Format

Send to

Choose Destination
J Med Internet Res. 2017 Feb 28;19(2):e50. doi: 10.2196/jmir.6798.

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

Author information

1
Rare Diseases Clinical Research Network Data Coordinating Center, Health Informatics Institute, University of South Florida, Tampa, FL, United States.
2
University of Pennsylvania, Philadelphia, PA, United States.
3
Vasculitis Foundation, Kansas City, MO, United States.
4
Mount Sinai Hospital, Toronto, ON, Canada.
5
St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
6
University of Utah, Salt Lake City, UT, United States.
7
Cleveland Clinic Foundation, Cleveland, OH, United States.
8
Boston University School of Medicine, Boston, MA, United States.
9
University of Pittsburgh, Pittsburgh, PA, United States.
10
Mayo Clinic, Rochester, MN, United States.
11
Vasculitis Clinical Research Consortium, Philadelphia, PA, United States.

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

PMID:
28246067
PMCID:
PMC5350442
DOI:
10.2196/jmir.6798
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for JMIR Publications Icon for PubMed Central
Loading ...
Support Center