Overcoming non-compliance with clinical trial registration and results reporting: One Institution's approach

Sarah H Snider; Patrick A Flume; Stephanie L Gentilin; Whitney A Lesch; Royce R Sampson; Susan C Sonne

doi:10.1016/j.conctc.2020.100557

Overcoming non-compliance with clinical trial registration and results reporting: One Institution's approach

Contemp Clin Trials Commun. 2020 Mar 17:18:100557. doi: 10.1016/j.conctc.2020.100557. eCollection 2020 Jun.

Authors

Sarah H Snider¹, Patrick A Flume¹, Stephanie L Gentilin¹, Whitney A Lesch¹, Royce R Sampson¹, Susan C Sonne¹

Affiliation

¹ Medical University of South Carolina, Charleston, SC, 29485, USA.

Abstract

ClinicalTrials.gov is a web-based resource which provides the general public, healthcare professionals, patients, and caregivers access to privately and publicly supported clinical trials and trial results. The web site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH) (ClinicalTrials.gov Background, 2018). The penalties for non-compliance with the legal obligations under FDAAA 801 (Food and Drug Administration Amendments Act of 2007) and the NIH requirements for registering and reporting results on studies within certain timeframes can result in large monetary fines and the withholding of federal funds (ClinicalTrials.gov FDAAA 801 and the Final Rule, 2019). Years following, in 2016, the Final Rule expanded upon the requirement with additional data elements for both registration and result submission records in accordance of FDAAA 801 (ClinicalTrials.gov FDAAA 801 and the Final Rule, 2019). The Medical University of South Carolina (MUSC), along with the institution's Office of Clinical Research and Regulatory Knowledge & Support group, identified issues affecting their own compliance rate with FDAAA 801 and the NIH and implemented several processes to overcome these challenges. In short, these processes included hiring a designated full-time ClinicalTrials.gov coordinator, implementing a workflow that identifies trials early in the IRB approval process requiring registration (without effecting study start up timelines), assisting researchers when navigating the registration and results reporting process through one-on-one consultations, Lunch and Learns, and disseminating new training tools as they become available. Over the next 12 months the results of this approach demonstrated a marked increase to 98% overall compliance with these federal regulations which may provide valuable guidance for other institutions working toward improved compliance rates.

Abstract

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