Reimagining the clinical trial registry

Registry of the future

But even if patients are generally aware of clinical trials, where do they learn more details about them? The commonly accepted place where the information is kept is in government registries such as clinicaltrials.gov. Surveys have shown patients trust them the most. “They start digging there, but often they do not find information that is pertinent or understandable,” Moreira says, “and they start losing interest and all the work around awareness goes down the drain.”

In 2016, TransCelerate began working with patients and caregivers to develop a proof of concept for a Clinical Trial Registry of the Future. It employs the scenario of a user searching for information and opportunities for colorectal cancer trials to suggest several new features, capabilities and data types. It is intended to illustrate priority enhancements proposed for public registries based on patients’ stated priorities during the design process.

According to a TransCelerate white paper, patient feedback highlighted the need to simplify the process of searching for specific clinical trials seeking participants near a desired location.

In the proof of concept, a basic search function is available directly from the home page. After selecting one of three common search scenarios, the user may enter the desired medical condition, location of any type and a desired search radius from the location. In addition to a grid view, search results may also be plotted on a map view leveraging a Google Maps API, allowing for zoom-in and zoom-out capability and at-a-glance understanding of the geographical spread of available trials and trial sites.

Patient experience

A Participation tab was designed to address feedback from patients that they desire details about what it might be like to participate in a trial, but details are often missing from publicly available clinical trial information resources. To further enable simpler and faster refinement of search results from the search grid, users may also create their own trial comparison page. By checking boxes to the left of desired trial listings and clicking a “Compare Selected” button beneath the grid, the user is presented with a trial comparison page to quickly identify differences between options.

Dalvir Gill, TransCelerate’s CEO, says that improving patient experience in clinical trials is one of the organization’s strategic priorities, and it is working to do its part to provide data to clinicaltrials.gov in a more consistent format.

Gill explains, “As we started these discussions with clinicaltrials.gov, one of the things they rightly pointed out was for them to get better traction, we need to give them information in a more consistent manner, so we have just come up with a new project, the common data registry packet project.” Trans-Celerate member companies are going to try to standardize what they submit, how they submit it and the formatting. “The hope is that the data will become more consumable because it is going into the registry in a more uniform manner,” Gill adds.

When asked if the National Library of Medicine, which hosts the clinicaltrials.gov site, recognizes there is a usability issue, Gill replies, “What patients and clinicians want to do is consume that data. The folks who have responsibility aren’t naïve to the fact that its consumability and utility are not what we would want, but their remit is to get that information in. With any kind of governmental agency, it takes a little time to get to the right people, to sell the right idea and to get the traction. But I think the traction is there.”