From certification in Good Clinical Practice (GCP) to reporting research results, the federal bar is being raised across the clinical trial lifespan. With its October Forum, the CCTS sought to prepare clinical trial teams across the partner network to “get out in front” of the wave of policy changes. 

New GCP Requirement
Penny Jester, director of the CCTS Clinical Research Support Program (CRSP), discussed the new GCP training policy. By Jan. 1, 2017, all NIH-funded investigators and staff involved in conduct, oversight, or management of clinical trials must have documented proof of GCP training from a recognized clinical research professional organization. The goal, Jester explained, is to ensure the “safety, integrity, and quality” of clinical trials, consistent with the principles of the International Conference on Harmonization (ICH) E6. The training must be refreshed every three years. 

Jester encouraged the audience to start with the basic course offered by Miami CITI, but noted “this is just the beginning. Pending changes implemented by the ICH will require enhanced training in the near future.” Additional training on 3rd party oversight, data security, risk management, and correction and prevention steps for non-compliance “are also on the horizon.” She announced that CCTS is already developing an enhanced training for clinical investigators and noted several other CCTS/UAB trainings that offer enhanced GCP material (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). 

Addressing the impact on non-NIH trials, Jester emphasized that all human research, whether locally funded or industry sponsored, “ethically requires the same standards as that of NIH funded clinical trials.” Showing a slide of the Top Ten GCP issues cited by the FDA 483s (the FDA warning letter sent to research with compliance issues), she added, “this list demonstrates the need for GCP guidelines that protect the rights of study subjects and assure accurate and reliable collection of data in research.” 

Reporting Results Requirements
Jester turned next to the new requirements for reporting results on ClinicalTrials.gov (CT.gov). The Department of Health and Human Services (HHS) has released a Final Rule, which the NIH has broadened and attached penalties to for non-compliance (see “Federal Reforms Will Reshape Clinical Trials,” CCTS Digest 30 Sept. 2016). The goal, Jester said, “is to increase transparency and accountability—to share results more broadly and rapidly for the benefit of the public we serve.” The new reporting rules will take effect Jan. 18, 2017. 

One of the major changes, she explained, is that investigators will be required to upload their entire protocol and a statistical analysis plan. “What this means is NIH will be able to see if your primary and secondary endpoints agree up with what you set out to do in your protocol,” she said. Noncompliance with the new reporting requirements can result in loss of funding and fines, “as much as $10,00 a day.” Her slides listed the universe of different protocols that must be posted on CT.gov. She urged investigators to take advantage of CCTS research design and protocol development supports and to stay tuned as NIH continues to work on the CT.gov website.

Single IRB Requirement
The next speaker, UAB Interim IRB Director Leslie Cooper, discussed the rationale behind the move toward single IRBs of record for multisite trials. The goal, she said, is to “streamline review, improve efficiency, and reduce administrative burdens.” The final NIH policy on use of a Single IRB was released in June 2016 and applies to all competing grant applications (new, renewal, revision, or resubmission) with receipt dates on or after May 25, 2017. 

Cooper reviewed the applicant responsibilities, including what grantees should do when a single IRB is not yet identified. One positive change she noted is that applicants, with appropriate justification, may request direct cost funding for the review of a multi-site study by a single IRB. In preparation of the new requirement, the UAB Office of the IRB is working to update and refine the IRB handbook and template for reliance agreements, educate the research community and IRB members, and create a single IRB section on the website. 

Clinical Trial Grant Submission Requirement
Dr. David Redden, codirector of CCTS Biostatistics, Epidemiology, and Research Design (BERD), addressed the rule requiring NIH grant applicants requesting support for one or more clinical trials to respond to clinical trial-specific funding opportunity announcements (FOAs). As of Sept. 27, 2017, NIH will no longer accept clinical trial applications submitted via a “parent” FOA. The new FOA mechanism for clinical trial grants will require specific information regarding study rationale, design, operational plans, and analysis plans. A new protocol template for phase 2 and 3 IND/IDE trials will also be rolled out. “It’s effort to write a solid protocol in a timely manner—but don’t forget, CCTS BERD is here to help.”

In case you were unable to attend, the Oct. Forum slides, handouts, and video are now available on our Monthly Forum page.
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