To Improve Patient Recruitment, Provide Investigative Site Contact Information
By Christa Polidori, clinical trial disclosure manager, Bristol-Myers Squibb
Patients are the most fundamental part of a clinical trial. However, many do not know how to find a clinical trial and are unaware of actively recruiting clinical trials for which they may be eligible. Furthermore, even for patients who successfully identify potentially suitable trial opportunities, it’s often difficult to find the information they need to take the next steps in participation. There are several ways clinical trial sponsors can improve patient recruitment and bridge the gap between individuals willing to participate in a clinical trial and those who enroll. One way clinical trial sponsors can meet the preferences of modern and digitally connected patients is through the disclosure of contact information for individual clinical trial sites on public registries.
According to survey results recently published in Therapeutic Innovation & Regulatory Science (TIRS), a high proportion of patients (94 percent) have a desire to be more informed of clinical trials conducted in their community, but a large majority (79 percent) claimed they were unaware of clinical trials recruiting for their condition of interest. In the search for a clinical trial, 76 percent of patients said site contact information was the most valuable information to have before participating. Additionally, most patients indicated they would be willing to contact a clinical trial location directly, if contact information was available. Furthermore, the Internet was reported as the key means for patients to learn of and search for clinical trials.
Clinical trial sponsors were surveyed to better understand disclosure practices on public registries. The majority (77 percent) of responding sponsor companies reported they do not post site-specific contact information such as site names, addresses, and phone numbers/email addresses on the government registry, ClinicalTrials.gov. The absence of specific clinical trial site location and contact information on such online registries may create a barrier between patients and specific trial opportunities.
Feedback indicated the investigative site community supports a greater linkage between patients and clinical trial sites. In a global survey, most site professionals (91 percent) were willing to publicly disclose contact information for their site to help patients find them. Sponsors should work with investigative sites to understand their preferences and infrastructure and determine possible options by which patients can be directly connected to sites. Additionally, 92 percent of patient respondents said they would be interested in registering their contact information on a secure website to be notified when relevant trial opportunities arise. This could present a long-term opportunity for sponsors and individual sites to create patient databases that can be utilized when recruiting for future clinical trials.
The need for increased accessibility of clinical trial information is one of the major industry issues that prompted the TransCelerate Clinical Research Access & Information Exchange (CRAIE) Initiative to focus on recommendations that could help facilitate the disclosure of simple, user-friendly information on clinical trial registries. The Initiative identified greater visibility of site contact information as a practical first advance toward a goal of more patient-centric clinical trial registries.
Our industry aims to provide insights and recommendations that can mend the broken links between clinical research stakeholders. Research shows providing clear and accessible contact information for individual clinical trial sites to patients through public registries is desired by both the patient and investigative site communities. If sponsor companies work with sites to improve visibility of site contact information, patients may be enabled to make more informed decisions regarding clinical trial participation; sites may potentially accelerate recruitment; and all stakeholders could benefit from accelerated development of novel therapeutics.
About the Author:
Christa Polidori currently serves as the clinical trial disclosure manager in global clinical operations at Bristol-Myers Squibb, a global biopharmaceutical company whose mission is to discover, develop, and deliver innovative medicines that help patients prevail over serious diseases.
Bristol-Myers Squibb is a member of TransCelerate BioPharma Inc., a nonprofit organization with a mission to collaborate across the biopharmaceutical research and development community to identify, prioritize, design, and facilitate the implementation of solutions that drive efficient, effective, and high-quality delivery of new medicines, improving the health of people around the world. Polidori is a leader on the TransCelerate Clinical Research Access & Information Exchange Initiative.