FDA and Clinical Trials Transformation Initiative (CTTI) Collaborate to Improve ClinicalTrials.gov

Jan 19, 2024 | News |

FDA and Clinical Trials Transformation Initiative (CTTI) Collaborate to Improve ClinicalTrials.govThe prompt and precise registration, as well as the timely dissemination of comprehensive summary results information for relevant clinical trials on ClinicalTrials.gov, play a pivotal role in providing current research insights to various stakeholders within the clinical trials domain.  

These stakeholders encompass patients, healthcare providers, study sponsors, investigators, regulatory bodies, payers, and leaders in the health system. Despite the regulatory mandates for the registration and reporting of applicable clinical trials, and the inherent importance of ensuring transparency while enhancing awareness of potential new treatments in progress, numerous publications have highlighted deficiencies in the submission of clinical trial registration and results information to the database. 

The Clinical Trials Transformation Initiative (CTTI) is a public-private partnership created in 2007 between the United States Food and Drug Administration (FDA) and Duke University for the purpose of identifying practices that will increase the quality and efficiency of clinical trials. To tackle this challenge, CTTI embarked on a comprehensive project aimed to comprehend the obstacles impeding the timely, accurate, and complete registration and reporting of summary results information for relevant clinical trials on ClinicalTrials.gov. The project utilized in-depth interviews and surveys to identify barriers, their significance based on stakeholder types, root causes influencing these barriers, and potential solutions and best practices for implementation. Following the analysis of relevant themes, CTTI surveyed 92 individuals representing 84 unique organizations, synthesizing the findings into a report containing strategies and recommendations for enhancing registration and reporting. 

Some key strategies proposed in the report include but are not limited to:  

  • Adopting a centralized/dedicated approach to meeting ClinicalTrials.gov requirements 
  • Taking a proactive stance toward compliance 
  • Escalating non-responsive instances to upper leadership levels 
  • Educating Principal Investigators (PIs) and study teams about the consequences of non-compliance. The report emphasizes the separation between submitting results information on ClinicalTrials.gov and publishing results in journals.  

Challenges identified by respondents revolved around a lack of understanding among PIs and study teams regarding the types of trials that must be registered, which results require submission, and timeframes on when registration and results reporting need to occur. Respondents also reported difficulties with non-responsive PIs and study teams, impacting the timely registration and reporting of results. Concerns were expressed about waiting for complete data analysis before reporting results on ClinicalTrials.gov to prevent discrepancies with published results.  

For further details, the full report can be accessed at the link below.

CTTI_SuggestedPractices_ClinicalTrials-gov_FINAL.pdf (ctti-clinicaltrials.org) 

Do you need assistance with understanding requirements, registering, and/or reporting your trial results? MEDIcept has an experienced clinical team who would be glad to assist you every step of the way. Reach out to us today at sales@medicept.com to get started!  

Ava Carr – Content Creator