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.
- Good Clinical Practice (GCP) Training. Please remember that as of January 1, 2017 NIH expects investigators involved in NIH-supported clinical trials, and staff who design, oversee, manage, or conduct clinical trials, to receive training in GCP. NIH does not expect training to be completed by this date; rather, as long as steps are being taken to meet the training expectation, the training can be completed after the effective date. Note that NIH does not specify a particular GCP training; there are many free and fee-based courses available. If you are interested, free courses are offered by NIAID and NIDA, or, if you are looking for one geared to social and behavioral research, you might be interested in the training offered by NCATS. If you have considerable clinical trial experience, many GCP training courses offer an optional pre-test. A high enough score on the pre-test allows you to immediately earn a certificate of completion. Additional information may be found in the new GCP training FAQs.
- Enhancing Clinical Trial Registration and Summary Results Information. Also remember that for all grant applications and contract proposals submitted on or after January 18, 2017, NIH expects that investigators conducting clinical trials (funded in whole or in part by the NIH) will ensure that these trials are registered at ClinicalTrials.gov within 21 days of first-patient enrollment and that the results information from these trials is submitted to ClinicalTrials.gov within one year of trial completion. NIH’s policy complements a new federal regulation to improve the accessibility of information on clinical trial availability and on the outcomes and results of completed trials. Today, we published a new set of FAQs on this topic, to help you.
- Use of a Single Institutional Review Board (sIRB) for Multi-site Studies. We have been gratified to hear that institutions have been working through the issues related to implementing the sIRB policy for NIH funded multi-site studies. We recently issued a notice extending the effective date of the sIRB policy from May 25, 2017 to September 25, 2017 to ensure institutions have enough time to plan. We also published sIRB implementation FAQs to address questions you may have, and will continue to update and add to this new resource.
Work continues on updating a clinical trial protocol template, on developing ways to capture clinical trial information in the most useful way in the application, on developing funding opportunity announcement language, and more. We’ll be sure to keep you updated every step of the way.