The Benefits and Challenges of Decentralized Clinical Trials by Michele Russell-Einhorn and Julie Ozier

Many researchers and sponsors are continually looking for ways to optimize access to clinical trials for potential participants. That became even more apparent with the recent pandemic.  How can we make clinical research more accessible to anyone that wishes to participate? Decentralized clinical trials can meet that need, but they come with some challenges.

What are Decentralized Clinical Trials?
It’s all about access.
The concept of decentralized clinical trials means bringing the activities of the trial to non-centralized places, such as away from a doctor’s office or clinic, so that participants have better access to the interventions and measures needed to conduct a trial. 

A few ways researchers are decentralizing clinical trials include engaging home health groups to come to the home to collect or administer study tasks. One more way is by setting up a common place for interventions into the community such as (e.g., collecting blood pressure at a barbershop). A final way to engage is with utilization of remote technology. These activities provide more flexibility for clinical trial participants while aiding in convenience and accessibility.

Decentralizing clinical trials is not without challenges!
Funding, sponsorship, legal structures should be considered
However, there are some challenges that should be considered when designing a decentralized clinical trial when proposing to utilize outside groups or places for the trial. For example, funding, sponsorship, tasks to be conducted, and the legal structures of entities are all considerations to be taken into account when a DCT includes additional people and places.

Why does funding and sponsorship matter?
Funding, as well as who sponsors a study, are key drivers for which regulatory framework has oversight of the trial and what framework is used by the IRB to review it. This means the requirements vary slightly when different entities fund the trial. For example, if a clinical trial is funded by a DHHS agency such as NIH, activities, and places where the trials are conducted must also have IRB review if they meet the definition of “engaged” in research under the DHHS/OHRP framework. In contrast, if a study is sponsored by Industry and involves no federal funding or support, the concept of “engaged” is not in the FDA framework. However, sites and individuals conducting the trial could be required to list on the 1572. If they are that subjects those trials to the regulatory requirements under the FDA framework and requires IRB review of the activities. It is not easy to decipher when it’s required and can get further complicated by the types of activities needed during the clinical trial.  Determining if they “engage” a site in the research or if the site or individual conducting the activity should be listed on the 1572 is a difficult decision.

Another consideration that might need exploration is the legal structure of the site, sponsoring site, or entity where the research occurs and who can provide oversight. This concept is a bit more nuanced but could make a difference in how trials are set up and conducted with respect to IRB oversight. For example, an academic medical center or independent hospital may employ its Investigators as staff. Since Investigators are employees of a larger entity, they may not have the authority to delegate oversight of a trial to another entity, such as a home health group. If the home health group is conducting research activities, they would need some authority or oversight to conduct their activities, such as a separate IRB review. There would have to be an agreement between the home health group and the hospital on which IRB would review on behalf of and provide oversight for the home health group and their activities.  It’s important to know how your site is structured so that everyone is effectively covered in Decentralized Clinical Trials.

For more information on Decentralized Clinical Trials
These trials seem to be the wave of the future and have many advantages for participants. For more information on this topic register for PRIM&R 2022 Annual Conference session, PRIM&R Service Award Presentation, and Plenary IX: Decentralized Clinical Trials (DCTs): Considerations of and for IRB review (Location: Livestreamed) Thursday, December 15, 2022, 10 AM – 11:30 AM.

Session Description
DCTs may increase enrollment both by lessening the burden of participation and by increasing the geographical footprint of recruitment (including both underserved urban and rural areas), although barriers to implementation exist. Among these barriers is the relative lack of familiarity with the ethical issues presented by DCTs, particularly given their wide variation in study design, conduct, and scope that, in turn, present difficulties for IRB review and approval. These issues include electronic informed consent, tele- and/or video-medicine and home health visits, investigational drug delivery, remote monitoring, digital data collection, data transfer, data sharing, privacy, confidentiality, participant data literacy and access, and others. The recommendations for IRB review by a multi-disciplinary group of clinical trial stakeholders (e.g., IRB professionals, academia, technology companies, patients, pharmaceutical sponsors) will be presented and discussed.

Michele Russell-Einhorn, JD is the Chief Compliance Officer and Institutional Official for Advarra, a research compliance company with IRB Services, IBC Services, consulting and technology solutions for clinical research. Her expertise is in the areas of protection of human subjects in research, scientific review of cancer research and research administration generally.

Previously, she was the Vice President for Human Research Protections at Schulman IRB and prior to that she served for 11 years as the Senior Director, Office for Human Research Studies at the Dana-Farber Cancer Institute where she was responsible for the management and support of scientific review and institutional review board review, as well as other regulatory matters, involving all cancer relevant research involving human subjects conducted at the five Harvard clinical institutions under the umbrella of the Dana-Farber/Harvard Cancer Center.

She has over 30 years of professional experience including service as the Conflicts of Interest Attorney for the National Institutes of Health; Director of Regulatory Affairs for the U.S.D.H.H.S Office for the Protection from Research Risks (OPRR) and its successor office, the Office for Human Research Subjects (OHRP); Director in the Global Pharmaceuticals Practice at PWC; as well as the Associate General Counsel for the J. Craig Venter Institute.

She is a co-chair of the U.S.D.H.H.S. Secretary’s Advisory Committee on Human Research Protections, Subcommittee on Subpart A; as well as a founder of the IRB Directors Group of the National Comprehensive Cancer Center. She served as the Co-Chair for three years and a core planning committee member for five years of the annual Ethics in Research Conference sponsored by Public Responsibility in Medicine and Research. More recently, she helped to initiate and run the new AAHRPP collaborative network. She is a speaker at numerous conferences on various topics relating to research involving human subject protections, bio-repositories and FDA regulations.

Julie Ozier -Photo by Joe Howell

Julie Ozier has been in the human research protections and research compliance area for over 20 years. She was one of the founders of IRBshare which in its current form, is IRB Reliance Exchange (IREx). She also developed best practices for implementing single IRB for the Trial Innovation Network in response to the NIH and Common Rule mandates. She is currently the Senior Vice President for IRB Review at Advarra.  Previously, she was the Director of the Human Research Protections Program at Vanderbilt University and Medical Center. She has a Master’s in Health Law and is a Certified IRB Professional (CIP) as well as Certified in Healthcare Research Compliance (CHRC).  She served as a Site Visitor and a Council Member for the Association for the Accreditation of Human Research Protections Programs (AAHRPP) for several years and is active in the HRPP community.