Dissemination Approaches For Different Stakeholders
Reporting to the Scientific Community: ClinicalTrials.gov
Karen Staman, MS
Gina Uhlenbrauck, ELS
Liz Wing, MA
In 2016, the U.S. Department of Health and Human Services clarified and codified Section 801 in a final rule governing the registration and data reporting for clinical trials with ClinicalTrials.gov. The rule requires sponsors or principal investigators to register clinical trials and report key data about the trial design, study population, and outcomes.
ClinicalTrials.gov is a publicly available registry and database for clinical trials. Publicly and privately supported studies that involve human subjects research are required to register on the site (and provide the design of the study) before patient enrollment begins and provide summary results no less than 12 months after the study ends. The registry was developed to help ensure information about human subjects research is expediently added to the public knowledge base and to enable a full understanding of the effectiveness of interventions and therapies. The registry also provides a platform to document the frequency and severity of side effects, prevent duplicating studies, and help prospective researchers plan future studies. Because journals often reject papers with negative results, small studies, and trials stopped early, ClinicalTrials.gov is a critical dissemination strategy that fills in these gaps (Piller 2015a). However, this registry was created with a traditional explanatory trial in mind, and is not ideally suited to the reporting of pragmatic trials or implementation research. An improved structure for reporting ePCTs would be beneficial for this type of research.
Although reporting all results—including negative results—is critical to the scientific process, overall compliance with FDA requirements is poor (Anderson et al. 2015; Miller et al. 2015; Piller 2015b); about half of clinical trial results go unreported (Anderson et al. 2015), and most research institutions fail to report some of their trials (Piller 2015a). (For more, see this interactive map.) Although the government can levy a fine of up to $10,000 a day or suspend research funding for failure to report results, it has not penalized any institution (Piller 2015a). Reasons for low reporting include: lack of money set aside in budgets for reporting, time burden, lack of incentive, delay for the creation of a journal article, or pressure from sponsors.
Before an FDA law requiring investigators to publish summaries of trial results on ClinicalTrials.gov went into effect in December 2007, some participants in clinical research were unable to find the results of the research in which they participated, as this article in the Atlantic describes (Yasinski 2016). Although the majority of patients want to know the results of the clinical trial in which they participated (Shalowitz and Miller 2008), fewer than 10% of them actually receive this information (Getz et al. 2012). Patients may not know of the existence of ClinicalTrials.gov, and even if they do, the language is often written for audiences other than for patients, and consequently, the information provided may not be written in a clear, plain language that is understandable to average readers.
The Clinical Trials Transformation Initiative (CTTI) created the Aggregate Analysis of ClinicalTrial.gov (AACT) database, which is a publicly-accessible ClinicalTrials.gov dataset that can be used to analyze studies and characterize the current state of clinical trials, including at the individual specialty level.
The product list contains publications, information regarding the methodology leading to the creation of AACT, tips, and example analyses.
Anderson ML, Chiswell K, Peterson ED, Tasneem A, Topping J, Califf RM. 2015. Compliance with Results Reporting at ClinicalTrials.gov. N Engl J Med. 372:1031–1039. doi:10.1056/NEJMsa1409364. PMID:25760355.
Getz K, Hallinan Z, Simmons D, et al. 2012. Meeting the obligation to communicate clinical trial results to study volunteers. Expert Rev Clin Pharmacol. 5:149–156. doi:10.1586/ecp.12.7. PMID:22390557.
Miller JE, Korn D, Ross JS. 2015. Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012. BMJ Open. 5:e009758. doi:10.1136/bmjopen-2015-009758. PMID:26563214.
Piller C. 2015a. Law ignored, patients at risk. STAT: Reporting from the frontiers of health and medicine. https://bioethics.georgetown.edu/2017/02/law-ignored-patients-at-risk/ Accessed Aug 1, 2017.
Piller C. 2015b. Failure to report: About the investigation. STAT: Reporting from the frontiers of health and medicine.
Shalowitz DI, Miller FG. 2008. Communicating the Results of Clinical Research to Participants: Attitudes, Practices, and Future Directions. PLoS Medicine. 5:e91. doi:10.1371/journal.pmed.0050091. PMID:18479180
Yasinski E. 2016 Jan 11. The Outcome of My Clinical Trial Is a Mystery. The Atlantic. https://www.theatlantic.com/health/archive/2016/01/clinical-trial-unpublished-results/423540/ Accessed Aug 1, 2017.