Experience With Direct-to-Patient Recruitment for Enrollment Into a Clinical Trial in a Rare Disease: A Web-Based Study

Jeffrey Krischer, Peter F Cronholm, Cristina Burroughs, Carol A McAlear, Renee Borchin, Ebony Easley, Trocon Davis, Joyce Kullman, Simon Carette, Nader Khalidi, Curry Koening, Carol A Langford, Paul Monach, Larry Moreland, Christian Pagnoux, Ulrich Specks, Antoine G Sreih, Steven Ytterberg, Peter A Merkel, Vasculitis Clinical Research Consortium, Jeffrey Krischer, Peter F Cronholm, Cristina Burroughs, Carol A McAlear, Renee Borchin, Ebony Easley, Trocon Davis, Joyce Kullman, Simon Carette, Nader Khalidi, Curry Koening, Carol A Langford, Paul Monach, Larry Moreland, Christian Pagnoux, Ulrich Specks, Antoine G Sreih, Steven Ytterberg, Peter A Merkel, Vasculitis Clinical Research Consortium

Abstract

Background: The target sample size for clinical trials often necessitates a multicenter (center of excellence, CoE) approach with associated added complexity, cost, and regulatory requirements. Alternative recruitment strategies need to be tested against this standard model.

Objectives: The aim of our study was to test whether a Web-based direct recruitment approach (patient-centric, PC) using social marketing strategies provides a viable option to the CoE recruitment method.

Methods: PC recruitment and Web-based informed consent was compared with CoE recruitment for a randomized controlled trial (RCT) of continuing versus stopping low-dose prednisone for maintenance of remission of patients with granulomatosis with polyangiitis (GPA).

Results: The PC approach was not as successful as the CoE approach. Enrollment of those confirmed eligible by their physician was 10 of 13 (77%) and 49 of 51 (96%) in the PC and CoE arms, respectively (P=.05). The two approaches were not significantly different in terms of eligibility with 34% of potential participants in the CoE found to be ineligible as compared with 22% in the PC arm (P=.11) nor in provider acceptance, 22% versus 26% (P=.78). There was no difference in the understanding of the trial as reflected in the knowledge surveys of individuals in the PC and CoE arms.

Conclusions: PC recruitment was substantially less successful than that achieved by the CoE approach. However, the PC approach was good at confirming eligibility and was as acceptable to providers and as understandable to patients as the CoE approach. The PC approach should be evaluated in other clinical settings to get a better sense of its potential.

Keywords: clinical trial; direct-to-consumer advertising; granulomatosis with polyangiitis; research subject recruitment; social media.

Conflict of interest statement

Conflicts of Interest: None declared.

©Jeffrey Krischer, Peter F Cronholm, Cristina Burroughs, Carol A McAlear, Renee Borchin, Ebony Easley, Trocon Davis, Joyce Kullman, Simon Carette, Nader Khalidi, Curry Koening, Carol A Langford, Paul Monach, Larry Moreland, Christian Pagnoux, Ulrich Specks, Antoine G Sreih, Steven Ytterberg, Peter A Merkel, Vasculitis Clinical Research Consortium. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 28.02.2017.

Figures

Figure 1
Figure 1
The Assessment of Prednisone in Remission (TAPIR) study summary for center of excellence (CoE) and patient-centric (PC) arms.
Figure 2
Figure 2
Patient-centric (PC) arm study flow.
Figure 3
Figure 3
The Assessment of Prednisone in Remission (TAPIR) trial consort diagram.

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