As reported in the Sept. 30th CCTS Digest, several federal agencies with oversight of clinical trials, including the National Institutes of Health (NIH), the U.S. Department for Health and Human Services (HHS), and the Food and Drug Administration (FDA), have announced new regulatory requirements that will impact nearly every stage of the clinical trial lifespan. The overarching goal, as described by NIH leaders in the Journal of the American Medical Association, is “to elevate the entire biomedical research enterprise to a new level of transparency and accountability” and so “help NIH better fulfill its mission of supporting scientific discovery to improve human health.”
Below we review the first two requirements to take effect in 2017. These represent just the beginning of a wave of clinical trial policy changes coming in the new year. The CCTS is working hard to provide numerous supports to help investigators, their teams, and the institutions they represent meet the challenges posed by the federal government’s intense effort to maintain the public trust by increasing the efficiency, accountability, and transparency in clinical research. Current and future resources offered by CCTS are highlighted below as well.
Good Clinical Practice Requirement
The earliest change takes place on January 1, 2017, by which date all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials must be able to document training in Good Clinical Practice (GCP). The requirement (NOT-OD-16-148) also states GCP training must be renewed every three years. The aim is “to help ensure that all involved in the clinical trial enterprise have the appropriate knowledge about the design, conduct, monitoring, recording, analysis, and reporting of clinical trials.” NIH considers GCP training a “crucial first step” in the clinical trial reform process.
ClinicalTrials.gov Registration and Reporting Requirement
The second change will take place on January 18, 2017, when the Protocol Registration and Results System (PRS) of ClinicalTrials.gov will be ready to support the new NIH policy requiring clinical trial registration within 21 days of enrollment of the first participant. “Investigators will need to be prepared to upload their entire protocol and a statistical analysis plan,” says Penny Jester, director of the CCTS Clinical Research Support Program (CRSP). The new policy covers all NIH-funded trials, including those not subject to the DHHS Final Rule regulation, such as phase 1 studies or clinical trials of behavioral interventions or non-FDA-regulated products.
By this date the PRS will also be able to support the HHS Final Rule, which requires the reporting of summary results within 12 months after the date of final data collection for prespecified primary outcome measures. The NIH has announced stiff penalties for those who do not adhere to the requirements for registering and reporting, including the loss of federal funding and fines, as much as $10,000 a day. As noted by the New England Journal of Medicine Special Report, “the days of deciding whether or not summary results are worth reporting are over.”
CCTS Supports for Clinical Investigators and their Teams
CCTS Director Dr. Robert Kimberly encourages investigators from UAB and other CCTS partner institutions to “take advantage of the many programs, trainings, and collaboration opportunities CCTS provides in support of scientific excellence. That is our mission, and it is of critical importance to the future of our research enterprise and the health of our populations, both here in the Deep South and at the national level.”
To learn more about the rapidly changing clinical trial landscape, watch the video from our October 2016 CCTS Forum. Handouts and slide decks are also available on our Forum page (see slider for Oct. 5, 2016, “Federally Funded Clinical Trials: A Changing Policy Landscape”).
To help meet requirements for GCP training, Jester recommends starting with the basic course offered by Miami CITI. CCTS is developing training on third party oversight, data security, risk management, and correction and prevention steps for noncompliance. An enhanced training specifically for clinical investigators is also under development. Several other CCTS/UAB trainings offer GCP-related topics, including the monthly UAB Research Orientation program, suitable for all clinical trial team members; the biannual CCTS Research Coordinator Training program for staff; and the bimonthly CCTS Research Seminar. The next CCTS Research Seminar, scheduled for Jan. 5, 2017, will review in detail the coming requirements for registering and reporting in ClinicalTrials.gov.
To help meet requirements for registering and reporting clinical trials, CCTS offers help with research design, protocol development, and data analysis plans via the Biostatistics, Epidemiology, and Research Design (BERD) unit in Research Commons. Investigators can tap into one of the weekly BERD clinics or request a consultation via