The Patients 2 Consortium: Accelerating Patient Enrollment in Clinical Trials

May 28, 2015
Michael Christel

Michael Christel is Pharmaceutical Executive and Applied Clinical Trials' Managing Editor. He can be reached at mchristel@mmhgroup.com.

Emerging technology partnerships in the biopharma space may be provide hope in accelerating patient enrollment, writes Michael Christel.

Engaging and recruiting participants for clinical trials continues to be a struggle for the life sciences industry. However, emerging technology partnerships in the biopharma space may be providing hope in accelerating patient enrollment and reducing bottlenecks through a concentrated focus on target profiles.

One example is the Patients 2 Trials Consortium, formed in recent years by Novartis, Eli Lilly & Co., and Pfizer around the mission of developing a standard language for patients interested in clinical trial opportunities. To that end, the companies have since agreed on target profiles that best define and normalize groups of patients who may match up well to a particularly study, and have built interfaces that leverage reader-friendly protocols. Representatives of the three sponsors spoke during a Partnerships in Clinical Trials session on the progress of the consortium to date, and were joined by Pablo Graiver, co-founder and CEO of TrialReach, a startup online platform company that is partnering with the group on creating the infrastructure to connect the standard datasets to prospective patients.

David Leventhal, Director, Clinical Innovation, Worldwide Research and Development at Pfizer, said the collaboration spawned from the need for sponsors to be self-determined about their capabilities in funneling patients to the appropriate clinical trials. He noted that the struggles in this area are shared by all drug developers, in all therapeutic areas-a realization, Leventhal says, that has resulted in increased partnering around optimizing target profiles. For example, agreeing on what specific profiles constitute the kind of patient looking for a study in type 2 diabetes or Alzheimer’s disease or non-small cell lung cancer.

Lani Hashimoto, online patient recruitment specialist at Novartis, explained that in order for patients to have more choices of clinical trials, it requires scale, an effort that can more reasonably be accomplished through the collective efforts of consortiums such as Patients 2 Trials. Katherine Vandebelt, Senior Director, Clinical Development Innovation at Lilly, noted that part of achieving such scale is having teams spend time interacting with patients to learn about their frustrations and difficulties in finding clinical trials. This information, Vandebelt noted, specifically helped Novartis create an application programming interface (API) to match patients against all available trials to find the appropriate ones for each individual. Demonstrating the targeted approach in action, Vandebelt said, can help foster increased patient trust and confidence that a trial they are interested is ultimately right for them. And by partnering with other sponsors to share an open space for interaction, patients can benefit from greater access to studies.

During the session, Graiver gave a live demonstration of TrialReach’s platform, which amasses thousands of clinical trials from various sources, and, using the consortium’s target profiles, standardizes language in a study protocol. Graiver showed how users can provide answers to simple questions such as condition, location, age, etc., and as each field is inputted, the search results of available trials is narrowed down accordingly. The tool also allows the ability to check off boxes listing the procedures involved in a study. Through reading the eligibility criteria, the algorithm continuously ranks and refines studies to present results in plain language. These searches are saved as a patient’s profile, with each one generating a targeted body of information.

The consortium is planning to make this search capability accessible by embedding it on disease-specific websites, where prospective patients are already active. In turn, sponsors can use any resulting queries to display maps of matches and information on specific patient populations to help improve the design of trials.    

While the benefits of this technology are promising, Leventhal stresses that maintaining its driving component-the consortium members agreeing on target profiles (i.e., what constitutes the disease state, the inclusion/exclusion criteria)-is the key to any future success in accelerating patient enrollment.