Aisha Khan, PhD
University of Miami
United States
The Clinical Trials Transformation Initiative (CTTI), in collaboration with the U.S. Food and Drug Administration (FDA), presents this report. It focuses on the critical role of ClinicalTrials.gov as a primary information source for patients, healthcare professionals, researchers, and the public about clinical trials. The report highlights the legal requirements for responsible parties to submit clinical trial information, including registration and summary results, to ClinicalTrials.gov.
Theoretical Foundation and Imperative: The report emphasizes the significance of timely, accurate, and complete registration and reporting of clinical trial information, as mandated by regulatory requirements, medical journals, and the U.S. National Institutes of Health (NIH). It also underscores the ethical obligation to honor the participation of individuals by making findings publicly available. However, gaps in clinical trial registration and results submission to the data bank have been identified, indicating that the full value of the publicly available data bank has not been achieved.
Methodological Approach: To address these challenges, CTTI conducted a comprehensive investigation, including a literature review, qualitative in-depth interviews, and a survey. The interviews and survey aimed to identify organizational processes and policies; challenges affecting timely, accurate, and complete registration and reporting; and proposed solutions to enable improved registration and reporting of summary results information.
Empirical Findings: The study revealed a lack of understanding among Responsible Parties regarding the types of trials that must be registered and when results information must be submitted. Additionally, challenges related to the clarity of requirements, organizational policies, and lack of harmonization with other regulatory agencies and registries were reported. The report also provides insights into the advantages and disadvantages of a decentralized/distributed approach for clinical trial registration and reporting.
Identified Challenges and Concerns: Challenges identified in the report include Responsible Parties' understanding of regulatory timelines, organizational policies, and concerns about potential consequences of noncompliance. Additionally, there were concerns about waiting until all data are analyzed before reporting results information to prevent discrepancies between ClinicalTrials.gov records and published results, as well as concerns about disclosing competitive data.
Conclusive Insights and Recommendations: The CTTI report highlights the necessity for systematic, timely, accurate, and complete registration and reporting of clinical trial summary results information on ClinicalTrials.gov. It provides insights into stakeholder challenges and proposes solutions, emphasizing the importance of communication, education, and proactive centralized approaches. The report is a call to action for regulatory agencies and stakeholders to collaborate in enhancing the transparency, accuracy, and completeness of clinical trial information, ultimately benefiting public health and advancing medical research.
References
1. Clinical Trials Transformation Initiative. (2024). Improving Timely, Accurate, and Complete Registration and Reporting of Summary Results Information on ClinicalTrials.gov [PDF]. Retrieved from https://ctti-clinicaltrials.org/wp-content/uploads/2024/01/CTTI_SuggestedPractices_ClinicalTrials-gov_FINAL.pdf
2. Food and Drug Administration Amendments Act (FDAAA) of 2007. Public Law No. 110 – 85 § 801, 2007. Available at: https://www.govinfo.gov/content/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf#page=82.
3. The National Institutes of Health Did Not Ensure That All Clinical Trial Results Were Reported in Accordance with Federal Requirements. 2022. Accessed July 4, 2023. https://oig.hhs.gov/oas/reports/region6/62107000.asp
4. International Committee of Medical Journal Editors (ICMJE). Clinical Trials Registration. Accessed Sept 6, 2023 from https://www.icmje.org/about-icmje/faqs/clinical-trials-registration/.
5. National Institutes of Health (NIH). The NIH Policy on Dissemination of NIH-Funded Clinical Trial Information. Accessed Sept 26, 2023 from https://grants.nih.gov/policy/clinical-trials/reporting/understanding/nih-policy.htm
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