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Compliance In Focus
Posted by Emily Haglund on Tue, Oct 25, 2016

Increased Transparency Requirements with clinicaltrials.gov

The US Department of Health and Human Services (DHHS) recently released a final ruleclinicaltrails.jpg regarding the specific requirements for the registering and results submission of clinical trials within the clinicaltrials.gov database. As previously, the final rule applies to “responsible parties” for “applicable clinical trials.” Responsible parties are frequently the sponsor of a clinical trial or principal investigator. Applicable clinical trials must meet certain criteria.

These new requirements for clinicaltrials.gov include the following provisions

  • Providing a checklist for evaluating which clinical trials are subject to the regulations and who is responsible for submitting required information; 
  • Expanding the scope of trials for which summary results information must be submitted to include trials involving FDA-regulated products that have not yet been approved, licensed, or cleared by the FDA; 
  • Requiring additional registration and summary results information data elements to be submitted to ClinicalTrials.gov, including the race and ethnicity of trial participants, if collected, and the full protocol; 
  • Requiring additional types of adverse event information; and 
  • Providing a list of potential legal consequences for non-compliance.

Simultaneously, the National Institutes of Health (NIH) issued a policy regarding requirements for all NIH-funded trials. Specifically, this applies to:

‘… all clinical trials funded in whole or in part by NIH, regardless of study phase, type of intervention, or whether they are subject to the Final Rule…. clinical trials which are defined as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”’

The increased transparency within the clinical research field has the potential for significant advantages in development of the clinical research process. The registration of clinical studies and subsequent availability for public access may improve the ability of potential subjects to find and participate in clinical studies, particularly for investigational therapies. Also, FDA Commissioner, Robert M. Califf, MD, described the increased transparency would improve clinical trial “focus and design.” JAMA released commentary in support of the activities NIH has initiated to facilitate a more robust clinical research process; NEJM also provided a special report that described how the final rule will create accountability for the clinical research process in the scientific community.

A compliance date associated with the final rule is January 18, 2017; the FDA can issue a “Notice of Noncompliance” to a responsible party that has failed to comply with the requirement. A lack of compliance with the NIH policy could influence the conditions of the monetary award.

How will these changes truly impact subjects, sponsors, and investigators? What will be the short and long term impacts?

Data Safety Monitoring Boards and Clinical Events Committees

photo credit: Jim Makos Typing via photopin (license)

Topics: National Institutes of Health, FDA ClinicalTrials.gov, The Department of Health and Human Services


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