Speaker
Adrian Hernandez, MD, MHS
Director, Duke Clinical Research Institute
Pamela Tenaerts, MD, MPH
Chief Scientific Officer, Medable
Craig Lipset, MPH
Co-Chair, Decentralized Trials & Research Alliance
Keywords
Decentralized; Guidance; FDA; Clinical trials
Key Points
- Decentralized clinical trials (DCTs) are regular clinical trials in which all activities take place at locations other than traditional trial sites. Over the past several years, a variety of factors have accelerated the need for decentralized trials, including the push to make trials more accessible, the increased speed of science, the possibility of environmentally conscious trials, and the need to be flexible in a rapidly changing world.
- During the COVID-19 pandemic, several regulatory authorities around the world introduced guidance on DCTs. There has been a growing sense of hesitancy about whether regulators will remain equally receptive to these decentralized methods when the pandemic recedes. The Food and Drug Administration (FDA) issued a draft guidance in May 2023 that provided guidance about the conduct of decentralized clinical trials. This guidance and others in development in other markets act as an important countermeasure to ensuring sustained adoption and implementation of DCTs.
- The FDA draft guidance includes guidance around rules and expectations for topics, including patient safety and data integrity, location stipulations, rules for health care providers, telehealth versus in-person protocol, digital health technology, trial operations, management and supervision, consent, and investigational product (IP) administration. Additional considerations are needed for the data management plan, monitoring plan, safety plan, task log, and case report forms in the FDA draft guidance.
- The European Medicines Agency (EMA) released a separate guidance around DCTs in December 2022. While similar to the FDA draft guidance, the EMA guidance differs slightly in its emphasis and lack of certain topics. For instance, there is no discussion of the role of the health care provider in the DCTs, but it emphasizes the importance of patient voice. The EMA guidance also features an extensive discussion on the need for investigator oversight.
- The key remaining issues for DCTs include clarification around the roles and responsibilities of health care providers as well as principal investigator (PI) oversight and responsibility. All trials are different, but it’s important to ask the right questions and be clear in the protocol.
- As IRBs and ethics committees review of DCTs, they can use newly developed recommendations for what should be submitted and discussions that should occur once the appropriate documents are submitted.
- DCTs are not only more convenient for trial participants, but they often provide a positive return on investment for the trial itself. The DCT space is evolving and will require more commentary on guidance, sharing research, and effective implementation.
Learn more
Read more about Decentralized Clinical Trials.
Discussion Themes
-As an early adopter of DCTs, could you share your experience and perspective on these issues? DCTs can make things easier for patients and the research more efficient. It can also contribute to providing more inclusive trials in solving some of the access issues that exist in healthcare and clinical trials. There are a lot of gray areas within the FDA guidance, but the key is to work together to address these challenges and ambiguities in order to ensure the safety and needs of the patients, while generating the knowledge necessary to further the trials.
-What is your response to questions surrounding the issue of adverse event reporting issue? A lot of questions on this topic have to do with the role of the health care provider as it relates to event reporting. The idea that health care providers in our communities may have data about an adverse event is not necessarily new, and health care providers are often aware of an adverse event very early on. Interstate licensing and our own institution’s policies are issues that still need to be addressed in terms of oversight and responsibilities. In some ways, health care providers are the same as any other data instrument in the trial – they are external data sources that come back to the investigator for safety and quality review.
Tags
#pctGR, @Collaboratory1