Challenges Meeting U.S. ClinicalTrials.gov Reporting Requirements

Topics Included: Data Collecting and Reporting, Regulatory Submissions + Approvals

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Timely, accurate, and complete registration and reporting of summary results for applicable clinical trials on ClinicalTrials.gov are crucial for providing patients, providers, researchers, and the public with access to information about clinical trials and their outcomes. Despite regulatory requirements and the importance of transparency in increasing knowledge of potential new treatments, multiple publications have reported gaps in clinical trial registration and results submission to the data bank.

To address this issue, CTTI collaborated with the U.S. Food and Drug Administration (FDA) on a project to understand barriers to timely, accurate, and complete registration and reporting of summary results for applicable clinical trials on ClinicalTrials.gov. The project involved in-depth stakeholder interviews and a survey to identify key challenges and explore potential solutions.

CTTI assessed the relevant themes and condensed the findings into a report containing strategies and recommendations for improving registration and reporting of summary results for applicable clinical trials. These strategies include proactive approaches to comply with regulatory requirements, keeping principal investigators and study teams informed, and providing education and guidance on meeting requirements. You can read the full report for a complete list of strategies.

Additionally, CTTI is developing a list of resources to assist with registering applicable clinical trials and reporting results on ClinicalTrials.gov.

What is the issue?

What CTTI project has been initiated to address this issue?

What are the objectives of this project?

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.

What research was done to collect data for the report?

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.

What were some of the challenges reported when registering and reporting results information for applicable clinical trials on ClinicalTrials.gov?

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.

What are the strategies created for improving registration and reporting?

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.

What is the anticipated impact of CTTI’s work on this topic?

Project Team Members

Role	Name	Affiliation
Assistant Social Scientist	Teresa Swezey	Clinical Trials Transformation Initiative
Communications Manager	Laura Shannon*	Clinical Trials Transformation Initiative
Lead Social Scientist	Amy Corneli	Clinical Trials Transformation Initiative
Project Manager	Sara Calvert	Clinical Trials Transformation Initiative
Project Manager	Kelly Franzetti	Clinical Trials Transformation Initiative
Team Member	Jodi Black*	Food and Drug Administration
Team Member	Milagros Blazquez	Bristol Myers Squibb
Team Member	Sherry Bous	Food and Drug Administration
Team Member	Donell Carey
Team Member	Donna Cryer	Global Liver Institute
Team Member	Constance Cullity	Advarra
Team Member	Julia Eckstein*	Food and Drug Administration
Team Member	M. Khair ElZarrad	Food and Drug Administration
Team Member	Bridget Foltz*	Food and Drug Administration
Team Member	Elisa Golfinopoulos	National Institutes of Health
Team Member	Derek Griffing*	National Institutes of Health
Team Member	Jan Hewett	Food and Drug Administration
Team Member	Sandra Hodnick	Cleveland Clinic Coordinating Center for Clinical Research (C5Research)
Team Member	Miah Jung	Food and Drug Administration
Team Member	Laura Levit	ASCO
Team Member	David Markert	Food and Drug Administration
Team Member	Kristen Miller	Food and Drug Administration
Team Member	Mike Patrizii	Bristol Myers Squibb
Team Member	Margaret Rankovic	CITI Program
Team Member	Jocelyn Riley	Cleveland Clinic
Team Member	Navaneetha Santhanam*	Bristol Myers Squibb
Team Member	Susan Stein	Cleveland Clinic
Team Member	Kimberly Taylor	Food and Drug Administration
Team Member	Patrick Zhou	Food and Drug Administration

Organization affiliations are listed as active affiliations during the project.

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

Resources

Regulatory Submissions + Approvals | Webinars

Improving Timely, Accurate, and Complete Registration and Reporting of Summary Results on ClinicalTrials.gov

Meeting page including webinar recording and materials

Regulatory Submissions + Approvals | Media Coverage

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CTTI

Clinical Trials Transformation Initiative

Challenges Meeting U.S. ClinicalTrials.gov Reporting Requirements

Challenges Meeting U.S. ClinicalTrials.gov Reporting Requirements

Resources

Improving Timely, Accurate, and Complete Registration and Reporting of Summary Results on ClinicalTrials.gov

Best Practices For Complete Registration And Reporting Of Summary Results On ClinicalTrials.gov

Improving Timely, Accurate, and Complete Registration and Reporting of Summary Results Information on ClinicalTrials.gov

CTTI and FDA Share Strategies for Improving Timely, Accurate, and Complete Registration and Reporting of Summary Results Information for Applicable Clinical Trials on ClinicalTrials.gov

CTTI Conducting Survey on Registering and Reporting Clinical Trial Information on ClinicalTrials.gov

New CTTI Project to Explore the Challenges Preventing Timely and Complete ClinicalTrials.gov Reporting

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