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Volume 24, Issue 19. © 2020 CenterWatch
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see New ICH E6 on page 8 »
see Pandemic Is Expediting on page 7 »
May 11, 2020
COVID-19 Update…2
Industry Briefs …3
Up and Coming…5
Drug & Device Pipeline News…10Twenty-eight drugs and devices have entered a new trial phase this week.
Research Center Spotlight…12
CenterWatchWeekly
By Elizabeth Tilley Hinkle
Just two years after releasing a major re-vision of its good clinical practice (GCP) guideline, the International Council
on Harmonization (ICH) is planning a new update that would require additional adjust-ments from sponsors and sites that still may be trying to catch up with the first revision. Surprisingly, the COVID-19 pandemic could end up making that task easier.
ICH announced in November 2019 that it planned to again revise ICH E6 — Good Clinical Practice, to fill gaps in areas of the guideline that were not addressed in a 2016 revision. ICH’s announcement that it would revise E6 again caused consternation within an industry still grappling with challenges pre-sented by the 2016 revision, known as E6(R2).
The introduction in E6(R2) of risk-based management and quality tolerance limits (QTLs) caused the biggest problems, Crissy MacDonald, vice president of client delivery at life sciences consulting firm The Avoca Group, said at a CenterWatch webinar last week. She noted that difficulties in these areas could, in fact, greatly affect individual organizations’ ability to comply with the upcoming E6(R3).
According to a poll of 188 industry repre-sentatives attending the May 5 CenterWatch webinar on the forthcoming E6(R3) guid-ance, a mere 8 percent have successfully completed adoption of the current E6(R2) and 17 percent were less than halfway through that process. Another 31 percent
New ICH E6 to Place More Demands on Trials, but COVID-19 Could Help Ease Adjustments
By James Miessler
The worldwide rush demanded by the pandemic to develop and/or identify a potential treatment or vaccine
has culminated in remarkable success in expediting COVID-19 trials, and the lessons learned are likely to be applied even after the pandemic is over.
The pandemic has led to a rapid speed-up in the time it takes to get from protocol finalization to first patient visit for COVID-19 studies. Investigators normally would finalize their trial protocols in a six-month process — perhaps three with great efficiency — and then proceed with site selection, contracting, budgeting and other tasks. Now, the majority of COVID trials are going from having a final protocol to first patient first visit in just four
weeks, says Suzanne Caruso, WCG Clinical vice president of clinical solutions.
“We have a virus that basically didn’t exist five months ago, and now we have more than 950 active trials,” Caruso said at a WCG Clinical webinar last week. “Those are indus-try-sponsored trials, those are investigator-initiated trials. I think [the pandemic] forced a speed, and speed to getting trials ongoing is going to have a lasting impact on the clini-cal trial landscape beyond COVID.”
The numbers show that non-COVID, industry-sponsored trials have seen an enormous deceleration in participant en-rollment and a massive increase in holds as a result of the pandemic. Prior to January, seven clinical trials were put on hold per
Pandemic Is Expediting Protocol Finalization in COVID-19 Studies
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COVID-19 Update
COVID-19 Drug Research Roundup Below is a roundup of research activity on COVID-19 vaccines and treatments for the past week. To see last week’s column, click here.
COVID-19 Vaccines:Pfizer and BioNTech have begun a U.S.
trial of COVID-19 vaccine candidates at the NYU Grossman School of Medicine and the University of Maryland School of Medicine. The phase 1/2 study will assess four mRNA vaccine hopefuls in one continuous trial that will involve 360 healthy subjects be-tween 18 to 55 and 65 to 85 years of age.
Predictive Oncology is developing a COVID-19 vaccine using a novel nanopar-ticle vaccine platform. The company said its next move is to seek quotes for a phase 1 trial from CROs approved by the HHS’s Biomedical Advanced Research and Devel-opment Authority (BARDA).
Moderna is planning to begin phase 3 trials of its coronavirus vaccine by early summer, speeding up its original timeline that had the trials starting in the fall. The agency recently cleared a phase 2 trial for the vaccine candidate, mRNA-1273, which involves approximately 600 participants.
COVID-19 Treatments:Montefiore Health System, Albert
Einstein College of Medicine and NYU Langone have launched a clinical trial studying the effectiveness of convalescent plasma in COVID-19 patients. The trial will enroll 300 people that have COVID-19 respiratory symptoms, with half of them receiving a placebo.
CTI BioPharma has begun a phase 3 trial to evaluate its oral multikinase inhibitor pacritinib in patients hospital-ized with severe COVID-19. The trial, which is expected to enroll patients in both the U.S. and Europe in May, will compare pacritinib plus the standard of care to placebo plus standard of care in 358 hospitalized patients.
London’s Guy’s and St. Thomas’ Hos-pital will run a trial of convalescent plasma for treating COVID-19. The treatment uses do-nated blood plasma from patients that have recovered from the virus and transfuses it into COVID-19 patients whose bodies are not making enough antibodies to fight the virus.
Glenmark Pharmaceuticals has re-ceived approval from the Indian government to conduct COVID-19 trials of the antiviral favipiravir, which is approved for treating influenza in Japan. The randomized study will have 150 mild-to-severe coronavirus patients.
Massachusetts General Hospital will conduct a trial of Mallinckrodt’s INOmax (nitric oxide) for treating low blood-oxygen levels in patients with severe COVID-19 lung complications. Mallinckrodt previously received Canadian approval for a trial of high-dose inhaled nitric oxide therapy to treat COVID-19 infections and associated lung complications.
Eli Lilly and Junshi Biosciences have teamed up to develop antibodies that can potentially prevent and/or treat COVID-19. Eli Lilly and Junshi plan to begin clinically testing the lead antibody, JS016, in the second quarter of this year.
Vir Biotechnology and Alnylam Phar-maceuticals have identified an investiga-tional therapeutic, VIR-2703, as a possible COVID-19 treatment. The inhaled SARS-CoV-2-targeting small-interfering RNA (siRNA) blocks production of specific proteins and could prevent or treat a coronavirus infection.
Anixa Biosciences and OntoChem have identified a potential COVID-19 therapeutic
agent and have advanced it to testing. The drug is designed to disrupt interaction of the virus’ endoribonuclease with a protein necessary for its replication.
Amgen said it has plans to test its block-buster psoriasis drug Otezla (apremilast) as a possible coronavirus treatment. The com-pany expects to begin trials of the drug in the coming weeks and is looking to study the drug in multiple scenarios. Amgen CEO Rob-ert Bradway said the drug could help prevent respiratory stress in late-stage patients.
Incyte and Novartis plan to initiate another phase 3 COVID-19 trial of their JAK inhibitor Jakafi (ruxolitinib). The study will evaluate the drug in coronavirus patients on mechanical ventilation and ones who have acute respiratory distress syndrome. The two have already launched a trial of the drug on COVID-19 patients with cytokine storm.
Researchers at Royal Oak, Mich.’s Beau-mont Hospital are enrolling patients in a phase 2 trial to evaluate a combination of naltrexone and ketamine as a COVID-19 treatment. The study is trying to determine if the combination can lessen the severity of symptoms by reducing inflammation.
CSL Behring Australia said it is cur-rently developing an anti-coronavirus plasma product for potential use in Aus-tralia. The treatment, known as COVID-19 Immunoglobulin, is being designed for severely ill patients, particularly ones that are progressing toward being put on ventilation. It is being developed at the company’s advanced manufacturing site in Broadmeadows, Victoria.
© 2020 CenterWatch CWW2419
WCG | CWWeekly May 11, 2020 3 of 12
Industry Briefs
WHO Outlines Criteria for COVID-19 Vaccine Challenge TrialsA working group of the World Health Orga-nization (WHO) has indicated its support of COVID-19 vaccine challenge studies, but made it clear that those trials must meet eight conditions for them to be considered.
In its guidance, the WHO working group made it clear that there needs to be scien-tific justification, an assessment of potential benefits, fully informed consent of partici-pants and a focus on enrolling only healthy, young adults who are considered to be at low risk of serious disease.
The report noted healthcare workers and researchers would be appropriate partici-pants for a COVID-19 challenge study, as they have a higher probability of infection and are informed about the risks associated with the virus.
To read the full WHO report, click here: https://bit.ly/2A3UE2m.
Pharma, CRO Fates a Mixed Bag as Pandemic ContinuesPharma companies and CROs are expe-riencing ups and downs in the second quarter of 2020, with some fighting to keep their trials afloat amidst pandemic uncertainties while others are slowly get-ting back on track. Here’s a sampling of what happened last week:
} Amid the uncertainty surrounding the COVID-19 pandemic, PRA Health Sciences says it has been working to mitigate the effect of the pandemic on its ongoing studies by using its mobile health platform and remote moni-toring technology. Gathering data remotely and supporting virtual trials will help the CRO limit the exposure of staff and conserve valuable resources.
} PPD says it also has been feeling the pandemic pain as some of its cus-tomers delay new studies or pause ongoing studies or activities such as
recruitment, enrollment, site visits and monitoring. PPD says it is working closely with customers to minimize trial disruptions and ensure continued access to drug supplies for patients in ongoing studies. In March, the big CRO launched a new program to transfer participants in an affected trial to other research sites. PPD also reports it is working on 39 studies related to COVID-19 treatments and vaccines.
} In a recent report, Ironwood Pharma-ceuticals announced it has paused enrollment in a phase 3 trial of its re-fractory gastroesophageal reflex drug, IW-3718. Most trial sites have stopped in-person screening activities but continue to monitor patients already enrolled and being treated, the com-pany said. As a result, Ironwood will not have top-line data ready to report by the second half of 2020 as planned. On the other hand, the company’s collaboration with Allergan on a phase 2 trial of MD-7246, a drug to relieve abdominal pain resulting from irritable bowel syndrome, is moving forward and has completed patient dosing, which will allow it to share top-line data in the second quarter of 2020, earlier than the planned target of mid-2020.
} As many clinical trials continue to slow down and some stop altogether, one UK biotech is looking to hit the restart button on enrollment of a phase 3 study. NuCana has announced that it will recommence recruitment of new patients for a study of nucleotide analog Acelarin plus cisplatin for the treatment of biliary tract cancer. The phase 3 trial is designed to enroll up to 828 patients across 120 sites. The first sites to reopen are located in Australia, Canada, South Korea, Taiwan, Ukraine and the UK.
New Transplant Guidance Recommends Endpoints, Trial Designs for CMV DrugsSponsors of drugs to treat or prevent cyto-megalovirus (CMV) disease in organ or stem cell transplant patients may use CMV blood levels (CMV viremia) as a validated surrogate endpoint, according to a guidance the FDA finalized last week.
For trials of preventive therapies, participants should have no detectable post-transplant CMV infection within five days of beginning therapy. Treatment trials should enroll organ transplant patients with virological evidence of CMV replication or stem cell transplant recipients with clinical evidence of tissue-invasive CMV disease.
Read the final guidance here: https://bit.ly/2YXh0xd.
New Research Platform Seeks to Improve Collaboration Across COVID-19 TrialsThe COVID-19 Collaboration Platform (COVIDCP), a new initiative from universi-ties and clinical trial organizations across the U.S., will bring together research teams who are working on vaccines and treat-ments for COVID-19.
The research teams can share trial pro-tocols and data, and aggregate and analyze evidence as well as receiving support for developing multisite trials, and free data storage and anonymization.
Partners of the 10-member COVIDCP include the Johns Hopkins Department of Biostatistics, the Harvard Data Science In-stitute, the International Forum for Acute Care Trialists (INFACT), Drexel University Dornsife School of Public Health, and the McGill Department of Epidemiology, Biostatistics and Occupational Health, among others.
Trials posted on the COVIDCP platform are open for collaboration. Learn more about COVIDCP here: https://bit.ly/2LcxyJk.
continues on next page »
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Industry Briefs (continued from page 3)
New Survey on How COVID-19 is Affecting Clinical Trials Shows Major ImpactA new survey of investigator sites reveals approximately 69 percent of respondents said lockdown measures have impacted their ability to conduct ongoing trials and 78 percent said COVID-19 has affected their ability to start new trials.
Only 11 percent of the 1,030 respondents said they were “extremely concerned” about their ability to collect clinical outcomes data during the pandemic. The global survey was conducted by Medidata the week of April 23.
More than half (63 percent) of survey respondents said they have stopped new pa-tient recruitment for an ongoing trial, whereas 43 percent said they have delayed their study. Only 12 percent of sites that responded to the survey have said they cancelled studies.
Nearly 45 percent of respondents said they have switched study participants from in-clinic visits to virtual/telemedicine. Around one-third (33 percent) of respondents said they have amended their study protocol, and another third (32 percent) have said they have not allowed randomization of patients who have completed screening.
On a scale from one to five, with five representing “being extremely concerned,” respondents were most concerned with their ability to enroll (weighted mean: 3.73) and recruit patients (3.66). They also reported concerns about financial implica-tions for cancelled trials (3.42) and patient access to the research site (3.05), among other concerns.
The survey also revealed that only 8 per-cent of respondents have tested patients for an active COVID-19 infection. Only 3 percent tested patients for prior infection.
Respondents also suggested that deci-sions to postpone a trial or halt recruit-ment should be made on a region-specific basis, as COVID-19 is not affecting all parts of the world equally. To ensure they have additional financial support to employ study coordinators during delayed or sus-pended studies, sites suggested contracts should be amended for increased remote monitoring work and increased overhead reimbursements. Also, sites commented that they want sponsors and CROs to develop study-specific contingency plans to prevent deviations from scheduled visit windows in case another outbreak occurs in the future.
The majority of respondents were from the U.S. (58.3 percent), followed by Asia (23.8 percent), the EU/UK (8.1 percent), South/Central America (7.1 percent) and Middle East/Africa (2.7 percent). Respondents were mostly study coordinators (73 percent), followed by investigators (11.2 percent), directors (5.4 percent), clinical nurses (4.1 percent) and “other” (6.3 percent).
To read the survey, click here: https://bit.ly/2Li3qMt.
ACRP Launches Fund to Help Sites Educate Workforce During COVID-19To support research teams at sites struggling with the impact of COVID-19, the Associa-
tion of Clinical Research Professionals (ACRP) has set up a Clinical Research Site Sustain-ability Fund to provide grants to sites for continuing education and career develop-ment resources.
The fund is part of ACRP’s Partners in Workforce Advancement initiative, which is working toward setting standards for work-force competencies and fostering diversity in the clinical trials industry.
ThoughtSphere Acquires Patent for Platform That Quickly Intakes, Processes Study DataThoughtSphere, a cloud-based clinical data management provider, has secured a patent for a data management plat-form that uses statistical and machine learning methods to map, aggregate and standardize clinical trial data from disparate sources.
The new data management platform adapts to any data structure and source — including electronic data capturing systems, electronic medical records and wearables — and allows for the conver-sion of these trial data to a standard-ized format. According to the company, clients who use the newly patented tool have reduced data management costs by 30 percent and have saved approxi-mately 50 percent of time in their data management efforts.
Through the end of the year, Thought-Sphere is offering the platform for free to clinical trials focused on COVID-19.
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Your leading resource for trends, analysis, compliance guidance, expert insights and more. With original content and exclusive interviews in each issue, The CenterWatch Monthly is like having your own full-time research team helping you understand how and why the industry is changing.
By John W Mitchell
Frustration about clinical trial start-up costs is not unlike Sisyphus’ dilemma. A host of long-standing expense and
such uphill headwinds for the clinical trial sector. According to some sources, such problems even threaten the viability of the sector. Sites complain they incur more over-head costs driven by regulatory documen-tation, antiquated data collection and the demands of precision medicine to name a few — all without increased compensation from sponsors and CROs. A recent study supports this concern. Researchers at the
-opment found that the study start-up phase
remained unchanged for the past decade. -
ing investments in technology are getting trials done faster. None of this bodes well for smaller, independent players.
-sley, CEO at IACT Health. His company
-ger, and there are more procedures per pa-tient per day. So, you’re doing loads more work, but you’re only paid when you put
themselves — you put fewer patients in tri-als today.”
According to Kingsley, the only way to -
pate in three times as many concurrent tri-
from an overhead standpoint to have one trial that places eight patients, rather than three trials that place eight patients.
Also, at a time when technology is con-
technology is compounding problems in the clinical trial sector. In each of the three
sponsors. When each sponsor uses their own networks and devices for patient-re-ported outcomes, it adds to site workload and time.
“We have no ability to standardize tech-nology,” Kingsley says “We have to do so many trials with so many sponsors, and they have their own decision-making…
-bia (standardization between sponsors and sites).”
As an example, he cites the advantages of sites adopting electronic platforms such as eSource. Using such a platform could save billions compared to the aggregate cost of
documents. Clinically, an electronic plat-form also prevents errors such as entering a blood pressure incorrectly or performing a patient procedure out of order from the test protocol.
“We’re trying to convince the industry
Start-up Costs Can Be an Uphill Slog in Need of ChangeSeptember 2018 A CenterWatch Publication Volume 25, Issue 09
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This feature highlights changes in clinical trial organizations’ personnel.
Acesion PharmaAcesion Pharma has named Anders Holst its chief medical officer. Holst was senior in-ternational medical director at Novo Nordisk. Acesion has also recruited Birgitte Vestbjerg to take on the role of director of clinical op-erations. Vestbjerg was most recently director of clinical operations at MC2 Therapeutics.
AdvarraGadi Saarony has joined Advarra as the consulting company’s CEO. Saarony comes to Advarra from PAREXEL, where he served as executive vice president and chief CRS officer.
AiCureEd Ikeguchi, who previously served as chief medical officer and president of AiCure, has been named CEO of the company.
ANI PharmaceuticalsANI Pharmaceuticals has named Patrick D. Walsh interim president and CEO to fill the gap left by the retiring CEO, Arthur Przybyl. Walsh has served on ANI’s board of directors since 2018 and has extensive pharmaceuti-cal industry experience.
Antibe TherapeuticsAntibe Therapeutics appointed Joseph Stauffer to the role of chief medical officer. Stauffer previously served as chief medical officer of Inheris Biopharma.
Aurinia PharmaceuticalsJoe Miller has joined Aurinia Pharmaceu-ticals as its chief financial officer. Miller was previously the chief financial officer at Cerecor.
Cardiff Oncology (Trovagene)Cardiff Oncology, which recently changed its name from Trovagene, has appointed Mark
Erlander to lead the company as its CEO. Erlander had been Cardiff’s chief scientific officer since 2013.
CodexisCodexis has hired Stefan Lutz to the role of senior vice president of research. Most recently, Lutz was professor and chair of the chemistry department at Emory University. Karl Schoene was also tapped as Codexis’ senior vice president of devel-opment and operations. Schoene comes to Codexis from Elevance Renewable Sci-ences, where he served as president, CEO and director.
DEINOVEFrench biotech DEINOVE has named Alexis Rideau as its CEO. Most recently, Rideau was a strategic partnership manager and team coordinator for BIOASTER.
EmmesEmmes has named Joe Sliman chief medi-cal officer. Sliman joins Emmes from Social and Scientific Systems, where he served as senior medical director.
Endpoint ClinicalChristine Oliver has been appointed CEO of Endpoint Clinical. Oliver most recently served as chief operating officer of the company.
Enteris BioPharmaRajiv Khosla has been appointed to the role of CEO at Enteris BioPharma. Khosla joins Enteris from CEUTEC, a biopharmaceuti-cal and venture capital consulting firm he founded in 2011.
GalectoGalecto has appointed Jonathan Freve to the role of chief financial officer. Freve most recently served as chief financial officer and treasurer of Spring Bank Pharmaceuticals.
Gemini TherapeuticsMark Uknis has stepped into the chief medical officer role at Gemini Therapeutics. Uknis leaves a position as Achillion’s vice president and global nephrology develop-ment lead.
Goldfinch BioGoldfinch Bio has appointed Kyle Kuva-lanka to the role of chief financial and operating officer. Kuvalanka is a consul-tant at Third Rock Ventures and was chief operating officer at Syros Pharmaceuticals prior to this appointment. Goldfinch also announced the promotion of Lori Rudolph-Owen from senior vice president of R&D strategy and operations to chief development officer.
HORAMAGene therapy company HORAMA appointed Ian Catchpole to the role of chief scientific officer. Catchpole most recently served as director of research at TC BioPharm.
ICONICON has tapped Kristen Buck, former senior vice president and chief of clinical development at Optum, to join the CRO as its chief medical officer.
ImmunocoreBrian Di Donato has been named chief financial officer and head of strategy at Im-munocore. Previously, Di Donato was senior vice president and chief financial officer at Achillion Pharmaceuticals.
Impel NeuroPharmaImpel NeuroPharma has named Adrian Adams, current chairman of the company’s board of directors, as its CEO.
Intellia TherapeuticsDavid Lebwohl has been named chief medical officer of Intellia Therapeutics.
WCG | CWWeekly May 11, 2020 5 of 12
Up and Coming
continues on next page »
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Up and Coming (continued from page 5)
Lebwohl joins the company after an almost two-year stint as chief medical officer of Semma Therapeutics.
Johnson & JohnsonJohnson and Johnson promoted Najat Khan from the role of chief operating officer to chief data science officer.
Kezar Life SciencesNoreen Henig has been named chief medical officer of Kezar Life Sciences. Most recently, Henig was chief medical officer of Breath Therapeutics.
LifeMaxLifeMax has appointed Michael Huang to the role of chief medical officer. Huang was recently the chief medical officer of Spruce Biosciences.
Mirum PharmaceuticalsPeter Radovich has been named chief operating officer of Mirum Pharmaceuti-cals. Previously, Radovich was the execu-tive vice president of operations at Global Blood Therapeutics.
Myocardial SolutionsPeter Gaccione has joined Myocardial So-lutions as its president. Gaccione previously
served as executive vice president of North & Central America and president of Elekta.
New Jersey COVID-19 CommissionMerck CEO Ken Frazier has joined the New Jersey COVID-19 Restart and Recovery Commission, which will focus on guiding the state’s post-pandemic recovery strategy, as its chairman.
Nordic NanovectorMalene Brondberg, vice president of investor relations and corporation com-munications at Nordic Nanovector, has been appointed chief financial officer of the company.
Orchestra BioMedBob Laughner has been named vice president of regulatory affairs at Orches-tra BioMed. Prior to this appointment, Laughner was regulatory director of medical device and combination products for AstraZeneca.
PathoQuestLaurent Lafferrere has been named chief operating officer at PathoQuest. Lafferrere was most recently in charge of the SEQENS Lab R&D Center at SEQENS.
RespireRx PharmaceuticalsTimothy Jones has been named president and CEO of RespireRx Pharmaceuticals. Jones was most recently the vice president of global pharmaceuticals and medical OTC at Purisys.
Rome TherapeuticsRosana Kapelier will lead Rome Thera-peutics as its CEO following the company’s recent acquisition of $50 million in series A capital funding.
Signant HealthSignant Health has appointed Ian Jen-nings to the role of chief commercial officer. Jennings was most recently an indepen-dent consultant for clinical and healthcare technology companies.
TargovaxVictor Levitsky has assumed the role of chief scientific officer at Targovax. Levitsky was previously vice president and head of oncology research at Molecular Partners.
Tessa TherapeuticsTessa Therapeutics has announced the appointment of Jeffrey Buchalter to CEO. Buchalter joined Tessa in 2019 as an inde-pendent board director.
2020 Edition Available Now
Don’t let your clinical trials fail just because you don’t know the reporting rules.This new edition is a must-have, go-to guide for clinical trial compliance The Clinical Trials Adverse Event Reporting Guide covers more than 20 guidances from the FDA, HHS and the ICH and includes the text of all regulations pertaining to reporting adverse events in clinical trial.
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WCG | CWWeekly May 11, 2020 7 of 12
Features
Pandemic Is Expeditingcontinued from page 1
month on average, according to WCG Clini-cal’s Knowledge Base. But as the pandemic developed, the number of paused trials rose sharply to 26 for March and utterly skyrocketed in April, when 129 studies were placed on official hold.
Industry has also seen an extreme slowdown in enrollment as a result of the outbreak; only 11 percent of clinical research sites across 29 different countries said that they were open to enrollment as of May 1, Caruso said. A little more than a month be-fore, on March 24, 62 percent reported that they were open for enrollment — but just a week later, that number had plummeted to 26 percent and continued to drop afterward. Caruso noted, however, that she anticipates the number of trials open to enrollment will start to rise again in the near future.
Caruso referenced WCG Clinical data showing that with trial starts declining, the number of trials waiting to kick off have risen dramatically. Just in January, 629 new biopharma-sponsored studies were started, according to the data. That number declined to 546 in February, 492 in March, and de-scended sharply to 328 in April.
But the number of planned new trials skyrocketed from 223 in February to 463 in March and rose a tiny margin in April to 477.
Caruso pointed out that industry faces a collision of forces — a number of trials that are ongoing and soon to open to enrollment vs. a number of trials that are preparing to begin and will also open to enrollment.
“This is going to have tremendous impact as we come out of the COVID clinical trial landscape and turn to newer studies or ongoing studies,” she said. “The question re-ally becomes, what do we do when we have this collision of new trials that our sponsors definitely want to get ongoing and enrolling well, as well as the restarts for studies that have been delayed as a result of that pause in enrollment?”
She cited a survey taken by WCG Clinical that probed how long sites think it will be before they open to enrollment again. The survey, which questioned more than 1,250 sites, found that more than a third (37 percent) of sites were uncertain, 26 percent anticipated four to eight weeks, and 19 percent believed it would take two to four weeks. Seven percent said one to two weeks, while just two percent said it would take more than two months.
But as of last week, WCG Clinical found that 51 percent of sites across 29 different countries reported they will be open to enrollment and new study starts within two to four weeks, she said.
Caruso said that right now, sites should be supporting study coordinators as they’re forced to cover more than they’re used to during the pandemic.
“There’s going to be tremendous impact in the amount of resources that the study coordinators have to cover for their new studies and COVID work,” she said. “There are going to be COVID trials for a number of months, if not years. Providing clinical research coordinators for a study to be able to do data entry, to be able to do scheduling of patients and keeping track, I think is the best way to support our site colleagues, and I think that’s something a lot of sponsors are looking into in addition to remote assess-ments and remote visits.”
Tom Wardle, CEO of CenExel Clini-cal Research, who also spoke during the webinar, offered advice on adapting trials to the pandemic. Successfully doing so requires taking a strong educational approach toward participants, he said, advising sponsors to develop and put in place standard operating procedures (SOP) for participants and employees, including testing for the virus.
“The response needs to be a lot of education, a lot of training, both to clinic personnel as well as training to potential study participants, and then even more
importantly is demonstrating to study participants as they come in to potentially participate … that we’re showing them how seriously we are taking the precau-tions we need to take to try to minimize the risk of infection,” he said.
To minimize the risk of infection at a site, sponsors should develop a “formal pan-demic SOP” that includes the use of personal protective equipment (PPE), procedures for entering the facility, testing procedures and other measures.
“At our facilities, you basically don’t get through the front door, and that means vendors, employees, participants in stud-ies, without being screened in a kind of sequestered area,” he said. “You’re asking containment questions: have you been sick, where have you been, taking people’s temperature, asking about exposure to other individuals who may have had symp-toms in the recent past.”
Additionally, sponsors should reduce the number of participants and staff in specific site areas, scheduling subjects throughout the day to ensure there is no high traffic of subjects at any point in the day. Facility access should be strictly limited, with staff receiving daily screenings upon arrival, and space should be designated to isolate symptomatic patients at a moment’s notice. And while it may seem obvious, Wardle reminded sponsors that infection control and facility cleaning is an important part of reducing infection risk.
Wardle reinforced the importance of remotely monitoring patients and enabling remote visits, following current Centers for Disease Control guidelines for screen-ing employees and participants, and using COVID-19 polymerase chain reaction tests at screening, outpatient visits and inpatient unit entry. Patients and staff alike should be regularly reminded to continue the use of well-publicized guidelines for the coronavi-rus, such as the use of PPE, social distancing, hand sanitizer and other precautions.
© 2020 CenterWatch CWW2419
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Features
New ICH E6continued from page 1
reported they were 75 percent to 99 percent through adoption and 22 percent said they were 50 percent to 75 percent finished.
Top problems in adoption were identi-fied as risk-based management (27 percent of respondents), QTL implementation (21 percent), organizational change manage-ment and training (19 percent), policy and procedure updates (17 percent), and vendor oversight (16 percent).
“I believe that COVID-19 has really changed how rapidly the adoption of these technologies can be completed,” MacDonald said. “And this can help us adapt from E6(R2) to E6(R3).” The past few months of pandemic conditions have given the clinical trial indus-try new tools, resources and confidence in applying them, she added.
Technology and clinical trial design approaches have been undergoing rapid changes in the past few years, and the industry has been working to make technol-ogy part of trial execution and to increase efficiency. And the pace at which drug spon-sors and researchers adopted and adapted to new technologies and approaches increased exponentially when the existing site-focused system was challenged by COVID-19.
COVID-19 has changed the risk profile for many new technologies and study designs, MacDonald said. In essence, the risk-benefit profile of some approaches has undergone a “COVID shift” as industry was forced to adopt them to ensure some sort of business continuity.
“What used to seem too much a risk, too much unknown, is now required if you don’t want to stop your trial,” MacDonald said.
ICH released a concept paper that provides an outline of what drug sponsors and clinical investigators might expect from E6(R3). According to that paper, the guidance will be rewritten and reorganized with the primary objective of addressing the complexity of clinical trials in a global
regulatory environment; it will outline how GCP principles should apply to increasingly diverse trial types and data sources. The concept paper also indicates the new guid-ance will encourage flexibility whenever ap-propriate to facilitate incorporation of useful technological innovations and address specific complexities of clinical trials.
ICH E6(R3) will come out in two phases. The main guidance covering the overarch-ing principles and objectives is expected to come out sometime between May and December 2021. Accompanying it will be Annex 1, covering traditional interventional clinical trials. At that time, work on a second annex will begin. Annex 2 will cover non-traditional clinical trials, such as pragmatic and decentralized studies, as well as those incorporating real-world data (RWD).
Rapid technology development over the past decade, and even more so in just the past few years, is a primary driver behind the decision to update ICH E6 so quickly after the latest revision, according to the ICH concept paper.
That paper indicates that the new E6(R3) guidance will allow more rapid and flexible incorporation of new technologies into the clinical study and drug approval application process, said Steve Whittaker, senior consul-tant at The Avoca Group.
Historically, regulators have been reluc-tant to accept data generated by unfamiliar records and so the industry has been slow to adopt new technologies or study designs that might hinder their ability to get new products approved due to regulator discom-fort with how the data was generated.
A question is whether regulators — his-torically precedent-driven — can effectively accept and incorporate novel technologies. Whittaker suggested that the announcement of E6(R3) coming so soon after adoption of E6(R2) indicates that regulators recognize weaknesses in the traditional approach and are attempting to adapt. Industry’s rapid adaptations in the face of COVID-19 restric-
tions may also be helping regulators become more comfortable with — or at least more accepting of — faster technological change.
And that is a concern to drug spon-sors and researchers. According to the poll taken during the May 5 CenterWatch webinar, the most significant barrier to implementing new technologies within the clinical trial industry is uncertain regu-latory acceptance. The expense of new tech and unknown risk-benefit profiles are also seen as challenges.
Another driver behind the planned update has been the relatively rapid issuance of guidance by multiple international regula-tors on such key topics as risk-based quality management and monitoring, and quality by design (QbD). The November 2019 concept paper lists several documents ICH will con-sult as it drafts the new E6(R3), including:
} The existing ICH E6(R2);} Other ICH guidances, including E8 —
General for Clinical Trials, and ICH Q9 — Guideline on Quality Risk Management, which includes discussion of QbD;
} The FDA’s 2013 guidance on risk-based monitoring;
} A 2013 EMA reflection paper on risk-based quality management; and
} Three documents issued by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and Ministry of Health, Labor and Welfare (MHLW) in 2019 on GCP for drugs, quality man-agement in clinical trials and risk-based monitoring in clinical trials.
The industry can expect all of the fea-tures in E6(R2) to roll over into the upcoming new revision, Whittaker said. Some of the highlights include quality management and incorporation of QbD principles; although the latter were originally developed for GMP purposes, they are applicable to GCPs as well. Risk identification, evaluation and mini-mization — with emphasis on those risks that would affect patient safety and/or data integrity — will likewise remain a priority.
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Protocol design • Study design • Patient engagementGenetic testing & counseling
Together, we’re helping our partners deliver on the promise of precision medicine.
Genetics-oriented solutions to support clinical trials
The Center for Genetics and Precision Medicine in Clinical Trials
www.wcgclinical.com
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Drug & Device Pipeline News
Company Drug/Device Medical Condition Status Sponsor ContactCOVID-19 Trials and Actions
Organicell Regenerative Medicine
Organicell Flow moderate to severe acute respiratory syndrome (SARS) due to COVID-19 infection
IND approved by the FDA organicell.com
Global Institute of Stem Cell Therapy and Research (GIOSTAR)
mesenchymal stem cells
Covid-19 expanded access for compassionate use granted by the FDA
giostar.com
Eiger Biopharmaceuticals
peginterferon lambda
patients with mild COVID-19 first patient treated in phase 2 trial
eigerbio.com
Pulmotect PUL-042 prevention of infection with SARS-CoV-2 and the prevention of disease progression in patients with early COVID-19 disease
approval for two phase 2 trials granted by the FDA
pulmotect.com
Athersys MultiStem cell therapy
COVID-19 Induced Acute Respiratory Distress Syndrome (ARDS)
enrollment of first patients in phase 2/3 trial
athersys.com
Mesoblast remestemcel-L COVID-19-infected patients with moderate to severe ARDS on ventilator support
first patients dosed in phase 2/3 trial
mesoblast.com
Aridis Pharmaceuticals
AR-301 S. aureus induced pneumonia in COVID-19 patients on mechanical ventilators
enrollment of first patient in phase 3 trial
aridispharma.com
Gilead remdesivir COVID-19 Emergency Use Authorization (EUA) granted by the FDA
gilead.com
EUROIMMUN (a PerkinElmer company)
Anti-SARS-CoV-2 ELISA (IgG) serology test
detection of COVID-19 antibodies EUA granted by the FDA perkinelmer.com
Rheonix Rheonix COVID-19 MDx Assay
detection of SARS-CoV-2 EUA granted by the FDA rheonix.com
Roche Elecsys Anti-SARS-CoV-2 antibody test
detection of COVID-19 antibodies approved by the FDA roche.com
Other Trials and Actions
Bicycle Therapeutics BT5528 in combination with nivolumab
advanced solid tumors in indications associated with EphA2 expression
first patient dosed in phase 1 trial
bicycletherapeutics.com
Scholar Rock SRK-181 locally advanced or metastatic solid tumors
first patients dosed in phase 1 trial
scholarrock.com
Viriom VM1500A HIV-infected patients initiation of phase 2a trial viriom.com
Kubota Vision emixustat hydrochloride
macular atrophy secondary to Stargardt disease
completion of patient enrollment in phase 3 trial
kubotavision.com
Spero Therapeutics tebipenem HBr complicated urinary tract infection and acute pyelonephritis
completion of patient enrollment in phase 3 trial
sperotherapeutics.com
continues on next page »
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Drug & Device Pipeline News (continued from page 10)
Company Drug/Device Medical Condition Status Sponsor ContactAlume Biosciences ALM-488 peptide-dye conjugate for
fluorescence highlighting of nerves during head and neck surgery
IND approved by the FDA alumebiosciences.com
Green Valley Pharmaceutical
GV-971 Alzheimer’s disease IND approved by the FDA greenvalleypharma.com
Lipocine LPCN 1148 liver cirrhosis in adult male cirrhotic patients
IND approved by the FDA lipocine.com
Nanobiotix NBTXR3 patients with locally advanced or borderline resectable cases of pancreatic ductal adenocarcinoma
IND approved by the FDA nanobiotix.com
GeneTx Biotherapeutics
Ultragenyx Pharmaceuticals
GTX-102 Angelman syndrome Fast Track designation granted by the FDA
genetxbio.com
ultragenyx.com
Ascentage Pharma HQP1351 chronic myeloid leukemia Orphan Drug designation granted by the FDA
ascentagepharma.com
Seelos Therapeutics SLS-005 Sanfilippo syndrome Orphan Drug designation granted by the FDA
seelostherapeutics.com
AstraZeneca Farxiga (dapagliflozin)
adults with New York Heart Association's functional class II-IV heart failure with reduced ejection fraction
approved by the FDA for new indication
astrazeneca.com
Galderma Research Restylane Kysse lip augmentation and the correction of wrinkles around upper lips in adults over the age of 21
approved by the FDA galderma.com
Halozyme Therapeutics
Janssen Biotech
DARZALEX FASPRO (daratumumab hyaluronidase human- fihj)
multiple myeloma approved by the FDA halozyme.com
janssen.com
Novartis Tabrecta (capmatinib)
NSCLC tumors that have an abnormal mesenchymal-epithelial transition gene that leads to MET exon 14 skipping
approved by the FDA novartis.com
Tolmar Pharmaceuticals
FENSOLVI (leuprolide acetate)
pediatric patients two years of age and older with central precocious puberty
approved by the FDA tolmar.com
This new edition of The PI’s Guide is packed with information regarding your responsibilities including practical and ethical study conduct, site and financial management, and responsibilities imposed by ICH E6(R2).
ORDER TODAY
The PI’s Guide to Conducting Clinical ResearchConduct better, safer and more efficient clinical trials
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Research Center Spotlight
Research Center Spotlight is a monthly selection of clinical research centers who have Research Center Profile pages posted on CenterWatch.com. Included in their annual subscriptions, company profiles are randomly selected to appear in this section, providing added exposure for their expertise and services in conducting and managing clinical studies.
To learn more about becoming a Research Center Profile page subscriber, contact Sales at 617.948.5100 or [email protected].
Salt Lake City, [email protected]
J. Lewis is a unique research company with more than 28 years of experience conducting clinical trials for the pharmaceutical industry, specializing in phase 2-4 trials.
Palmetto Bay, [email protected]
The center was established in 2012 as a continuation of successful completion of more than 63 trials in previous research clinics. The research site is conveniently located in Palmetto Bay, an area easily accessible from South Miami and North Miami.
Chula Vista, [email protected]
Through comprehensive research services agreements with partner hospitals, eStudySite is able to conduct a broad range of in-patient and out-patient protocols spanning first-in-human/first-in-patient through pivotal trials and postmarket support.
Tucson, [email protected]
CNS is primarily involved with sponsored phase 2-4 clinical trials, but several of our investigators have developed and conducted investiga-tor-initiated studies and compassionate use trials. The clinic currently has a database of more than 67,000 active patients.
Hialeah, [email protected]
Direct Helpers Research Center is a dedicated medical institute that combines a network of committed and experienced personnel to conduct an array of clinical research trials in phases 1-4.
Bethesda, [email protected]
The NIH Clinical Center is part of the National Institutes of Health (NIH) in Bethesda, MD. It is the world’s largest biomedical research hospital and ambulatory care facility.
Ocala, [email protected]
Renstar’s research staff works with local physicians in private practice and community hospital set-tings to provide a multidisciplinary team focused on meeting enroll-ment goals while ensuring strict regulatory and protocol compliance.
New Hyde Park, [email protected]
A 527-bed institution located on the border of Long Island and New York City, Parker offers unique inpatient medical, subacute, nursing and rehabilitation programs complemented by an array of highly regarded community services.
Lancaster, [email protected]
MDFirst is committed to helping sponsors exceed their recruitment, quality assurance and data integrity goals. The center comprises of a network of physicians with extensive experience in conducting phase 2-4 trials of medications as well as devices.
Oklahoma City, [email protected]
OHHRF and its for-profit subsidiary, Oklahoma Cardiovascular Research Group, provide cardiovascular trial management services to pharma, medical device and biotech companies.
MDFirst Research
Oklahoma Heart Hospital Research Foundation
Center for Neurosciences
Direct Helpers Research Center
eStudySite
The NIH Clinical Center J. Lewis Research
Parker Jewish Institute
IMIC Renstar Medical Research
