Costs of recruiting couples to a clinical trial

Abstract

Multiple barriers contribute to the slow recruitment of participants to research studies, which in turn extends the time required to translate promising scientific discoveries into proven therapeutic interventions. A small but growing literature is developing on the extraordinary costs of recruiting participants to studies, and thereby demonstrating that underestimating the cost of participant recruitment can contribute to these recruitment problems. These recruitment challenges and costs are exacerbated when the participants' study eligibility is determined by relatively narrowly defined illness parameters. Recruitment challenges are further compounded when dyads (two individuals engaged in a sociologically significant relationship, such as husbands and wives, siblings or extended families) must be recruited to an illness-focused study. For these latter groups, there are no data to guide researchers in how to anticipate those participant recruitment costs. This paper describes the staff costs for a variety of strategies used to recruit participants to a randomized supportive care study for couples who were within 18 months of a prostate cancer diagnosis. Pegged to the value of the U.S. dollar for the period, the average cost of staff time was $288 per recruited and enrolled dyad, plus a promised additional $100 incentive for study retention. Within the strategies used, the staff costs per recruited dyad ranged from $ 152 to $1,688. Accrual Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. per strategy ranged from zero to 107 enrolled couples. When asked for secondary sources of information about the study, many participants reported more than one source of study referral, reflective of the multifaceted recruitment strategies deployed. In spite of innovative, culturally competent, and broad based recruitment methods, attainment of a diverse sample was difficult to accomplish in this study. Having estimates of the actual cost of recruiting dyads to research studies can help investigators prepare realistic study budgets. NIH Public Access

Effort Required in Eligibility Screening for Clinical Trials

“…12,13,19,[26][27][28] The difference compared with our results is likely the result of differences in cost estimation methods used in the published literature, such as retrospective data capture, inclusion of nontherapeutic trials, and inclusion of recruitment-related costs (eg, advertising). Our cost estimates may also be slightly lower because there may be some efficiencies in the accrual and screening process at cancer centers through patient identification in multidisciplinary clinics.…”

“…The majority of the published literature focused on a single or limited set of studies. 13,14,[26][27][28] Finally, we used statistical methods that accounted for the ordinal nature of the effort and the multinomial distribution of the evaluation outcome, accounted for correlations in effort and evaluation outcome according to patient characteristics and other factors, and adjusted for multiple evaluations per patient. This enhances the reliability of our estimates of time and cost.…”

Challenges associated with recruiting multigenerational, multicultural families into a randomised controlled trial: Balancing feasibility with validity

“…The letters were either in English, to target parents with Anglo or Italian background (many parents with Italian background in South Australia would have been born and/or educated in Australia); or in Vietnamese (sent to parents via students attending Vietnamese language schools). This has been an effective recruitment activity in previous trials conducted by the researchers here and in Indonesia [33] and by others involved in family-based studies (e.g., [24,26]). After three weeks of full-time recruitment activities, few enquiries had been received and only three families had enrolled into the trial, two with Anglo cultural background.…”

“…Social media is a relatively recent resource for recruitment that is proving to be costeffective [36]. of the most effective recruitment activities in some previous trials with participants from different ethnic backgrounds (e.g., [21,22,26]). Table 1 outlines the overall range of recruitment activities used.…”

A Systematic Process for Recruiting Physician-Patient Dyads in Practice-based Research Networks (PBRNs)

“…Using a variety of strategies used to recruit couples in a context of prostate cancer, Sadler and colleagues 55 reported that the cost of recruiting and enrolling a couple ranged from $152 to $1,688, or an average cost of US$288. Authors of a clinical trial conducted in 1989 estimated the cost of recruiting single, healthy participants aged 25 to 49 years at US$907 per recruited participant.…”