Project:

Challenges Meeting U.S. ClinicalTrials.gov Reporting Requirements

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Timely and complete registration and reporting of summary results information for applicable clinical trials to ClinicalTrials.gov is an important part of providing patients, providers, researchers, and the public with access to information about clinical trials and their results. Despite the legal requirements and importance of this critical access and transparency, as it limits duplication and encourages others to build on results, public reporting suggests that not all clinical trials are registered in a timely manner or they have incomplete results.

To address this problem, CTTI is conducting in-depth stakeholder interviews and surveys to identify and explore the key challenges to clinical trial registration and results reporting and to identify potential solutions.

CTTI will use the resulting data to develop best practices for responsible parties and other stakeholders. CTTI will also issue recommendations to support the registration and results reporting process. The goal is to ensure ClinicalTrials.gov includes timely and complete information for those seeking information about clinical trials.

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Project Team Members

Role Namesort descending Affiliation
Lead Social Scientist Amy Corneli Clinical Trials Transformation Initiative
Team Member Bridget Foltz Food and Drug Administration
Team Member Constance Cullity Advarra
Team Member David Markert Food and Drug Administration
Team Member Derek Griffing National Institutes of Health
Team Member Donell Carey
Team Member Donna Cryer Global Liver Institute
Team Member Jan Hewett Food and Drug Administration
Team Member Jocelyn Riley Cleveland Clinic
Team Member Jodi Black Food and Drug Administration
Team Member Julia Eckstein Food and Drug Administration
Team Member Kimberly Taylor Food and Drug Administration
Team Member Kristen Miller Food and Drug Administration
Team Member Laura Levit ASCO
Communications Manager Laura Shannon Clinical Trials Transformation Initiative
Team Member M. Khair ElZarrad Food and Drug Administration
Team Member Margaret Rankovic CITI Program
Team Member Miah Jung Food and Drug Administration
Team Member Patrick Zhou Food and Drug Administration
Project Manager Sara Calvert Clinical Trials Transformation Initiative
Team Member Sherry Bous Food and Drug Administration
Team Member Susan Stein Cleveland Clinic
Assistant Social Scientist Teresa Swezey Clinical Trials Transformation Initiative