The Value of In-Person Contact in Clinical Trials: A Qualitative Study examining Patient Attitudes towards Trial Visits conducted at a Contract Research Organisation

Abstract

Abstract BACKGROUND Decentralised clinical trials (DCTs) are those in which “some or all of a clinical trial’s activities can occur at locations other than a traditional clinical trial site”. The primary aim of this qualitative research was to establish whether a group of participants involved in patient studies at a London-based Contract Research Organisation (CRO) would prefer their trial visits to be conducted in an alternative location to the main clinical trial site. Secondary outcomes include identification of the main reasons behind participants’ preferences, whether this preference changed with the purpose of the study visit and whether patients’ perceived disease burden had an impact on their choice. METHODS Participants enrolled on patient studies at Richmond Pharmacology were surveyed when attending in-person outpatient appointments or inpatient stay admissions. Questionnaires assessed travel method to the unit, purpose of unit visit, patient perception of the utility of attending trials unit, the aspects of clinical trial participation which patients consider important and whether patients would have preferred an alternative method to conduct their visit. The EuroQol 5-Domain 5-Level descriptive system (EQ-5D-5L) was used to assess patients’ perceived disease burden. RESULTS 145 questionnaires were included in the primary analysis. 66.0% of patients indicated a score of ≥ 8/10 when asked how beneficial they considered their in-person visit to the trials unit and the most cited reason (67.6%) for this response was ‘in-person review by a research doctor’. There was no significant difference observed with a change in the nature of the visit (screening, first dosing, subsequent dosing or follow-up appointment (p = 0.361)). Patient preference for clinical trials visits to be conducted on-site versus an alternative location demonstrated no clear relationship to perceived disease burden. CONCLUSION This study has demonstrated a clear overall preference for on-site visits amongst patients attending a CRO across a variety of patient studies, the main reason being that on-site visits facilitated an in-person review by a research doctor. This study suggests that trials conducted in a centralised format are of significant value to patients and therefore careful consideration of patient preferences needs to be accounted for in future clinical trial design.