Automated patient and medication payment method for clinical trials

Barbara P Yawn,¹ Suzanne Madison,¹ Susan Bertram,¹ Wilson D Pace,² Anne Fuhlbrigge,³ Elliot Israel,³ Dawn Littlefield,¹ Margary Kurland,¹ Michael E Wechsler<sup>4

1</sup>Olmsted Medical Center, Department of Research, Rochester, MN, ²UCDHSC, Department of Family Medicine, University of Colorado Health Science Centre, Aurora, CO, ³Brigham and Women's Hospital, Pulmonary and Critical Care Division, Boston, MA, ⁴National Jewish Medical Center, Division of Pulmonology, Denver, CO, USA

Background: Published reports and studies related to patient compensation for clinical trials focus primarily on the ethical issues related to appropriate amounts to reimburse for patient's time and risk burden. Little has been published regarding the method of payment for patient participation. As clinical trials move into widely dispersed community practices and more complex designs, the method of payment also becomes more complex. Here we review the decision process and payment method selected for a primary care-based randomized clinical trial of asthma management in Black Americans.
Methods: The method selected is a credit card system designed specifically for clinical trials that allows both fixed and variable real-time payments. We operationalized the study design by providing each patient with two cards, one for reimbursement for study visits and one for payment of medication costs directly to the pharmacies.
Results: Of the 1015 patients enrolled, only two refused use of the ClinCard, requesting cash payments for visits and only rarely a weekend or fill-in pharmacist refused to use the card system for payment directly to the pharmacy. Overall, the system has been well accepted by patients and local study teams. The ClinCard administrative system facilitates the fiscal accounting and medication adherence record-keeping by the central teams. Monthly fees are modest, and all 12 study institutional review boards approved use of the system without concern for patient confidentiality after reviewing all regulatory documents provided by ClinCard.
Conclusion: This system works well for studies that recruit patients from widely dispersed practices and for studies that require flexibility in the amount of payments required, eg, the cost of eight different study medications across varying insurance and pharmacy systems.

Keywords: clinical trial payment, clinical trials, ClinCard