We have been talking a lot recently about NIH’s efforts to improve transparency and trust in NIH funded clinical trials. One important aspect of this effort is improving our ability to identify and describe the clinical trials we are supporting. In fact, a March 2016 GAO report GAO-16-304, entitled Additional Data Would Enhance the Stewardship of Clinical Trials across the Agency, highlighted the fact that “NIH is limited in its ability to make data-driven decisions regarding the use of its roughly $3 billion annual investment in clinical trials.” Many of the other aspects of this initiative, applying clinical trial specific review criteria, improving oversight, and registering and reporting in ClinicalTrials.gov depend upon our basic ability to identify and describe clinical trial applications and awards.
The new PHS Human Subject and Clinical Trial Information form will flag trials, helping us to achieve a number of goals. The form consolidates into a single location information on human subjects that is currently scattered across a number of forms. It allows us to capture structured and semi-structured descriptive information for each study included in a grant application or contract proposal, which will allow us to clearly identify which funded studies will require registration and timely reporting of results.
Each study record requires a minimum number of requested data elements. This starts with leading the applicant through the four questions that determine whether the study is considered by NIH to be a clinical trial. (See our August 11 post, 4 Questions for Researchers and Institutions Involved in Human Subjects Research for more on the NIH definition of a clinical trial.) The answers to those questions will determine whether or not the applicant will need to complete Section 4 of the form, the “Protocol Synopsis.” The form will help in peer review and will enable NIH to answer important questions, like how many clinical trial studies we are funding, the phase of those trials, and how many have as their primary purpose treatment evaluation or fundamental discovery.
Some information collected in this form is information that you likely would have included in the application elsewhere, either in the protection of human subjects attachment or in the research strategy. Now we are capturing that information in a structured format, which supports better monitoring of the studies by NIH staff after award. It also serves the purpose of leading the applicant or contractor through each of the elements we expect them to consider as they are planning for their grant application or contract proposal, which we expect will make for stronger applications. Collecting the protocol synopsis, study population characteristics, recruitments plans, and plans for statistical design and power in one place will also allow reviewers to more easily locate and evaluate these critical elements. For delayed onset studies, those studies for which the details are not known at the time of application, grantees will submit this information to NIH through the eRA Commons once it is known.
One question we are often asked is whether the information collected in the new form will be duplicative of the information provided in the research strategy. That is not our intent. The form allows you to spell out methodological details in the study record, allowing more space in the research strategy for higher-level descriptions and justifications of your experimental design(s) and methods.
A key element in the design of the form is that we were careful to be consistent with the data elements required for Clinicaltrials.gov reporting, which will help with data reuse and exchange between systems.
If you haven’t seen the new form, we have a 9 minute video that will guide you through and give you a good idea of how it works. The form will be included as part of the Forms-E application packages, which you will be required to use for all grant applications submitted for due dates on or after January 25, 2018. You will see the form associated with funding opportunity announcements as early as the very end of October/early November. We expect to make the PHS Human Subjects and Clinical Trial Information form available for Requests for Proposals for contracts posted as of January 25, 2018 as well. We recently published the instructions for FORMS-E (HTML/PDF) if you want to take an early look.