NIH All About Grants Podcast: Clinical Trials Reporting

David Kosub: What do you actually have to do to ensure that the results of your clinical trial are actually being reported? My name is David Kosub, and I am with NIH's All About Grants.

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David Kosub: Welcome to the show. I am glad to say that we have with us Deysi Duque. She is a Senior Clinical Trials Analyst with the Division of Human Subjects Research within the NIH Office of Extramural Research, my colleague. And I welcome you to the show.

Deysi Duque: Thank you, David. I'm glad to be here.

David Kosub: So, Deysi, just tell us briefly, what exactly is this clinical trials reporting policy, anyways?

Deysi Duque: Sure, so for those who are not familiar with the clinical trials reporting policy, we are referring about the policy on the dissemination of the clinical trial information, which requires all NIH-funded clinical trials to register and report clinical trial information into ClinicalTrials.gov. And by all clinical trials, we mean not just efficacy clinical trials but also pilot, feasibility, behavioral, exploratory, mechanistic and basic experimental studies with humans, known as BESH. And we also talk about all clinical trials, not just We're also referring to all clinical trials regardless of the intervention type and study phases.

David Kosub: Definitely a lot of different types of trials out there. What exactly is the purpose? Why does this policy even exist?

Deysi Duque: Great question, David. It is largely about transparency and broad dissemination of clinical trials information. It's important for science that the information about clinical trials that work and don't work be made public. And this goes beyond scientific journals and information accessible to scientists. We want information to be available to physicians, participants, and other members of the research community so that they find information in a consistent and concise way to know the work that has been done, what has worked and not and the approaches used to make this determination. We also want information to be available to patients and their families so they find information about clinical trials, as well. So the broad and timely dissemination of information is very important.

David Kosub: The broad and timely dissemination, I'd like to jump on that. What are we actually requiring our recipients and our applicants do to ensure that that information is broadly disseminated?

Deysi Duque: Sure. Well, first of all, we want to make sure that investigators proposing clinical trials provide a dissemination plan for their NIH application. So the plan is to describe how they plan to meet the policy expectations and how they plan to meet the required deadline. So It's important for them to plan accordingly to ensure that they register and report results information on time. After the study begins, we have to register their study into clinicaltrials.gov and no later than 21 days after the enrollment of the first participant. And then lastly, awardees need to provide their summary results into clinicaltrials.gov, and this is no later than 1 year after the clinical trial's primary completion date, so this is very important for them to know.

David Kosub: And kind of echoing a statement made earlier about efficacy trials, pilot studies, basic experimental studies on humans, there's all sort of trials, so I'm thinking about, what about applicable clinical trials, ACTs? Are they encompassed in this policy?

Deysi Duque: Absolutely, and this is actually a common misconception, and as I mentioned earlier, all clinical trials are required to meet the policy requirements, and not just ACTs, applicable clinical trials, are required to register and report results under FDAAA regulation and registration and reporting, although NIH clinical trials are part of the NIH award terms and conditions.

David Kosub: Are there any exemptions, exceptions rather, to this policy?

Deysi Duque: Right. There is a rare temporary exception given to a type of clinical trial that I mentioned earlier, as well. It's known as basic experimental studies with� humans, BESH, and they are allowed to register and report their summary reports into an alternate platform other than clinicaltrials.gov. And basically all other clinical trials, are required to use clinicaltrials.gov.

David Kosub: For those interested, �for basic experimental studies with humans, BESH, we do have a podcast on that, too, so you can definitely learn a little bit more about what those studies are all about. You mentioned exceptions, you know What about in situations where someone is just not complying with the policy? They're not doing what they're supposed to be doing. What kind of recourse does NIH have?

Deysi Duque: Sure. This is a very important question. Awardees do really need to comply with the policy requirements. NIH is tracking them and is also sending letters and notifications to institutions where studies are potentially noncompliant. So in addition, if a study is delayed in registration or reporting at the time of the progress report, the recipients will get notified from the system. And if this is the case, the award cannot be made until the requirements are met. So also, as the policy indicates, a failure to comply with the terms and conditions of the NIH award may result in enforcement actions, and this may include termination of the award. So this is really, really important, that applicants make sure that registration and reporting are done on time.

David Kosub: Yeah, I definitely echo that, that it's critically important. And I suspect we're not going to get every possible question answered in this conversation, so if What about situations? How do you, How can people go about asking questions and getting additional answers from us? What kind of resources are available to folks?

Deysi Duque: Yes, David, and we really have not talked about how to reach out for help. But NIH has different resources, and NIH has worked with recipients and investigators to ensure that they are aware of their requirements and the deadlines. We have done a lot of outreach to ensure that the community knows where to find information. So we have very helpful information on the extramural research web pages and some useful resources such as a decision tree as well as Open Mic blogs in the research nexus. For questions about the policy or the dissemination plan, they can always reach out to their institution's office of sponsored programs or reach out to their NIH program official that will be listed in the Notice of Funding Opportunity. If they also have policy questions or more general questions, they can reach out to one of our mailboxes, [email protected], and if they have more technical questions or questions about the clinicaltrials.gov platform, they can always reach out to register at clinicaltrials.gov.

David Kosub: Great. Thank you for all those resources. This has been a great opportunity to learn more about the policy of what we require for clinical trials reporting. Are there any final thoughts, anything you'd like to leave with the audience about this policy?

Deysi Duque: Yes, David. So I can't stress enough the importance of completing the requirements on time. This is truly a shared commitment to ensuring that information is disseminated broadly. And with the help of the research community, with getting together, provide transparency and accountability of the clinical trials system. So if you're an investigator, and you're approaching the deadline, please ensure that you either register or submit the results well ahead of the deadline and provide information to clinicaltrials.gov. Or if you receive a letter from NIH about a potentially noncompliant trial, please submit your registration results as quickly as possible. Also, if you're an institution leader, please emphasize to your investigators the importance of completing the requirements on time, and consider providing processes and creating internal controls to make this easier for the investigators to ensure that they provide the information more efficiently into clinicaltrials.gov.

David Kosub: A shared commitment, I like that and completely agree. We're all in this together to ensure all the results of our supported clinical trials are out there and available to people to find and to learn from. Well, Deysi, again, I appreciate this opportunity to learn more about the clinical trials policy from you. Again, I'll echo what she said. Reach out to your office of sponsored research. Check out the grants.nih.gov website. There's tons of information available there. Reach out to your program staff when appropriate. Ask questions. We definitely want to make sure that all of this is working for everyone. Again, this has been David Kosub with NIH's All About Grants. Thank you.

Deysi Duque: Thank you, David.