Barriers to clinical research participation in a diabetes randomized clinical trial

Abstract

Little is known about how barriers to research participation are perceived, affected by or interact with patient characteristics, or how they vary over the course of a clinical trial. Participants (285) in the Renin-Angiotensin System Study (RASS), a randomized clinical primary prevention study of diabetic nephropathy and retinopathy at 2 Canadiana dn 1 US university, rated potential barriers to research participation yearly for 5 years. Baseline barriers rated as most adversely affecting participation were: missing work; frequency of appointments and procedures; study length; number of appointments and procedures; access to study location; and physical discomfort associated with procedures. Inadequate social support, unstable job, and use of alcohol and drugs were cited relatively infrequently, suggesting that although they may be important, candidates for whom these might be issues likely self-selected out of the study. Gender and gender by age interactions were found for specific perceived barriers, such as work and child care, and baseline barriers correlated with adherence. Elucidating the natural history of barriers to research participation is a step toward identifying strategies for helping participants overcome them, and ultimately may enhance the conduct of research.

Participation in Clinical Research Registries: A Focus Group Study Examining Views From Patients With Arthritis and Other Chronic Illnesses

“…These findings support prior research that highlights patient preferences and demands of study participation as perceived barriers to patient participation in research (17,19,20). Importantly, Robiner et al (21) found significant correlation between protocol adherence and perceived barriers such as missing work, frequency of appointments/procedures, number of appointments/procedures, and access to study location in 978…”

Motivations of patients with pulmonary arterial hypertension to participate in randomized clinical trials

“…By contrast, most studies of willingness to participate in RCTs have addressed patients with common illnesses with multiple inexpensive therapies, such as diabetes, heart failure, or systemic hypertension [6,9,14]. These diseases are each characterized by more indolent progression, greater affordability and clearer efficacy of treatments, and greater prevalence, enriching the pool of eligible RCT participants and thereby making active-controlled trials more feasible.…”

“…In addition to these areas of divergence, the characteristics of the disease areas studied have varied considerably, from prevalent illnesses such as congestive heart failure [9] in which multiple known effective therapies exist, to rare cancers for which no known effective therapies are available [23]. Some general themes have emerged, which guide many patients’ decisions to enroll, including the time demands of the trials [6,7,14,16,18,21,24], the risks of disease recurrence or progressions [7,23], and fears of being assigned placebo [6,7,10,15,18,21]. …”

Diabetes adherence—does gender matter?

“…Most interesting is the run-in phase in which possible participants are rejected who could put the success of the study at risk, e.g., by being nonadherent (Farmer 1999). Additionally, there are many barriers to patients' participation (Ross et al 1999;Robiner et al 2009), which lead to study results not representing the comparison group in the population. As a consequence, findings based on clinical studies cannot necessarily be adapted to real-world situations.…”