The Behavioral and Social Clinical Trials Template: A New Resource!

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: https://osp.od.nih.gov/rfc-behavioral-social-sciences-studies/. 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.

William Riley
Director of the NIH Office of Behavioral and Social Sciences Research

Improving Visibility of NIH-Supported Clinical Trial Activities and Results Information

In a separate post today, we provide an overview of the various reforms the NIH is leading to enhance our stewardship of clinical trials. In this post we’d like to focus a bit more on our efforts to broadly disseminate clinical trial availability and results information.

Timely dissemination of clinical trial results information has been a problem, one that has been documented more than once, and that appears to apply to NIH- as well as non-NIH funded trials. To realize the benefits of a clinical trial, the findings must be available to the public as soon as possible after the trial has concluded. This is not only responsible use of taxpayer dollars for publicly funded trials, but also fulfills our responsibility to the individuals who volunteered in these studies with an understanding that their participation would contribute to advancing medical knowledge. Today, NIH announced a new policy that will complement a new federal regulation, referred to here as the Final Rule, also released today, to improve the accessibility of information on clinical trial availability and on the outcomes and results of completed trials.

As you likely know, to carry out the laws passed by Congress, federal agencies issue regulations that govern the activities of the agency and the applicable community. The “Final Rule” announced today by the U.S. Department of Health and Human Services is the federal regulation that implements requirements in the Food and Drug Administration Amendments Act of 2007 (FDAAA) for registering and reporting clinical trials on ClinicalTrials.gov. Clinical trials that are subject to this federal regulation are, in general, trials of drug, biological, and device products regulated by the Food and Drug Administration (FDA), except phase 1 trials of drug and biological products and small feasibility studies of device products. Pediatric post-market surveillances of device products, required by the FDA, are also subject to the regulation.

In addition, NIH issued a policy today that complements the Final Rule and sets the same reporting expectations for all NIH-funded clinical trials whether or not they are subject to the regulation (to include, for example, phase 1 studies of FDA regulated products as well as studies of interventions not regulated by FDA, e.g., behavioral interventions.)Both the NIH policy and the Final Rule will take effect January 18, 2017.

The Final Rule and NIH policy will provide greater clarity and robust enforcement provisions that we anticipate will result in rapid increases in the percentage of trials that are registered and that will promote timely dissemination of main results information through ClinicalTrials.gov. Investigators and sponsors who fail to comply with the regulation will be subject to civil monetary penalties assessed by FDA. In addition, NIH will restrict clinical trial funding to grantee institutions if the agency is unable to verify adequate registration and results information reporting from all trials funded at that institution. Failure to comply with the NIH policy in accordance with the terms and conditions of an NIH award can also have consequences, including suspension of funding.

In addition to the Final Rule and NIH policy, NIH has made available a number of resources to help explain the changes, and will be rolling out more over the upcoming months. Resources available now include:

As described in the NIH Guide Notice, for the NIH extramural program, the NIH policy applies to applications for funding including for grants, other transactions, and contracts submitted on or after the policy’s effective date that request support for the conduct of a clinical trial that is initiated on or after the policy’s effective date. For the NIH intramural program, the NIH policy applies to clinical trials initiated on or after the policy’s effective date.

Any grant application or contract proposal submitted on or after the policy’s effective date (January 18, 2017) must include a plan describing how awardees will ensure the appropriate dissemination of NIH-funded clinical trial information. The contents of this plan may vary, depending on whether the NIH clinical trial falls under the Final Rule (referred to as an “applicable clinical trial”), and whether the awardee or investigator is a “responsible party” as defined in the Final Rule (42 CFR Part 11). For more details, please read the NIH Policy on Dissemination of NIH-Funded Clinical Trial Information and the Final Rule published today.

We certainly encourage the broad dissemination of results information from all trials, both through ClinicalTrials.gov and peer-reviewed published results, even prior to the NIH policy’s effective date. Please join us in our efforts to maximize the federal investment in clinical trials as well as maximizing the impact of the contributions of the patient volunteers who are so critical to helping advance human health as a whole.

Dr. Mike Lauer is the NIH Deputy Director for Extramural Research and blogs about NIH research funding policies and data at his blog, Open Mike.

Dr. Mike Lauer
NIH Deputy Director for Extramural Research
Carrie D. Wolinetz, PhD
Former Associate Director for Science Policy, NIH