Search Results for: "clinical trials"

Building Better Clinical Trials through Stewardship and Transparency

NIH is the largest public funder of clinical trials in the United States. As stewards of this research enterprise, we have been actively listening and discussing how to overcome hurdles and shortcomings that we, and others in the research community, have identified. If you’ve been following the conversation, you’ll know that NIH already has implemented some key reforms to enhance clinical trial stewardship. Today, in a Viewpoint Essay published in the Journal of the American Medical Association (JAMA), we provide an overview of how these reforms, and new initiatives, fit in to the broader picture of building a better clinical trial enterprise through better stewardship, accountability, and transparency.

Figure 1 illustrates the clinical trial “lifespan”, and key opportunities for improving the quality and efficiency of clinical trials – opportunities that translate into more innovative and robust clinical trial design, and accelerated discoveries that will advance human health. NIH is leading a multi-faceted effort that addresses shortcomings and challenges throughout this lifespan, including the application and award process; the scientific review of trial applications; post-award management and oversight; sharing of trial data; and dissemination of research results information to the public. ….

A Proposed HHS Regulation and NIH Policy to Further the Impact of Clinical Trials Research

Clinical trials play a vital role in transforming scientific research into medical interventions to improve human health. Transparency about the clinical trials underway and their subsequent results ensure potential participants can make informed decisions about potential trial participation and know how their participation may have helped others. …. Today, the Department of Health and Human Services (HHS) announced proposed regulations to implement the clinical trial reporting requirements established by the Food and Drug Administration Amendments Act (FDAAA) of 2007. …. Importantly, today NIH also announced a proposal to apply these same proposed requirements to all NIH-funded clinical trials, whether subject to FDAAA or not. The proposed policy would require that every NIH-funded clinical trial be registered ….

Tool Tip: Human Subjects System (HSS) Quick Guide for Warnings and Errors 

Have you encountered warnings or errors when working in the Human Subjects System (HSS)? Not to worry, a guide is now available to help Principal Investigators and Signing Officials who enter data into HSS resolve common warnings and errors

ClinicalTrials.gov is Modernizing to Serve You Better

In June 2023, we will reach an important milestone: replacing the current website with the modernized ClinicalTrials.gov website. This modernized site will implement the innovations we have designed based on user feedback, including an updated look and feel and improved functionality for searching, viewing, and downloading information about clinical trials.

New Resources Available on Submitting Good Cause Extension Requests for Results Reporting to ClinicalTrials.gov

Do you have questions about when it’s allowable to request an extension of the deadline for submitting clinical trial results information to ClinicalTrials.gov, how to request an extension, what to include, and how the requests are evaluated? A recently published resource explains all this and more.

Your Questions on Human Subjects Research, Answered

If you’re conducting research with human subjects, you might have questions about HHS regulations and NIH policies and how you can prepare proposals and inclusion plans. HHS and NIH experts address many of these questions, along with resources, guidance, and case studies in a 2-part webinar series focused on Human Subjects Research Policies, Clinical Trials, and Inclusion.