Designing Analyses by Sex or Gender, Race, and Ethnicity in NIH-defined Phase 3 Clinical Trials

NIH-defined phase 3 clinical trials are required to conduct and report analyses by sex or gender, race, and ethnicity for each primary outcome. These analyses, referred to as “valid analyses” are unbiased assessments that on average, yield the correct estimate of the difference in outcomes between two groups of participants.

New and Updated Resources Available to Help Design Rigorous Clinical Trials

We have embarked on a series of initiatives at NIH in recent years to enhance the quality, efficiency, accountability, and transparency of our supported clinical research. While we are all making great progress, our concerns about clinical trials that are overly complex, have small sample sizes, or rely on surrogate end points that lack clinical relevance remain. One resource to help address these concerns is the NIH Research Methods Resources website that NIH’s Office of Disease Prevention (ODP) launched in 2017. Since the site was recently revamped, we wanted to spotlight the new available tools and resources that can help you better plan the design, conduct, and analysis of rigorous NIH-defined clinical trials.

Guidance on Charging Personal Protective Equipment for Grants that Support Clinical Trials and Clinical Research

NIH has received many inquiries from recipients regarding their ability to direct charge personal protective equipment (PPE) costs to their clinical trials and clinical research awards. In this recent Guide Notice, NIH provides criteria for applicants/recipients on when it is appropriate to direct charge PPE costs.

A Walk-Through of the PHS Human Subjects & Clinical Trials Information Form

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.

Where to Post Informed Consent Forms for NIH-Funded Clinical Trials

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.

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.

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.

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 Subjects link in the RPPR.  The remaining fields (e.g. milestones) are not required to be … 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?”