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This presentation was part of the Oncology Workshop session at Magi East-2014 in Philadelphia. Oncology Clinical Studies have not enrolled well in the United States and new strategies and solutions should be used to achieve our goals. There are unique suggestions and tools that can be used throughout the pharmaceutical and biotechnology position and whether these tools are used for oncology studies or other therapeutic areas these methods are provided to provide new ideas that can achieve greater results. Don't live in hope thinking running trials the way you have always done it. Try some of these techniques and you will achieve better results.
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REGIONAL EXPERTISE IN A GLOBAL MARKET
Time to Roll up our Sleeves and Focus on
Solutions and Strategies to Get Past Living in Hope on Enrollment
Dan DiazVice President, Global Business Development215-348-3543
Is the Trial Balloon Rising?
Overview
19 years in the CRO/SMO space has provided a
perspective on how companies attack enrollment
solutions
Observation from conferences and from meetings with
sponsors, sites and vendors has shown that the standards
are still the same
SPRI founded in 1972 as a Clinical Site
Leading to our site strategies for achieving enrollment
Focused on being different in our approach
Setting the course for identifying new tools and
expertise
10th anniversary as a Specialty CRO
The Focus for Today
We are calling this a “WORKSHOP” Time to roll up our sleeves
Share Ways that Work- for your projects
Find out what “We haven’t done before”
Explore some of these tools Informed Consent Revisions
Patient and Physician Outreach
Community Intervention/Patient Advocacy Utilization
National Enrollment campaigns
Point of Care information
Patient Advocacy Campaigns
Patient Education
Discuss “Why it did not work”
OK- Let‘s Set the Baseline Where are we from?
Community Centers in Hospitals
Academic/ Private/ Group
Sponsor/Biotech/Pharma
What percent of your office physicians participate in
trials? Do you have a patient advocate for clinical studies?
Does the Hospital have one?
For the Pharma’s/CROs - do you support payment for
advocates/ clinical trial materials/ publications at the
site level for Oncology Trials?
How do you work that into your budget?
Do you expect the CRO to put that in their budget
upfront?
If no, does your company do this for other indications?
Time to Roll up our Sleeves
Our goal is not to debate but Share Ideas
• Get a pen • Get your texting
ready• We are asking for
your feedback
Questions write or text answers to 913-706 9052
1. What 3 Ways does My group approach patients? physician level, Nurse level, Institution level
2. What are the top 3 ways your institution educates your patients/families on clinical trials?
3. List 3 “other methods” you haven’t tried but have interest in learning
4. What 3 cancer types are “easy for your clinic to enroll?” 5. What 3 types are harder? 6. What percent are Supportive Care trials?7. Question for the group- Do we share that information with other
cancer centers in the area?
8. Why is your site selected for XX indication?
9. What are the top reasons why you are not chosen?
10. What are you willing to do to change?
Pens and Phones Down Time
The Frustration Within Oncology Trials
8% of US Based Oncology trials enroll on time Only 1-3% of US patients with Cancer participate in clinical
trials Drug development delays within the trials are leading to many
company’s financial strife
Hesitation to try new things runs rampant Reluctance to build in strategies upfront is Sponsors dilemma
Have you ever heard the following? “It is always the CRO’s Fault” The sites aren’t meeting their enrollment projections”
So what are we doing to be successful?
What is helping us overcome these situations?
What has made us successful?
The Living in Hope Method- The CRO Here’s a list of methods that CROs always talk and write about…
Beware- Living In Hope and Running Studies the way they always have Pod Calls, 1 hour per week site management Study Coordinator Calls Send Candy Standard Feasibility to their Database of Sites
“Feasibility sent to 100 sites…” Do they really know them? Do they have a Freezer? They don’t ask- “How often do you use XXX on your patients with YYY cancer
IF XXX is not readily used- SOC in that center- would they enroll patients in that trial? Not usually
If they are a $1 B CRO, and 35 % of their studies are Oncology, and only 20% of the subjects are getting enrolled in the US, how’s their database?
Potential Strategy- Don’t add more sites- add countries 6-8 month start up in an academic site is longer than time in Georgia/Poland/Belarus
Some countries you can be up and going in less than 3-4 months (even in oncology)
Clinical Trials Landscape
Retention
Recruitment
Awareness
CISCRP
Can’t run trials your Mother’s Way
Patient Feedback- An Interview Patient diagnosed with Thyroid Cancer in 1999
– Just enrolled in his second clinical trial.
Reason for Participation First trial- Doctor did not like prognosis after relapse and surgery
To be cured or be cured enough to go on and be in a position to be cured later on
How did he find out about Clinical Trials in Oncology He was NOT approached about studies in 1999 when he was first diagnosed
Not until relapse -and more surgery in 2007 was he approached about trials by his Oncologist in Nebraska
Found a trial in St. Louis and he flew back and forth for 6 years
PEARL- the local site performed all labs, x-rays, procedures
St. Louis Site performed all dosing (second study is still set up the traditional way)
None of his travel costs or mileage were covered by the sponsor
Since 2007 I was told that he was in a pharma study using Sutent I was upset that the sponsor did not reimburse his travel costs
It was then found out that it was a study sponsored by NCI
Why I was happy- they kept him on study (challenged assessment of PFS- board agreed)
Outcome- Longest Living Survivor
Patient Feedback Progression finally led to ending study Question- Why wasn’t he informed about trials during initial diagnosis?
His feeling was that “we” the industry only wanted to get patients who had no chance of cure and were really in bad shape.
What else did I learn? Informed Consent and Education Material Asked- between 1-10 what was his understanding of the IC
Answer 4- he did not really understand what was expected, covered and his requirements
2nd study- What was your understanding of the IC
He called it a disclosure and said that it was much clearer and easier to understand
He said he rated it between a “5-6” for his understanding
I asked him “why he felt that way” and he said he was a “lay person” and did not have the training
Here’s the Rub- He has a Masters degree and is a Lawyer
He had a hard time explaining what he was to do and had to overcome being scared to participate- Friends and Family- at first thought he should NOT participate
Patient Suggestions for Investigators and other Patients
He said that some of the Patients that he talks to Say they felt pushed to get involved in Placebo Controlled Studies (Pharma Sponsored?)
He said that he did not want a Double-Blind study as he wanted to be Cured or to be good enough to get to the next therapy that could cure him”
Suggested that “we”- Doctors offices” inform and train patients to ask questions
“Be Willing to offend the Doctor”
Be willing to ask tough questions- why would/would not have me enroll in a trial?
Why did you not tell me of clinical trials?
What is the compensation for the clinical trials? Am I a Guinea Pig?
Get Materials in the hands of the patients- before they are Diagnosed
My Take as an industry, we need information on clinical trials, in every office, our websites
He recommended magazines to be available He Knew “Cancer Today” and “CUREMagazine.com”-
recommended- as CureMagazine was easy to understand
Change CC.Gov It is too difficult to understand- He found the second study himself!
Most Importantly – Help the Patients Set Goals
John’s Initial Goals
• See his oldest boy Graduate High School- • He’s a Sophomore in College
New Goal• See his Youngest graduate High School
• Be A Grandfather • AFTER they graduate college
• “My goal is to be cured, or be good enough to make it to when a cure is found and available!”
• What goal to you have for “My Industry”
• Educate us before we get sick and need you
REGIONAL EXPERTISE IN A GLOBAL MARKET
So Let’s Get Busy!
Strategies and Solutions
You saw the data on the Patient’s Understanding
Let’s set the baseline
• How many of you write your own Informed Consents?
• Who writes those for you?
• How many of you Accept and use the Sponsor/CROs?
• How many of you have used Color?– Pictures
– Charts
– Imbedded objects?
– Patient Information Materials (in addition)
• Was it a Pharma/Bio sponsor or a Government Sponsored Trial?
• Do you believe that the real concern to not use these is the legal
risk?
Pie charts of patients receiving a patient information form (top pie, n = 365) and their decision to sign an informed consent form (second pie), their eligibility after signing (third pie), and their final ability to start in a specific phase I trial (bottom pie).
van der Biessen D A et al. The Oncologist 2013;18:323-329
http://theoncologist.alphamedpress.org/content/18/3/323.full
Informed Consent That Truly Informs
A study of clinical trial Informed Consent Forms (ICFs) found that
about 90% of ICFs are written at an 11th-grade level or higher. That
level is far too high because:
In the United States alone, more than 90 million people have
difficulty reading
1 out of 5 Americans reads at or below the 5th grade level
The average American reads at an 8th-grade level or below
Approximately 8 million US seniors have below-basic
literacy skills
Literacy levels are even lower in many of the
countries where clinical trials are often conducted
A Knight’s Tale (10th Grade Level)
Whilom, as olde stories tellen us, Ther was a duc that highte theseus; Of atthenes he was lord and governour, And in his tyme swich a conquerour, That gretter was ther noon under the sonne. Ful many a riche contree hadde he wonne; What with his wysdom and his chivalrie, He conquered al the regne of femenye, That whilom was ycleped scithia, And weddede the queene ypolita, And broghte hire hoom with hym in his contree With muchel glorie and greet solempnytee, And eek hir yonge suster emelye.
Yes, this is from the real book
22
Let Me Make it Easy (6th Grade Level)
• Theseus was the governor of Athens• He took over many countries• When he conquered Scythia he married
the queen, Hippolyta• He brought Hippolyta and her sister
Emily back to his country• There was a great celebration
Now I understand 23
New Informed Consent Suggestions
Lower the reading level to a 6th grade level
Reduce/replace legal and medical jargon-
Develop Patient Resource Guides-if IC is already approved
Use plain language
Include phonetic pronunciation (pro-nun-see-A-shun) guides Pra-STATE not Prostrate - Patients “feel better” when they pronounce it correctly
Add pictures, icons and other visual elements
Take home “booklets” of the Informed Consent
Use more white space
Provide patients with clear, easy-to-follow schedules and calendar
Work with Medical Writing groups- education agencies who perform
this.
This isn’t normal standards for CROs
Patient Education
Top Sources for Clinical Research Information
Upfront Patient Education- Question for Sponsors and CROs
When you go to the site- look for Waiting Room information on
participation in clinical trials
Provide hand out information and call center information on
cancer within indications and advise them to go to “Pro-Clinical
Study” websites and organizations
Patient Resource Guides
Branded Materials- take-home kits
Provide material to local non-profit chapters
Provide them with a list of sites and information on clinical
trials
Patient Education/Retention Materials
Broadcast media, including television, radio and newspaper
Direct mail to targeted demographics
Recruitment website
Search engine optimization for disease-state searches
Social media posts
Healthcare professional office materials, including easels, brochures, posters and
study overview and eligibility requirement handouts
“If you can make something easier, more convenient, more straightforward and
easier to understand, patients will improve their level of compliance,” John Yates, MD, executive director of clinical research at Merck Research Laboratories.
Shelton D. Patients in clinical trials don’t always follow the program.
American Medical News.
http://www.southjersey.com/articles/?articleID=2171. Accessed March
28, 2013.
Clinical Trial Solutions
Web-Based
Web keys for quick web access-even for kids
Websites that guide the patient/family member to the right resources
Outbound recruitment
Telephone scripts Newspaper ads Radio scripts
Informed Consent
Patient guide to informed consent
In-Office recruitment
Nurse inclusion/exclusion criteria Educational wall charts Patient brochures
Patient Resources
Appointment reminders Post cards; magnets
Health-literate trial education
Patient Information (study specific)
Sponsors Should Take the lead on thisMid size/larger have the Medical Education teams.
CROs don’t usually put this in the budget as it “makes their costs higher than the competition and
THEY aren’t asked for these types of solutions
For what percent of your studies do the sponsors provide these types of
materials?
Clinical Trial Integrated Services
Patient web-keys for quick access
to the global websiteAnd Study Information
Interactive educationalwebsite
Recruitment materials in a box
Peer-to-Peer Education
How many times have you had MD to MD training or Discussions
from CRO or Sponsor?
In-Office HCP-Facilitated Education
Whether for Study or Condition- Do you find these Helpful?
Patient Engagement and Retention Strategies
So where are we with Technology
Technology tools
Use new Survey technology and search electronic databases for
patient information
Survey technology saves time and money and provides better
data in faster time
Site Portals –being used for increased communication
Use the Web for patient recruitment including
Texting, web, adverts on Pinterest, Non-profit orgs
Open up for Skype and video calls
Community Tools- Shared experience and success
Enrollment methods- Yes even in oncology
Pinterest, patient/patient, community outreach, Facebook, Website
Mobile is only for teenagers, It only works in the US- FICTION
39
122- Number of mobile-cellular subscriptions per 100 Developed World inhabitants (ITU 2011)
40
UK-based study –Texting• www.linkedin.com/pub/joann-miller/2/22/844
95%
18%
0% 20% 40% 60% 80% 100%
Text
Phone
“No Show” rate for people who received SMS reminders was over 20% lower than those who
received phone reminder
How many of you use this method?
Study subjects had a strong preference to receive visit reminders by text over phone.
Faster Site Selection and Process
Geographical Location
Patient Population
Staff Credentials
Facilities
PAST HISTORY
Recruitment
Responsiveness
Feasibility
Create meaningful questions Survey & CDA – automate! Tracking – automate! SEV – when needed Selection recommendations
In Summary
Do not live in hope -Enrollment Just Doesn’t Happen If you are doing things the same way and they haven’t worked do
something different Redo the IC- Can your Family understand the IC? Test it! Use CROs and 3rd Parties to develop these Tools it will develop a strong
call-to-action message Engage the investigator through a new, unique way of discussing the
disease and clinical trial opportunities Use new Technologies as it helps patients with adherence and
compliance Empower investigators to educate patients
their own way (customizable) Track how the patients have found out about your studies. If they found you- great- but you should be finding them
Thank you to my contributors
Dan Chupka Infinata, Inc.dchupka@infinata.com781-762-9158www.biopharmclinical.com
Brian S. Schaechter973-727-3768bschaechter@artcrafthealthed.comwww.artcrafthealthed.com
ddiaz@spriclinicaltrials.com www.spriclinicaltrials.com
Susan MH LewenzLitéra AxxiTRIALS+1(336)375-29x142 SLewenz@Litera.com
Medikidz USA
716-597-9073
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