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There are several reasons why institutions should place greater emphasis on patient recruitment. First and foremost, hospitals, academic medical centers and other medical institutions involved in clinical research strive to advance science and improve the quality of health care. Without the appropriate participant population in a study, the results will not reach the public.
Institutions also must recognize that advanced recruitment capabilities can lead to more revenue. In a sponsor-initiated research study, institutions receive dollars for every patient enrolled. The formula is simple: more patients equals more dollars. The revenue covers the costs of the study but can also contribute to funding additional research infrastructure and growing the research enterprise.
Sponsors prefer to partner with institutions that can deliver. Institutions with a track record of meeting and/or exceeding enrollment targets are more likely to attract sponsored studies. This leads to additional fiscal return on investment and increased participation in breakthrough research studies. It’s a beneficial cycle that all leads back to recruitment.
However, recruitment does not have to be a challenge. Developing a recruitment plan with the following in mind, can significantly improve the odds of success.
Enhance the feasibility process
The feasibility process offers study teams an opportunity to critically examine their ability to carry out a protocol prior to committing to a study. Accurately assessing whether a team can meet the objectives of the protocol and deliver research results is key to success. Instead of asking investigators whether they expect to meet enrollment targets, institutions should implement processes to perform a true analysis of patient population. This can be done through using an electronic medical record (EMR) system and ICD-9/ICD-10 codes as a search mechanism for identifying patients who might fit the criteria, or by utilizing some sort of database or other technology.
Penn Medicine, part of the University of Pennsylvania Health System, is using its EMR to aid in patient recruitment for clinical research. At Penn Medicine, participant criteria can be “embedded as an alert in the ambulatory EMR,” and “if a patient matches the criteria, his or her doctor gets a message on the patient’s EMR screen.” (2)
Using technology for clinical trials recruitment
Like Penn Medicine, many institutions are using database technology for recruiting purposes. Databases allow institutions to determine high-level eligibility criteria, submit requests, run queries and generate reports that assist in recruitment decision-making. Some institutions promote using a clinical detection intelligence system (CDIS) that interfaces with electronic medical records and enables eligibility criteria logic to be programmed into the EMR system. This allows institutions to receive alerts and study teams to be notified when patients meet eligibility criteria. (3)
Other institutions opt for a separate recruitment database. Washington University in St. Louis has long been at the forefront of this effort, building a comprehensive participant registry database that houses information about patients and healthy volunteers who would consider participating in a research trial. This proactive measure allows the school to collect information on potential participants and salient characteristics such as disease type and medications. The database’s search capabilities make it simple to identify whether a particular study has enough qualified participants. (4)
Social media also has a role to play in recruitment. Institutions can use Facebook, Twitter and others to not only spread the word about research, but also to build a community of individuals who might be interested in becoming a participant. Debi Brooks, Co-Founder of the Michael J. Fox Foundation, which funds research aimed at finding a cure for Parkinson’s disease, says, “One of the biggest challenges is the slowness of recruitment to clinical trials.”
To overcome this challenge, Brooks developed a system she calls “a Match.com for Parkinson’s patients.” (5) Patients provide information that recruiters can sift through to find potential fits. All information is de-identified. ResearchMatch, a collaboration of more than 60 research institutions affiliated with the Clinical and Translational Science Awards (CTSAs), is another such system. (6) The benefits are clear: as of January 2012, “Over 119,900 ResearchMatch study invitations have been sent to our volunteers and over 2,400 volunteers have been enrolled in studies.” (7)
Strengthening roles and responsibilities for the recruitment process
Many large academic medical centers and health system hospitals, primarily those who are CTSA recipients, advocate developing a recruitment core. The core helps study teams identify participants for trials and also manages any recruitment database or related technology. At Washington University in St. Louis, studies were reaching, on average, only 60% of the enrollment targets. The development of the Recruitment Enhancement Core helped studies reach 125% enrollment during the pilot period. (8)
Regardless of whether institutions opt for this route, they should define roles and responsibilities better throughout the process. Who is responsible for identifying target participants? Who is responsible for initial screening? Does everyone with a role have the appropriate training necessary to carry out their responsibilities? These are the types of questions institutions must ask themselves in designing an efficient recruitment process. Without a process, recruitment becomes everyone’s responsibility and therefore no one’s responsibility.
It can be argued that recruitment is the most important key to a successful clinical research study, and it can no longer be placed on the back burner of the research process. Critical analysis at the onset of every study and proactive measures to attract and recruit participants are essential. Without human subjects to test new scientific discoveries, those discoveries will never impact the quality of care available to the public.
Jim Moran and Erika Stevens are part of Ernst & Young’s Clinical Research Team within the Health Care Advisory Practice.
The views expressed herein are those of the authors and do not necessarily reflect the views of Ernst & Young LLP.