Using registries to recruit subjects for clinical trials☆
Introduction
Clinical trials are needed to translate basic research findings to clinical practice. Most of these prospective trials face the major challenge of recruiting subjects (as determined by sample size calculations) needed to test the study hypothesis. Not only do trials need to recruit the number of subjects who meet study entry criteria, they must recruit them in a timely manner and within budget. In the United Kingdom (UK) fewer than one third of trials achieved their target recruitment number and half required an extension period for recruitment [1]. In the United States (US) there were enrollment delays in 90% of clinical trials with 30% under-enrolling and only 7% of sites recruited the projected number of participants [2]. More recently, of 6279 cardiovascular clinical trials in ClinicalTrials.gov 10.9% were terminated early. Of these 53.6% occurred because of low recruitment of subjects [3]. Failure to recruit in a timely manner can have many scientific, economic and ethical consequences [4].
Current recruitment methods (Fig. 1) include, but are not limited to, referrals (from physicians/clinics), rounds (at medical/clinic rounds), information sessions (for patients/community groups), advertisements (in radio/television/newspapers/Internet/social media), electronic health records, and registries (disease/patient) [5]. Each method has its strengths and weaknesses with success rate often depending on the study.
Registries are organized databases developed for specified clinical, scientific or policy purposes [6]. Depending on the type of registry (patient, disease, product, administrative, quality improvement, etc.), its data elements, structure and terminology may vary. Patient/disease registries usually contain demographic data, diagnoses and treatment details of patients with the disease, all collected in a systematic and uniform manner to serve a pre-determined purpose. They may be used to answer specific research questions, map out the natural history of a disease, assess the quality of care, track patients in medical practices, and collect post-marketing safety data, as required by regulatory agency, in patients taking new medications or using new devices. Often not developed for recruiting subjects for specific clinical trials, patient/disease registries can be used to identify potential subjects for clinical trials, especially for large, multicenter clinical trials or clinical trials involving patients with rare diseases or ethnic minorities. Such registries, when linked with health record information on study entry criteria, become “research” registries that can facilitate recruitment, making it more efficient and increasing the likelihood of success [7]. In November 2009 the National Institutes of Health (NIH) announced the first US research study recruitment registry (ResearchMatch) as one of the strategies to meet the recruitment challenge for clinical trials in the US [8], [9].
Our study examines the use of patient/disease registries to identify, screen for eligibility and recruit potential subjects for clinical trials published during the decade of 2004–2013 — describing how many registries were used, the types of registries used, the aims of the clinical trials, and the major benefits of using this approach. The focus is only clinical trials, not all clinical research.
Section snippets
Methods
We conducted focused database searches in EMBASE, PubMed, and Web of Science for studies that acknowledged using disease/patient registries to recruit potential subjects for clinical trials. For each search, a set of ‘registry’ keywords (“registries”, “registry”, “register”) were combined with a set of ‘recruitment’ keywords (recruitment and its variations) using the Boolean operator ‘AND’. In addition to keywords, appropriate controlled vocabulary terms (registries [majr:noexp], patient
Number of citations identified
Of these 233 citations, 21 studies are identified as using patient/disease registries to recruit subjects for clinical trials — 10 papers (Table 1) and 11 abstracts (Table 2). From the references of all 10 papers, pearling identified 3 new papers — 2 were clinical trials [13], [14] and 1 disease-neutral registry [15] used to recruit subjects for clinical trials. One full paper [16] of an abstract [17] from the initial search was found. In our analysis the 10 papers from the initial search, the
Discussion
Our study shows that many types of registries have been used to identify, screen and recruit potential subjects for many types of prospective clinical trials to uncover many aspects of new knowledge in many diseases. Types of registries included population-based cancer registries, quality improvement registry, disease-specific registries, local general practice registers, national health database, and web-based disease-neutral registries. The wide spectrum of diseases includes cancer, diabetes,
Conclusion
Our findings demonstrated that many types of registries have been used to identify, screen and recruit potential subjects for many clinical trials. Registries, being large databases, can very quickly and efficiently identify large number of potential subjects for a clinical trial. They have been and should be used more often to identify subjects for prospective clinical trials leading to more timely recruitment of subjects. In so doing, they can help solve the most critical problem of clinical
Acknowledgments
We wish to acknowledge Michelle Bass, Taubman Health Sciences Library, University of Michigan, for her data collection efforts. We also wish to thank Dr. William Herman of University of Michigan for reviewing the manuscript.
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The project described was supported by grant number P30DK020572 (MDRC) and Matthew Thomas' studentship was supported by T32DK007245 both from the National Institute of Diabetes and Digestive and Kidney Diseases.