Changes Coming to Clinical Trial Regulations and Policies in 2017

The Food and Drug Administration (FDA) and National Institutes of Health (NIH) have recently finalized or signaled intent to finalize several proposals that aim to improve the quality and efficiency of clinical trial research. “These initiatives will reengineer the process by which clinical investigators develop ideas for new trials, how NIH reviews and selects clinical trials for support and oversees the progress of the research, and how results and aggregate data are shared broadly and rapidly,” writes Hudson et. al in JAMA.

The authors add that the changes “are aimed at enhancing the application and award processes, increasing NIH’s ability to assess the merits and feasibility of clinical trial applications; improving oversight and transparency; and increasing the sharing of clinical trial results.” This articles provides an overview of the initiatives.

Registration of Clinical Trials at ClinicalTrials.gov

Effective Date: January 18, 2017

Compliance Date: April 18, 2017

FDA and DHHS have expanded federal requirements to register clinical trials at ClinicalTrials.gov. These expanded requirements are the joint result of a new NIH policy and an expanded regulation from the U.S. Food and Drug Administration and the Department of Health & Human Services. NIH published a summary table describing the changes.

Some changes that might affect your ongoing and new trials are:

• NIH’s policy expands the registration requirement to all NIH-defined clinical trials funded by NIH (in whole, or in part) regardless of study phase or type of intervention.
  • You do not have to register ongoing trials funded by non-competing NIH extramural program awards.  You must register new clinical trials to be initiated on or after January 18, 2017 funded by a competing NIH extramural renewal application.
  • If your trial is funded through the NIH intramural program, you must register clinical trials initiated on or after January 18, 2017.
• FDA and NIH will provide a specific statement about ClinicalTrials.gov to include in the study consent form.
• You must register your trial within 21 days of the first participant signing the trial consent form.
• You must submit your trial results within 12 months of completing primary data collection.
• Possible non-compliance consequences include:
  • Identifying the clinical trial record as non-compliant in ClinicalTrials.gov
  • Suspension or termination of grant or contract funding, if required registration and reporting cannot be verified
  • Consideration of the non-compliance in future funding decisions
  • Civil monetary penalties to the “responsible party” (PI) of up to $10,000/day
• If it is not verified that the required registration and results for each applicable clinical trial for which a grantee is the responsible party has been submitted, any remaining funding for a grant or funding for a future grant to such grantee will not be released.

More information on the final rule can be found at the NIH website. Information on how to do the initial registration of a clinical trial is available on the UW Human Subjects Division website.

GCP Training Required for NIH-Funded Clinical Trials

Effective Date: January 1, 2017

NIH will require that PIs and clinical trial staff complete Good Clinical Practice (GCP) training for all new and ongoing NIH-defined clinical trials funded by NIH by January 1, 2017. GCP principles help assure the safety, integrity, and quality of clinical trials by addressing elements related to the design, conduct, and reporting.  Some specifics are:

• This training requirement is in addition to the NIH requirement for training on protections for human subjects.
• You must retain your own documentation of GCP training.
• You must refresh your training every 3 years.
• Current options to meet this requirement:
  • CITI learning program (select GCP)
  • NIH’s NIAID GCP Learning Center
  • National Drug Abuse Treatment Clinical Trials Network
  • NIH CTSA GCP for Social and Behavioral Research eLearning Course
• For new NIH-funded clinical trials, you must provide documentation of training completion as part of the Just-in-Time process. It is not clear yet how NIH will implement this requirement for current awards.

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-147.html

New Funding Opportunity Announcement (FOA) Policy for NIH-Funded Clinical Trials

Effective Date: September 27, 2017

In an effort to improve their ability manage submissions, reviews, and oversight of proposed NIH-defined clinical trials, NIH will no longer accept clinical trial applications through “parent” Funding Opportunity Announcements (FOAs) or through other FOAs that are not specifically designed to accept clinical trials.  All applications involving clinical trials received on or after September 27, 2017 must be submitted in response to a clinical trial-specific FOA.  Individual NIH Institutes and Centers will retain the flexibility to determine how best to design funding opportunities for clinical trials for their communities.

Understanding FDA’s Electronic Data Submission Standards

Effective Date:  December 17, 2016

In an effort to streamline the process of electronic data submissions, the FDA published guidance specifying electronic data formats for four types of submissions to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).  New clinical research data created as of December 17, 2016 must be captured in FDA’s submission-ready data formats for a successful filling of new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs).  Resources to assist with conformance to FDA requirements are available at the FDA website.