We’ve updated the Walk-through of the PHS Human Subjects & Clinical Trials Information Form video to align with our latest application form update (FORMS-F). In just six minutes, you’ll learn how to use the form and how to complete both delayed onset and full study records.
For details on expanded flexibilities, such as mid-project period extensions and administrative supplements for unanticipated costs, see NOT-OD-20-087.
NIH’s National Library of Medicine has launched an effort to modernize ClinicalTrials.gov to deliver an improved user experience on an updated platform that will accommodate growth and enhance efficiency. Creating a roadmap for modernization requires feedback from a wide array of stakeholders on how to continue serving, balancing, and prioritizing their varied information needs. As ClinicalTrials.gov celebrates its 20th anniversary on February 29, 2020, we’re asking for your input on how it can best continue to serve your needs for many more years to come.
Continuing to Work with the Community on Registration and Results Reporting for Basic Experimental Studies involving Humans
Basic research involving humans that seeks to understand the fundamental aspects of phenomena also may meet the NIH-definition of a clinical trial. We refer to these studies as BESH – Basic Experimental Studies involving Humans (see our previous blog). Since this type of research meets the NIH definition However, some researchers have faced challenges in fitting these studies into the data fields for submission in ClinicalTrials.gov. The NIH has determined that more time is needed to address these challenges. Today, NIH published a Guide Notice (NOT-OD-19-126) announcing the extension of delayed enforcement of registering and results reporting of BESH on ClinicalTrials.gov through September 24, 2021.
The revised Common Rule requires that an IRB-approved version of an informed consent form be posted on a public federal website for all NIH-funded clinical trials. This must be done after enrollment ends and within 60 days of the last study visit. See Guide Notice NOT-OD-19-050.
A new Behavioral and Social Sciences Research Template is now available to guide investigators through the systematic development of a comprehensive clinical protocol. The new template, based on the previously released Phase 2 & 3 Clinical Trial Template, is fully integrated into the NIH’s Clinical e-Protocol Writing Tool, and can be used by behavioral and social science researchers to prepare research protocols for human studies measuring a behavioral or social outcome, or testing a behavioral or social science based intervention. This template may be especially helpful to investigators who are less familiar with the information and the level of detail that is required in a clinical protocol.
When conducting clinical trials, NIH funding recipients are required to register their study at ClinicalTrials.gov. To make registration easier, a new feature in the eRA Human Subjects System (HSS) allows applicants and recipients to export study record entries as an XML file, and upload fields that are captured in both systems directly into ClinicalTrials.gov’s Protocol Registration and Results System (PRS).
We Want Your Feedback About Results Reporting for Basic Science Studies Involving Human Participants
We have written several blogs and articles over the past two years about our efforts to enhance stewardship and transparency in clinical trial research. Indeed, earlier this year Congress applauded our efforts thus far and reaffirmed its commitment to ensuring public access to the results of the NIH-funded clinical trials through timely registration and results information reporting on ClinicalTrials.gov. However, we have heard concern about how the NIH’s Policy on the Dissemination of NIH-Funded Clinical Trial Information applies to fundamental studies involving human participants.
The NCATS Trial Innovation Network – A Resource Supporting High Quality and Cost Effective Clinical Trials Available to You
Well-conducted randomized trials are considered the best method of providing evidence about the safety and efficacy of treatments to improve health. Each year, NIH Institutes and Centers spend an estimated $3-4 billion supporting clinical trial activities. These activities require high-level understanding of human biology, of manufacturing and pre-clinical research, and of regulatory requirements. The process of translating a new therapeutic from discovery to practice can be robust, but … at the same time is long and expensive – and despite the challenges inherent in complex, multi-disciplinary research sometimes too long and too expensive.
Open Mike Perspective: Healthy Skepticism when Focusing Solely on Surrogate Endpoints in Clinical Research
I recently wrote an essay for the NIH’s Science, Health, and Public Trust series to encourage a healthy bit of skepticism about clinical studies that solely involve surrogate end-points (e.g. changes in “biomarkers” like blood cholesterol levels or findings on an electrocardiogram).