Achieving a “Win-Win” by Using Technology for Recruitment

If you are reading this article, you are interested in advancing medicine through research. You may know, all too well, the challenges involved when conducting a clinical trial, and that recruitment of research study participants is one of the most challenging aspects of trial completion. In fact, a 2015 analysis of registered trials on ClinicalTrials.gov revealed that 19% were closed or terminated early because they could not accrue enough participants. As many as 86% of clinical trials do not reach recruitment goals within their specified enrollment periods. {1} Add to this, the challenge of limited budgets for recruitment and the reliance on traditional methods such as word of mouth, physician referral, e-mail and fliers, and institutional or disease-specific registries. {2}

To create new “win-win” opportunities both for investigators and for U.S. volunteers looking ­to participate in trials, Dr. Paul Harris and his Vanderbilt team, with input from the Clinical and Translational Scientific Award (CTSA) consortium of academic medical centers, created ResearchMatch in 2009.{3} ResearchMatch is a pathway for the public to be connected with researchers, learn about their studies, and get involved, thereby accelerating the completion of trials and promoting the translation of discoveries into treatment.

ResearchMatch receives funding from the National Center for Advancing Translational Sciences within the National Institutes of Health (NIH), but is not specific to the study of any one disease or the work of any one institution. Rather, investigators nationwide share recruitment messages about a multitude of

research topics, such as endocrine and cardiac disorders, rare diseases, and behavioral issues. More than 135,000 people have registered as prospective volunteers on ResearchMatch to be contacted and, if appropriate, be matched to studies. Currently 98% of the volunteers have been contacted with a study opportunity at least once, and of those volunteers, 59% say “Yes, I am interested.”

Support Across the Nation

Asking, listening, and responding to the needs of our audience, changes in the U.S. census, and NIH mandates are paramount to ensuring that the ResearchMatch website is used and is useful.{4,5} Likewise, the development and evolution of new technical features is essential to the sustainability of a scalable and adaptive platform. With institutional review board (IRB) oversight, these additions have included:

· Dissemination of REDCap surveys on behalf of the researchers

· Development of the Trials Today clinical trial search engine

· Integration of Trials Today and ResearchMatch on the volunteer dashboard

· Spanish translation of the ResearchMatch website

Sustainability of this resource is contingent upon enabling a diverse community of volunteers, researchers, and institutional liaisons to use ResearchMatch to its fullest potential, and raising awareness of ResearchMatch as the place to learn about research opportunities and enroll in approved studies. Vanderbilt University Medical Center (VUMC) hosts ResearchMatch, and its IRB provides human subjects protection oversight for the overall project, but specific studies recruiting through ResearchMatch receive approval from their own site-based IRBs or the IRB of record.

The coordinating team at VUMC engages with researchers and liaisons via monthly webinars and team calls, and provides support via the info@researchmatch.org mailbox. Community events, e-mail, newsletters, social media, and webinars are among the primary methods for engaging volunteers.

The national liaison team is the backbone of ResearchMatch, and is comprised of research administrators, IRB professionals, and recruitment experts from the foremost research facilities in the United States. Not only do the liaisons teach researchers how to use ResearchMatch, they engage with the community and promote use of the platform. Through the promotional efforts of these liaisons, such as handing out brochures at church health fairs and listing the service on their institutions’ websites, volunteers find their way to ResearchMatch.

The Network and Volunteers

Each day, new volunteers join ResearchMatch and share information about themselves, including on their demographics, health conditions, medications, and how far they are willing to travel to join a study. By registering, a volunteer essentially raises his or her hand to say “I want to be informed about studies that need my help.”

Volunteers’ data are securely stored on web servers maintained within the Vanderbilt firewall. All data sent between web server and browsers are encrypted using Secure Sockets Layer protection. Furthermore, all identifiable health and contact information is stored within the database in encrypted format, and never released unless the volunteer specifically gives approval to be contacted by the researcher for a particular study.

The platform is freely available for use by researchers from nonprofit institutions in the ResearchMatch network. Joining the network requires that the institution sign a legal document and assign at least one institutional liaison to coordinate the local IRB’s involvement, and to support researchers’ and participants’ awareness of the platform. Researchers register as users through their institution’s approved portal to ResearchMatch, abide by the oversight of that institution, and agree to treat all volunteers’ identifying information as confidential.

ResearchMatch Creates Connection

Researchers with IRB approval to use ResearchMatch and IRB-approved recruitment language register their studies with the system. Before messaging potential participants, the researcher creates a cohort of de-identified individuals who meet inclusion and exclusion criteria specific to the registered study with geographic, demographic, health condition, and medication filters supported by Boolean logic.

The researcher then submits the IRB-approved contact message and may submit an IRB-approved survey, which ResearchMatch sends to the still de-identified volunteers. Volunteers who wish to be contacted by the researcher release their information via a secure dashboard, and the researcher responds to them in a timely manner.

As of the time this column was being written in late 2018, tens of thousands of people had been enrolled in studies with the help of this resource, resulting in 363 publications associated with registered studies. ResearchMatch will continue to develop and grow to support and raise awareness of ways to be involved in research advancements in medicine and improve well-being for everyone.

References

1. Carlisle B, Kimmelman J, Ramsay T, MacKinnon N. 2015. Unsuccessful trial accrual and human subjects protections: an empirical analysis of recently closed trials. Clin Trials 12(1):77–83. doi:10.1177/1740774514558307.

2. Roberts J, Waddy S, Kaufmann P. 2012. Recruitment and retention monitoring: facilitating the mission of the National Institute of Neurological Disorders and Stroke (NINDS). J Vasc Interv Neurol 5(supp):14–9.

3. Harris PA, Scott KW, Lebo L, Hassan N, Lightner C, Pulley J. 2012. ResearchMatch: a national registry to recruit volunteers for clinical research. Acad Med 87(1):66–73. doi:10.1097/ACM.0b013e31823ab7d2.

4. U.S. Census Bureau. 2018. Quick Facts United States: Population Estimates (July 1, 2017). https://www.census.gov/quickfacts/fact/table/US/PST045217

5. NIH policy and guidelines on the inclusion of women and minorities as subjects in clinical research: amended. 2001. Public Health Service Act sec. 492B, 42 U.S.C. sec. 289a-

Loretta M. Byrne, RN, MS, CCRP, (loretta.byrne@vumc.org) is a Research Services Consultant III at the Vanderbilt Institute for Clinical and Translational Research and the Project Manager for ResearchMatch.