Millions of people visit ClinicalTrials.gov each year to find a trial that they or a loved one might be eligible to join. It’s the largest public database of clinical studies in the world, listing more than 300,000 trials in the U.S. and around the world.
But as patients, families, and advocacy groups all say, ClinicalTrials.gov is not an easy website to use. Trial designs are confusing to users who aren’t familiar with clinical research. And inclusion and exclusion criteria, as well as outcome measures, often read as impenetrable medical jargon that only researchers can understand.
ClinicalTrials.gov was born when the Food and Drug Administration Modernization Act, which was enacted in 1997, mandated that a public registry of clinical trial information be established. Since its creation, it has become an important tool for patients looking for trials, a fact recognized and endorsed by the FDA and the National Institutes of Health. The FDA uses it as its chief patient search tool under “Clinical Trials: What Patients Need to Know,” and the NIH puts it at the top of its list of ways patients can find clinical trials.
If ClinicalTrials.gov is going to truly fulfill this role, however, it needs extensive improvement. The National Library of Medicine recognizes this, and is tackling it with a coordinated effort to modernize the site. It issued a request for information from the public, is assembling the comments it received, and plans to hold a virtual public meeting at the end of April.
The deficiencies of ClinicalTrials.gov are highlighted by other databases and search tools for patients seeking clinical trials that have emerged from patient advocacy groups, academic medical centers, and other organizations. To the extent that these can be tailored for specific geographic locations, or disease types, such curation can be helpful. Yet having information spread across multiple websites risks lack of harmonization among such websites, in terms of which trials are included or what search terms are effective for a particular search.
The best option would be for all trial seekers to use a retooled ClinicalTrials.gov that could quickly and easily allow them to restrict their searches to a particular geographic area, a single institution, or a disease type, rather than relying upon a patchwork of trial finders.
These other trial finders show only trials that are recruiting or that haven’t yet begun recruiting, instead of including past, present, and future trials in their results. After all, if you’re a patient looking for a trial to participate in, you aren’t interested in ones that have already closed.
As a repository for trials, ClinicalTrials.gov must be inclusive. But it should redesign its approach to searching to make it easier for patients to find the trials they seek. ClinicalTrials.gov does allow users to filter for “recruiting or not yet recruiting studies” on its homepage. The problem is that when given a choice between that option and “All studies,” patients tend to choose the latter option to ensure that they don’t miss anything. But in doing so, they can be presented with dozens, even hundreds, of irrelevant trials.
Imagine feeling hopeful when seeing a page seemingly full of opportunities, only to then discover that trial after trial has ended, been abandoned, or is no longer recruiting. It’s far better to have the query “Are you a patient looking for a trial?” front and center on the homepage. While the entire catalog of trials would still be in the database and be searchable, this reframing will give patients looking for participation opportunities only those trials relevant to them.
The homepage of ClinicalTrials.gov offers two main search bars: “condition or disease” and the nebulous “other terms,” examples of which include investigators’ names or the drug or device in question. In contrast, Trials Today takes users through a series of questions that filter search results relevant to the searcher’s situation. For example, patients recently diagnosed with a condition who are looking for trials can select the statements “I am looking for treatment options even those that are not yet approved” or “There are no available treatments at all.” Here, the search starts from the searcher’s situation rather than his or her having to guess which terms would be most helpful.
ClinicalTrials.gov could borrow other more straightforward design features from its peers to make it more user-friendly. Trials Today displays inclusion/exclusion criteria as soon as the searcher clicks on a trial, whereas on ClinicalTrials.gov, the user must scroll past information on treatment arms, interventions, and endpoints to find the criteria for participation, even though inclusion and exclusion parameters are arguably the most important information for a patient or family member to see upfront.
CenterWatch provides searchers with the ability to be notified of new relevant clinical trials, and flags exactly how close the user is to an enrollment site. Smart Patients provides forms that searchers can complete to be put in contact with trial teams. In its “Ask about the trial” section, a form allows patients to contact their own doctors with questions about a study listing. In some cases, Smart Patients also provides a form for contacting a relevant patient group (for example, “Ask the Colon Cancer Alliance”).
Such features open up opportunities for individuals to be more active and informed participants in finding clinical trials for themselves or someone else. These sites have user interfaces that are effective at directing searchers to the information that matters. All these changes could be adopted by ClinicalTrials.gov in its quest to “deliver an improved user experience on an updated platform that will accommodate growth and enhance efficiency.”
None of the trial finders do much to address the problem of clinical research terminology and jargon that the average person finds incomprehensible. For that, entities conducting trials should provide layperson-friendly translations of trial information, or at least of essential elements like inclusion and exclusion criteria and outcomes. This would mean more work for trial sponsors but, given that enrollment is essential to trials, it would be work that pays off in the end.
The move to modernize ClinicalTrials.gov is a unique opportunity to create one premier trial-finding site. Let’s make sure it gets done right.
Jamie Webb is a research associate in the Division of Medical Ethics at NYU Grossman School of Medicine and the project manager of its Working Group on Pediatric Gene Therapy and Medical Ethics. Alison Bateman-House, Ph.D., is an assistant professor in the Division of Medical Ethics at NYU Grossman School of Medicine and co-chair of its working groups on Compassionate Use and Preapproval Access, and on Pediatric Gene Therapy and Medical Ethics.