The Roles of Fellows and Trainees in NIH Supported Clinical Trials

NIH encourages fellows supported on NIH NRSA Fellowship awards and trainees supported on NIH NRSA Training awards to receive training in clinical research, including in the conduct of clinical trials. Under a mentor’s guidance, fellows and trainees can gain experience in the wide variety of research skills specific to clinical trials including, but not limited to: developing a clinical trial protocol; applying the principles of informed consent and requirements for human subjects research; learning about random assignment of participants to different intervention arms; analyzing trial endpoints; and/or implementing quality control standards. Continue reading

Are Studies Ancillary to Clinical Trials Considered to be Clinical Trials As Well?

It depends. Yes; if the ancillary study adds an additional prospectively assigned intervention to patients or a sub-population of patients within the larger clinical trial and all elements of the NIH clinical trial definition are met. No; if the ancillary study is only adding additional measures to an existing clinical trial. Continue reading

In the RPPR, do we need to fill out the Human Subjects and Clinical Trials Information form if we submitted a competing application before January 25, 2018?

The Human Subjects and Clinical Trials Information form appears for all recipients with human subjects studies. However, those who submitted competing applications for due dates on or before January 25, 2018 only need to update inclusion data via the Human … Continue reading

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. Continue reading

New Video Provides Overview of New NIH Policies on Human Subjects Research and Clinical Trials

Do you do research with human participants? If so, you play an important role in NIH initiatives to improve accountability and transparency in the human subject research we fund. This 15 minute video Overview of New NIH Policies on Human Subjects Research and Clinical Trials provides a succinct explanation of the various policy changes and what they mean for you. Continue reading

Spreading the Word About Policies Impacting Human Subjects Research and Clinical Trials

Understanding the impact of the new human subject and clinical trial policies on selecting a funding opportunity announcement, developing an application, the review of applications, and reporting on grant awards will be critical in the upcoming months. …. we have made a variety of resources available to the research community to assist with institutional training and outreach….. Continue reading

Status of Our Initiatives to Strengthen Clinical Trials

In September Dr. Carrie Wolinetz and I blogged about our policy reforms to build a more robust clinical trials enterprise through greater stewardship and transparency at each phase of the clinical trial journey from conception to sharing of results. We discussed how these efforts promise to improve the quality and efficiency of clinical trials, translating into more innovative and robust clinical trial design, and accelerated discoveries that will advance human health.

Over the past months we have continued to partner with the community to work through the implementation of these new policies, developing responses to frequently asked questions and even reconsidering the timing of our single IRB policy to give our grantees time to work through how to operationalize the change. …. Continue reading

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. …. Continue reading