Why do Funding and Legal Structure Matter in Decentralized Clinical Trials?

Optimizing clinical trial access for potential patients is a critical goal for researchers and sponsors. How can we make clinical research more accessible to anyone who wishes to participate? Decentralized clinical trials (DCTs) can meet that need, but they come with some challenges.

The concept of DCTs brings the trial activities to non-centralized places, closer to participants, so they have better access to the interventions and measures involved in conducting a trial. Ways to accomplish this include engaging home health groups to come to the participant’s home to collect or administer study tasks, or bringing interventions into the community by setting up a common place for interventions (e.g., collecting blood pressure at a barbershop). Utilizing remote technology is another way to aid in convenience and accessibility.

These activities provide more flexibility for participants. Designing a DCT comes with certain challenges of course, particularly when proposing to utilize outside groups or locations for the trial. Funding, sponsorship, tasks to be conducted, and the legal structures of entities may impact sites and the study overall.

Why do Funding and Sponsorship Matter?

Who sponsors a study and how the study is funded are key drivers for determining the trial’s regulatory oversight framework, as well as the framework used by the IRB to review it. This means the requirements will vary slightly depending on which entities fund the trial.

For example, consider a trial funded by a Department of Health and Human Services (DHHS) agency such as the National Institutes of Health (NIH). Trial activities and places where the trial is conducted must also have IRB review if they meet the definition of “engaged” in research under the DHHS/Office of Human Research Protections (OHRP) framework.

In contrast, if a study is sponsored by industry (e.g., a pharmaceutical company) and involves no federal funding or support, it would fall under the Food and Drug Administration’s (FDA’s) oversight—and the concept of “engaged” is not included the FDA framework. However, sites and individuals conducting the industry-sponsored trial could be required to be listed on the Form FDA 1572—if this is the case, those sites and individuals would be subject to the FDA regulatory framework which require IRB review of the activities.

The concept of “engaged” in research is not easy to decipher. It can be further complicated by the types of activities and determining if they “engage” a site in the research, or if the site or individual conducting the activity should be listed on the 1572.

How Does Legal Structure Impact the Decentralized Clinical Trial?

Another consideration to explore 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 it could make a difference in how trials are set up and conducted with respect to IRB oversight.

For example, an academic medical center (AMC) may employ its investigators as staff. Since investigators are employees of a larger entity, they may not have the authority to delegate trial oversight 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 be able to conduct their activities, such as a separate IRB review, either by the AMC’s local IRB or by a separate independent IRB.

There would have to be an agreement between the home health group and the hospital on which IRB (the AMC’s IRB or the home health group’s IRB) would review on behalf of and provide oversight for the home health group and their activities. It is important to know how your site is structured to be sure everyone can be covered in the most effective way in DCTs.

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