Timely, accurate, and complete registration and reporting of summary results for applicable clinical trials on ClinicalTrials.gov are essential for providing patients, providers, researchers, and the public with access to information about clinical trials and their outcomes. Failure to do so diminishes the value of this publicly available data bank.

Challenges Meeting U.S. ClinicalTrials.gov Reporting Requirements

As part of this work, CTTI conducted in-depth interviews and surveys to collect data.

In-depth interview objectives:

• Describe organizational processes and policies on ClinicalTrials.gov registration and reporting of results information
• Identify challenges that affect registration of applicable clinical trials and reporting of results information on ClinicalTrials.gov and proposed solutions

Survey objective:

• Describe the prevalence of ClinicalTrials.gov processes, challenges, and solutions

Strategy and Best Practices Report:

• Describe best practices that support the timely, accurate, and complete registration of applicable clinical trials and submission of clinical trial results information on ClinicalTrials.gov – ACTs
• Ensure ClinicalTrials.gov includes timely and complete information about applicable clinical trials for those seeking information about clinical trials.

CTTI interviewed 25 individuals representing 26 unique organizations to identify the range of barriers experienced by a variety of stakeholders, the root causes of these barriers, and potential solutions. CTTI used these initial findings to develop a survey to identify and quantify the most salient barriers to timely, accurate, and complete registration and reporting on ClinicalTrials.gov of applicable clinical trials. After surveying 92 individuals who represented 84 unique organizations, CTTI condensed the findings into a report containing strategies for improving registration and reporting of applicable clinical trials.

When describing challenges with registering and reporting applicable clinical trials, respondents cited several major challenges:

• A lack of understanding on the part of the Principal Investigator (PI) and their study team regarding
  • the type of trials that must be registered,
  • when they should be registered, and
  • which trial results information must be submitted and when.

• Administrative groups also reported challenges relating to non-responsive PIs and study teams, which hinder both timely registration and reporting of results of applicable clinical trials.

• For reporting, PIs and study teams responding to the survey also expressed concerns about waiting until all data are analyzed before reporting results information on ClinicalTrials.gov to prevent discrepancies between ClinicalTrials.gov data and published results.

Some of the strategies include:

• Use a centralized/dedicated approach to meeting ClinicalTrials.gov requirements
• Take a proactive, rather than reactive, approach to complying with ClinicalTrials.gov regulatory requirements
• Escalate to upper levels of leadership for PIs/study teams that are non-responsive to the administrative unit’s communication about compliance
• Inform PIs/study teams
  • about the possibility of civil money penalties for non-compliance with ClinicalTrials.gov regulatory requirements
  • that submitting results information on ClinicalTrials.gov is separate from publishing results in journals
  • that per ICMJE, reporting results information on ClinicalTrials.gov does not preclude publishing results in journals
• Provide education, resources, guidance, and support about meeting ClinicalTrials.gov requirements to PIs/study teams and other research personnel

See the full report for a complete list of strategies.

CTTI used the data described in this report to describe best practices that support the timely, accurate, and complete registration of applicable clinical trials and submission of applicable clinical trial results information on ClinicalTrials.gov.  

Organization affiliations are listed as active affiliations during the project.

*Indicates former project manager, team leader, or team member.