials in different arenas, and eventually, I gravitated towards inflammatory bowel disease. That was partly because that’s an area that is of interest to me, and I treat a lot of patients with IBD. And the accepted treatments are not that great.

I felt let’s do it right, and help the patients and also help ourselves. That’s how it started, and now I have a very active clinical trials department in my practice. We engage every patient with IBD. We give them the option of standard treatment, and we also explain what are the trials available.

We have them right on the wall with detailed explanations of the mechanism of action of the drug, what pathways it affects and how it does it. We are able to communicate in very clear seventh-grade English as to how the drug works.

If they are convinced they’re gone to trial; if they don’t, we still treat them the regular way. We don’t make money the front and center issue in these trials. So it’s not “Because you don’t have insurance, you participate in a trial,” as much as “You have a disease that is hard to treat and I don’t have great answers with the current drugs.”

What is the process of enrolling in a clinical trial and recruiting a patient?

If a patient walks in with symptoms or signs of inflammatory bowel disease, we take down every detail and history. We go to great lengths to get accurate information on the charts, because it has to be done correctly, we concatenate all the information and we generate charts that are meaningful and easy to understand.

The best way is to gather all the information, explain to the patient what you’re doing, to instill a measure of trust, before you propose a trial. If I say, “You have a difficult disease. You have already been treated by multiple doctors, six different medicines, nothing’s working. What do you want to do?” So they’re okay with trials. And on our end, because we are well-known in the inflammatory bowel disease arena, whenever there is a new drug that is introduced, the company does contact us.

My wife, who is a full-time basic scientist and works with me, has experience in molecular biology, signaling pathways and in contracting. I do the clinical side, and she does all the regulatory work. It’s not easy to run clinical trials, even in universities. But we enroll more patients in my practice than in big universities in a given time; our target enrollment is reached within months, not years. So it is cheaper for the sponsors to work with us. Even though our review charges are much higher, it is worth it for them.

Do you find the protocols difficult to follow and work with?

This is what happens: protocols have become cut-and-paste from different trials. There is a fixed idea of what a protocol should look like, which is really onerous. Some of them are outdated in their methodology and thinking and they are not in tune with the digital technology. We created our own data collection sheet so that data is standardized.

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A Physician’s Perspective on Bringing Clinical Trials to His Practice and Patients

Fall 2021 Clinical Research as a Care Option Newsletter

What have you seen in regards to the increasing complexity of trials?

Trials have become more complex. Think of clinical trials as more of a legal experience than a medical one; it has become that bad. They are working on everything: the time/date stamps, what you write and what you say, etc. It’s almost like sitting in a court of law rather than a medical office. In the course of regular patient care, you’re not fixated on all of these things.

The main problem is space. For example, we do about eight to nine trials. Imagine the number of boxes that we get? This is where process improvement matters, because unless they have people who have that real-life experience, they are not going to improve things because there is no incentive for them to do it differently. They say, “This is how we have always done.” It can be a very frustrating experience dealing with regulatory overload. That is the main deterrent for trials. That’s why the enrollment is so poor. In my office, when a patient comes to me meeting the inclusion criteria, they are on the trial within 15 to 20 days, because we have streamlined. The days that we have clinical trial patients, we schedule fewer patients because they take up three to four times the amount of time in comparison.

If you had a wishlist of things that could be changed to improve your research experience, what would that be?

Number one is the non-replication of services, for example, labs, outside of very specific things like biopsies, can be done by something like Labcorp. I should be able to give a pre-printed slip of paper with the clinical trial number on it to the patient, who takes that slip and gets the labs, and I get the report. Labcorp can do a blood draw better than I can, and handle the specimen more confidently than us.

We are storing containers; I have to procure dry ice. These things should not be left to the people doing the trials. Just think of the logistics of doing all these things, with all these empty boxes sitting around specimen containers that are not used immediately. There’s a problem; they’re not thinking of the comfort of the user. Routine work that is done as a part of clinical trials should be given to people who regularly do this stuff. It’s a process improvement. So this is where if you take somebody like me who’s working in the field, I can point out where the bottlenecks are very quickly. I’m the person in scrubs, not in a suit.

The logistics of handling these specimens is becoming a big deal for us, and maybe a deal breaker in the future if clinical trials don’t change and make our life easy. They need to ask the question, “What can we do to make your life easy?” and then reflect that in the design of trials.

If you ignore the very people who are participating in the trial and conducting the trial, and you put them last in the list of regulatory things to do, you’re at a loss. Recruitment falters. The complexity of the protocol does not reflect the intelligence of the designer.

If a patient walks in, I don’t wait for the clinical trial company to say “This patient did not get the hepatitis vaccine or has not been immunized against shingles.” When an IBD patient comes in, we take care of all that as a part of the initial assessment. So by the time they’re enrolled into the trial, the usual rejections don’t happen and the exclusion criteria don’t include patients who shouldn’t be there.

What changes would you like to see to make it easier for providers like you to get into research?

It’s very daunting. Had I been doing this alone, I would not have, because it’s not worth it to spend time on this. I don’t recommend that anybody just jump into research if they are just looking to make some money. It may look big on the paper when they show you the budget, but the amount of work that is involved in getting it right is not easy.

There is so much paperwork. Since the introduction of the electronic methods of data capture, the amount of paper has gone up by five- or 10-fold. They have created more and more regulatory documents, more documenting and re-documenting and re-certifying, and more revisions that have to be filed in circular binders.

Even a trial with enrollment of four patients will generate almost a big cupboard full of files that we have to maintain for several years. And if you are in a small office, where do you put all these files? There are a lot of logistics that clinical drug companies don’t know about. It is unconscionable that they send boxes, measuring 3x3x3 feet, and ask us to send one tube of blood in it. They have better ways of doing this.

Often clinical trial designers are not practicing doctors, nor are they invested in a practice. They’re not actually experiencing the workflow problems that are thrown at us. It’s an unwitting mistake.

How do you present trials to patients?

We explain everything exactly as you would in a classroom. So if somebody asks, “How does this drug work?” I should be able to explain it to them without making them feel stupid. That means I have to understand it deeply, to be able to explain.

The clinical trial informed consent is too complex. It is loaded with legal verbiage more than medical consent language. It should not be that a consent is 20 pages long. It should be one page.

I’ve been doing it since 1995. You need to understand the budgeting process. You need to understand deeply what goes on and how much cost is involved in these procedures, otherwise you will run a loss. Unless you’re properly trained, it’s not easy.

There are no shortcuts to doing it. I strongly recommend having a clinical scientist or a basic scientist with clinical research experience running these trias, which I’ve been fortunate to have.

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Fall 2021 Clinical Research as a Care Option Newsletter

Suzanne Steinbaum, DO, is in private practice in New York City, and is the president of SRSHeart, a personalized lifestyle management program using anatomy, physiology, functional data, genetics and metabolism, along with technology, to reach ultimate cardiovascular health.

What do you think prevents providers from thinking of a trial as an option for their patients?

Healthcare has become really about the EMR more than anything. And the world is focused around doing what is needed to be done for that visit that are required by the EMR for billing purposes.

There was an article that came out in the Journal of the American College of Cardiology years ago, and the average time that a doctor could spend with their patient was eight minutes. That includes having a conversation, examining them, doing the electronic medical records, billing, coding, all of that, and the last thing on the list generally would be putting that patient into a clinical trial.

How do providers even hear about trials to then recommend to patients?

That’s the other issue. It depends where you practice. And if you’re in a big academic institution, unless you are affiliated or associated with the department that’s running that trial, you probably don’t know about it.

So as a cardiologist, if I see a patient who has Irritable Bowel Syndrome, and there’s a clinical trial going on in GI, I might not even know, because that’s not my department. In the community, we don’t hear anything, unless we actually look for it. And so there are patients and diseases that I will go out of my way to see if there are clinical trials for them. COVID shed light on the fact that we need a village sometimes to get information about how certain patients should be cared for. But unless we look and search, we are really not going to know.

What could be a way of setting up a system that shares information about trials?

After CRAACO 2020, I really started thinking about how we can do this better. And what becomes really challenging is that each hospital system, each academic institution, is running its own clinical trials.

So is that is that the right way we should do this,or should all patients be open to all clinical trials across all hospital systems? In New York, we know there is competition between hospitals. So how does that work?

There should be sharing of at least what’s happening. And this was a conversation that we had: we’re not sharing data, we’re not sharing outcomes. We’re competitive about research. We’re not inclusive about it. But if we really look at what the end goal is, which is really to find information, change healthcare and improve outcomes, then perhaps this research needs to be open up to everyone.

There’s a difference between the academic physician running the trial, who is going to get published and has their name on the paper, versus the physician who’s actually the clinician who needs that information in order to take care of their patients. Perhaps the silos of the academics can stay that way, but then it needs to be dispersed to the people who are on the frontlines really taking care of the patients. How does that happen?

I am a voluntary physician at Mount Sinai. I should be on the email list to be kept aware of what trials they have running. We don’t do that. It might happen in the hospital within the departments, but it’s not happening to the clinicians.

What is the typical clinician perspective of research?

That it is too difficult, that they’re going to lose track of their patients. There is bad communication between the researchers and the clinician. You send your patient out to be in a clinical trial, and you have no idea what’s going on. The patients don’t always know what’s going on. The researchers feel like they did the informed consent, but the patients might do that, and then walk out and have no idea what they’re doing. They might not understand what’s happening, or why they were put on medication. And we as clinicians can’t often get the information.

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One Physician’s Perspective on Increasing the Conversation Around Clinical Research

Fall 2021 Clinical Research as a Care Option Newsletter

So they standardized discharge forms: was the patient given aspirin? An ACE inhibitor? A beta blocker? There was a checklist. And when you have a checklist, your unconscious bias becomes less important. You just have to look at the objective data. This is when algorithms become incredibly important. But in saying that, does every person fit into an algorithm? And if they don’t, what happens to that person?

That’s when you become a physician, listening to the words and interpreting them. So if someone says, I’m having chest pain, and you ask all the appropriate questions, and they don’t fit into the box, then where do you go? You might find out that they’re having chest pain because they’re so stressed out and they don’t have enough money to buy food for their kids. Is it chest pain from heart disease? No, but it’s chest pain from some other serious stuff that we have to address. And if you don’t open your mind to the potential and possibilities of what something could be, you’re not going to be treating that patient thoroughly and in the right way.

If you could change one thing about how clinical research is done to better benefit patients and providers, what would it be?

Communication. It’s not a competitive sport, and it should not be siloed. We’re all working together to change healthcare, outcomes and health. The more that we can include patients, the more that we can talk about these trials and get patients enrolled, the better off we are. This protective nature, this siloed nature and this lack of communication has been one of the biggest problems. The academics will stay here; the clinicians are going to stay here and the people that are losing out are the patients.

It should be about opening it up to as many patients and giving access to as many people as we can. That would change everything if we could figure that out. And I believe that we can do it much more easily than we think.

You can query everything on an EHR. This has to exist, because we can query everything else. So why if I have a 50 year old woman postmenopausal with hypertension, does that not populate “These are the women and heart disease trials going on in your institution?”

Multiple hospital systems in New York City use the same electronic medical record. Why can’t we get that populated from the other institutions? As a physician at Mount Sinai, am I allowed to send my patient to NYU for a clinical trial? Let’s give patients the best access to all the trials that we can, with the idea that we’re not going to lose them, we’re still going to be in charge, the institution isn’t going to suffer, and we’ll all be better off at the end.

What is the ideal communication and what is stopping it?

There’s just no system set up for communication between practitioners between researchers. What is interesting is that I can think back to the day when we just had a paper research file. There could be such an easy way to communicate. It could be as simple as an email sent that says, “Your patient showed up. This is what we did today,” sent to the practitioner the second that doctor is put on the list.

Sometimes the practitioner is not even considered to be like the referring physician on file. If I send a patient to a GI doctor, I’m the referring physician. That doctor sees the patient, and I get a letter back that says, “I saw your patient. This is what we decided.”

I have one patient who went on a device trial. She kept asking me questions about it, and I had no information to give her. I would call and there was nobody to actually talk to.

What are the other incentives you think could be built into make clinicians more inclined to pursue research? Financial incentives are always interesting to think about; I don’t know how that works or if it could. I know some physicians in practices who were doing drug trials had financial incentives to get involved in those drug trials. But from my perspective, it’s all about “How am I going to provide the best quality care to my patients? If I bring them into a trial, will they get better care?” That’s always really interesting to think about.

For example, I’m thinking about women in heart disease trials. I might see these people once every four months, but they’re being seen on a monthly basis for a clinical trial. If it is a lifestyle intervention, we know the more frequent feedback there is, the better that people do. That becomes appealing to me, because my patients are going to be doing better if they get enrolled in these clinical trials. sometimes, these trials are really supporting the work that we’re doing in the office. And if it’s a support to the physician, that’s really appealing.

You discussed your passion for overcoming the bias of women not being offered treatment at CRAACO 2020. How do we make changes to patients being offered research?

I spend an exorbitant amount of time thinking about these things. There’s a true unconscious bias. This is when data and technology can become so important. It started with heart failure. The biggest readmission diagnosis, and it still is today, was heart failure.

It was because there wasn’t a standardization of medication when those patients were discharged. And by the way, we see this across the board in multiple trials with women with heart disease. Women who get discharged from the hospital don’t get the same life-saving medical care that men do, they don’t get referred to cardiac rehab, etc.

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In New York, we know there is competition between hospitals. So how does that work?

Fall 2021 Clinical Research as a Care Option Newsletter

From the archives

At the 2021 Clinical Research as a Care Option meeting, Dr Janet Woodcock, acting FDA commissioner, and Dr Laura Esserman, UCSF Carol Franc Buck Breast Cancer Center, discussed how to integrate clinical research into clinical care in a seamless manner and bring research to more patients in the process.

“Clinical trials are how we make sure our care tomorrow is better than it is today,” said Dr Laura Esserman. They offer opportunities to learn, to offer the highest standard of care and provide potentially life-saving treatments.

“[During the pandemic] we didn’t have trained investigators and we didn’t have research infrastructure outside of the traditional channels, and they quickly got clogged up,” said Dr Woodcock.

Dr Woodcock and Dr Esserman noted that the pandemic unveiled the issues that existed in the clinical research system and highlighted that there wasn’t always the ability to learn from most of the patients being treated for COVID-19.

On the clinical research side, Dr Woodcock mentioned that only about a small fraction of COVID-19 patients were in clinical trials for treatment.

And on the care side in the pandemic, practitioners were trying everything to give adequate care to their patients but there is not the built-in ability to source data and learn from it in a cohesive manner in a systematic way.

“What’s missing in clinical care is a feedback loop so we know what works and what doesn’t work,” said Dr Esserman.

These issues highlighted the potential for clinical research as a care option: to bring more patients into clinical research, and also give practitioners the resources and ability to learn more about how to best treat their patients.

“If we want to accelerate change in clinical care, we have to get the change in mindsets, skillsets and toolsets,” said Dr Esserman.

Dr Woodcock saw the solution of improving clinical research and as involving community practices as ongoing sites to create a larger and more constant capacity that can be quickly ramped up into a study.

Most sites during the pandemic were concentrated in big cities or academic centers, rather than in community practices. In addition, the vast majority of clinical care sites aren’t trained or prepare to participate in clinical trials.

“So not only are the patients denied an opportunity to participate, but the practitioners are also denied the opportunity to participate in clinical research,” Dr Woodcock said. “So we lose in diversity; we lose in enrollment; and I think we lose in equity.”

This community research, Dr Esserman added, would also serve the additional purpose of solving smaller sticking points that can prevent rapid uptake of research.

“That’s why I think we need to build an integrated research structure within clinical care, at a time that isn’t an emergency, so that we can confront these problems and work through them one by one,” said Dr Woodcock. If there is a network up-and-running and conducting studies, it’s much easier to repurpose that than to build it from the ground up.

By continuing to keep these sites fully operational in between emergencies through conducting research, Dr Woodcock pointed out that they can provide research that benefits the community.

“Our mindsets should be that we are collecting data in the clinic where we have checklists of data that are mission-critical pieces of information: we need to know who is this person, what treatment are they getting, and how did it work?” said Dr Esserman.

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A Vision for the Integration of Clinical Research and Care