In May 2017, NIH and FDA released the final version of a template document aimed at assisting NIH-funded investigators in preparing Phase 2 and 3 IND/IDE clinical trial protocols. Additionally, at that time, NIH also released the electronic Protocol Writing Tool (e-Protocol Tool) which was based on the NIH-FDA protocol template. The way we like to describe the e-Protocol Tool is that it is like a Turbo TaxTM for developing clinical trial protocols. We think it can be safely said that both of these products have been an unmitigated success! In fact, the e-Protocol Writing Tool is one of the most frequently visited pages of the OSP website, drawing on average over 1,000 visitors per month.
Almost immediately, we began to think of how NIH could leverage this platform and expand to other clinical research areas that do not involve a drug or medical device intervention. Taking into consideration the recent NIH policies that have expanded the requirements of clinical trials beyond those that are FDA-regulated, it seemed most appropriate to develop a template specifically aimed at studies involving social and behavioral interventions. Most NIH Institutes and Centers (ICs) fund behavioral and social science clinical trials, so it makes perfect sense to have a resource available that aims to help investigators conducting these types of trials.
Today, the NIH released a request for public comments on the Draft Behavioral and Social Clinical Trials Template. This template was created to guide investigators through the systematic development of a comprehensive clinical protocol. The template will be especially helpful to investigators who are less familiar with the information and the level of detail that is required in a clinical protocol. The template retains much of the content and structure of the NIH-FDA Phase 2 and 3 IND/IDE clinical trial protocol template but has been tailored specifically for studies involving a social or behavioral intervention. Given the variations of intervention approaches and designs in the behavioral and social sciences, the NIH wants to encourage comments from a broad and diverse range of investigators on this draft protocol template.
It is important to note that the NIH Clinical Trials policies do not require the use of these protocol templates when submitting a protocol to clinicaltrials.gov or to the NIH Institute that funds the project and provides oversight. For basic or mechanistic studies subject to the clinical trials policies, some components of the template may not be applicable. However, use of the template will help ensure that investigators are writing a protocol consistent with the guidelines outlined in the International Council on Harmonisation (ICH) E6 Guidelines for Good Clinical Practice, which are intended to ensure research integrity and the protection of human research participants.
Comments on the draft protocol template can be made by visiting: Previously Compiled Public Comments. While members of the public are free to comment on any aspect of the template, we are most interested in comments about its utility and the clarity of the instructional text. Comments on the template will be accepted until October 11, 2018.
We have also saved the best news for last. Once NIH has considered all of the comments we receive, we will then integrate the final behavioral and social sciences protocol template into the existing e-Protocol Writing Tool! Investigators will then have a true one-stop (electronic) shop for all of their needs when it comes to preparing Phase 2 and 3 IND/IDE clinical trials documents and comparable behavioral/social science clinical trials.
Please help make the draft behavioral and social clinical trials template the best it can be by reviewing and providing your feedback!
This blog was co-authored by Dr. William Riley, Director of the NIH Office of Behavioral and Social Sciences Research (OBSSR). More information about OBSSR can be found at https://obssr.od.nih.gov.
It’s wonderful that this revision of the NIH Clinical Trial Template has been forwarded, to specifically include behavioral and social interventions.
The document is very specific, which is helpful; the explanatory language (e.g., objectives and endpoints) is user-friendly.
The “Administration of questionnaires or other instruments for patient-reported outcomes, such as a daily diary” section seems rather basic. Verbal report instruments can be administered on paper, or via question-asking by an investigator. These same approaches can be administered to significant others (e.g., spouses) or to health professionals providing care to the research participant. Furthermore, structured and semi-structured interviews also can be administered pre and post intervention, and so might be specifically mentioned as well.
In the future, it would be very helpful to have a sample completed protocol available online that would provide a “real life” example of a behavioral or social science intervention.