Guest post by Kevin M. Fain, JD, MPH, DrPH, Senior Advisor for Policy and Research, ClinicalTrials.gov.
ClinicalTrials.gov is the largest public clinical research registry and results database in the world—and the most heavily used. As of today, it contains registration information for more than 260,000 studies in 202 different countries and results information on more than 29,000 of those studies. Each week, the content grows by approximately 560 new registrations and 110 new results submissions. The system averages more than 162 million page views per month and 93,000 unique visitors daily.
ClinicalTrials.gov enables users to: (1) search for clinical trials of drugs, biologics, devices, and other interventions; (2) obtain summary information about these studies (e.g., purpose, design, and facility locations); (3) track the progress of a study from initiation to completion; and (4) obtain summary results, often before they are published elsewhere.
In addition, the unique ClinicalTrials.gov identifier assigned to each registered trial (commonly referred to as the “NCT Number”) has become the de facto standard for referencing trials and is widely and routinely used in medical journal articles, MEDLINE citations, and the mass media.
Federal law underlies the ClinicalTrials.gov database requirements and content. NIH launched the database in 2000 after the Food and Drug Administration Modernization Act of 1997. The FDA Amendments Act of 2007 then expanded the database’s scope and purpose by requiring registration and results reporting for certain clinical trials of FDA-regulated drugs, biological products, and medical devices. Importantly, the 2007 law included legal consequences for noncompliance, including civil monetary penalties.
More recently, in an effort to make information about clinical trials more widely available to the public, the US Department of Health and Human Services issued a final rule in September 2016 that specifies requirements for registering certain clinical trials and submitting summary results information to ClinicalTrials.gov. The rule’s final form was shaped by over 900 public comments.
The new rule, which became effective one year ago (January 18, 2017), clarifies and expands the reporting requirements for clinical trials, including trial results for drug, biologic, and device products not approved by FDA. At the same time, NIH issued a policy establishing the expectation that all investigators conducting clinical trials funded in whole or in part by NIH will ensure these trials are registered at ClinicalTrials.gov and that results information for these trials is submitted to ClinicalTrials.gov.
The expanded reporting requirements are expected to yield important scientific, medical, and public health benefits—from improving the clinical research enterprise itself to maintaining the public’s trust in clinical research. Having access to complete study results, including negative or inconclusive data, can help counteract publication bias, reduce duplication in research, improve the focus and design of future studies, and protect patients from undue risk or ineffective interventions. That additional information, in the context of other research, can also help inform health care providers and patients regarding medical decisions.
As a repository for study results, ClinicalTrials.gov helps deliver those benefits.
Recent research indicates that the results of many clinical trials—including those funded by NIH—are never published. And even when results are published, they can be limited, focusing on findings of most interest rather than all outcomes. In contrast, studies have found results reported in ClinicalTrials.gov are more complete than in the published literature. The new reporting requirements are expected to strengthen that characteristic and enhance the benefits ClinicalTrials.gov brings.
It is important to understand that listing a study on ClinicalTrials.gov does not mean it has been evaluated by the US Federal Government. The ClinicalTrials.gov website emphasizes this point for the public through prominent disclaimer statements, including one on the importance of discussing any clinical trial with a health care provider before participating.
ClinicalTrials.gov allows for the registration of any human biomedical study that conforms with prevailing laws and regulations, including an indication that recruiting studies were approved by an ethics review committee. As a result, the database is more comprehensive, which can better serve the public in critical ways. For example, potential participants can see the full range of studies being conducted, not just those funded or sponsored by NIH. Ethics committees, funders, and others can also view the wider scope of studies, which can help them more effectively oversee new research.
Aside from legislative and policy changes, ClinicalTrials.gov has also focused on enhancing the site’s usability, addressing design and layout issues and improving the ability to search, display, and review information about the studies registered on the site. The latest set of updates, released last month, included new search options (such as by recruitment status and distance from a geographic location), refinements to the display of search results, and additional information regarding study results and key record dates. These changes, plus those brought about by the final rule, will help maximize the value of clinical trials, and by extension, advance knowledge and improve health.
From finding trials actively recruiting participants to identifying new experimental drugs or device interventions to analyzing study design and results, ClinicalTrials.gov delivers key benefits to patients, clinicians, and researchers and puts into action NIH’s core mission: turning discovery into health. It also reflects one more way NLM makes medical and health information available for public use and patient health.
Kevin Fain, JD, MPH, DrPH, has served as senior advisor for policy and research at ClinicalTrials.gov since 2015. He was an attorney with the FDA from 1995-2010, specializing in clinical trial and drug regulatory matters. He earned his doctorate in epidemiology from Johns Hopkins University in 2015.