The Michael J. Fox Foundation for Parkinson’s Research (MJFF) aims to speed clinical research by removing obstacles that stand in the way of drug development. In pursuit of this mission, the Foundation gathers insights from a wide range of stakeholders and uses these perspectives to enhance clinical trial processes from start to finish. In

Applied Clinical Trials

’ Eye on Patient Advocacy series, we will share best practices and lessons learned from the field of Parkinson’s research that can be applied to clinical trials across disease states. In our fifth column in this series, we explore the use of a ride-sharing service to reduce transportation barriers for research participation.

Background

In January 2017, The Michael J. Fox Foundation launched a survey to assess the need for transportation infrastructure at clinical trial sites. Using Fox Trial Finder, MJFF’s online clinical trial matching tool, 843 clinical trial sites in the U.S. were contacted to understand how transportation access impacts participant recruitment, and what kind of transportation participants would find most helpful. Of the 49 sites that responded, 95% reported that transportation infrastructure would improve recruitment efforts, and 63% felt it would ensure all studies recruited on time. Eighty-four percent of respondents reported that a taxi, livery, or ride-sharing service partnership would be the preferred transportation infrastructure.

Data from the survey was used to inform the design of a transportation intervention that was tested via the Parkinson’s Disease Trial Recruitment Innovation (PD-TRI) project, an MJFF-funded pilot study aimed at reducing barriers and enhancing facilitators to clinical trial recruitment.

Methods

Sample

To participate in PD-TRI, project sites had to be based in the U.S., be geographically diverse, and have large clinical research portfolios. One of the three selected sites, Beth Israel Deaconess Medical Center (BIDMC) in Boston, MA, elected to implement a partnership with a ride-sharing service. The study principal investigators, Samuel Frank, MD, and David K. Simon, MD, PhD, felt that providing round-trip transportation to research appointments would alleviate stress and logistical challenges for study participants (e.g., finding parking, relying on a care partner for transportation, transportation costs).

Materials

BIDMC used a template to collect data on the cost of the service and the coordinator time required to arrange it, and assess the impact of the transportation service on recruitment. BIDMC also used a study satisfaction survey to gather insights on participants’ experience in the study and use of the transportation service. (To view and download an example of a study satisfaction survey, visit michaeljfox.org/ResourcePack)

Design and procedures

To partner with a ride-sharing service, BIDMC signed a terms-of-service agreement and implemented a payment system. To use the service, coordinators worked with each study participant to determine a pickup location. The coordinator then arranged the ride in advance using a simple web portal. This removed the need for study participants to have a smartphone or online connection. After completing the ride, the ride service could either charge an institutional credit card or send a monthly invoice to the clinical trial site, thereby removing the stress or logistics of reimbursement from the study participant.

To protect patient privacy, the ride service allows sites to provide an alias or only the patient’s first name when requesting rides. If a site happens to provide a person’s full name, the driver receives only the first name and last initial. Moreover, passenger information disappears from the driver’s phone once the ride is complete. To ensure the ride-sharing service was ethical and compliant with patient privacy regulations, BIDMC developed a protocol describing the service that was approved by its institutional review board (IRB).

Data collection

After a preliminary phone screening to determine study eligibility, individuals were offered rides via the ride service. Data on individual acceptance of transportation, cost and timeliness of rides, and coordinator time spent arranging rides were collected via the template. Participants filled out a study satisfaction survey at their baseline visit to assess the impact of transportation on their decision to enroll in the study.

Results

Data from the BIDMC and ride-sharing partnership are provided in Table 1 and Figure 1. Data from only one BIDMC study are provided, as recruitment for other studies was limited during the PD-TRI study.

Discussion

Results provide insights into the impact of providing transportation on clinical trial recruitment efforts:

• Individuals who live farther from the clinical trial site seem more likely to accept rides, indicating that transportation infrastructure may help clinical trial sites engage with harder to reach populations and broaden their recruitment networks.

• While providing transportation may seem expensive, the average round trip cost (two rides) is $96.37. This figure is quite small in comparison to the average total costs of a Phase III clinical trial (between US $11.5 million [dermatology] and US $52.9 million [pain and anesthesia]).¹

• Coordinators spend a minimal amount of time and effort to coordinate rides, and from the patient satisfaction surveys, this service appears to provide a great amount of benefit to study participants. Providing this service may help mitigate study attrition.

• Although study participants indicated that they likely would have participated in the current clinical study even without being offered transportation, they responded very positively to the service, with all participants reporting that the rides made it easier for them to attend appointments. This suggests that the provision of transportation could improve participant retention in a study. Also, 90% of respondents agreed or strongly agreed that they would be more likely to participate in another study in the future if transportation were provided. This indicates that providing transportation not only helps recruitment, but also is an asset for long-term community engagement.

• Third-party ride services can be used in a manner that protects participant confidentiality.

Key considerations for sites contemplating transportation partnerships

• Clinical sites seeking to establish a partnership with a transportation service should request contractual materials from the potential partner, share these with internal grants administrators for review, and seek IRB approval.

• Factor in additional time prior to study start-up for contract negotiations and testing any software or processes associated with the partnership. An institution-wide contract with a ride-sharing service may take significantly longer to implement than one for a single study.

• Develop detailed protocols that determine when and how often individuals will be offered rides, and whether they will be offered transportation for visits throughout the full duration of the study.

• Create systems to evaluate your transportation service and determine how it impacts recruitment at your site.

To learn more about this transportation pilot, read the “Transportation Innovation to Aid Parkinson’s Disease Trial Recruitment” publication in Contemporary Clinical Trials Communications, accessible at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6804741/.²

References

1. Sertkaya, A, et al. “Key cost drivers of pharmaceutical clinical trials in the United States.” Clin Trials. 2016 Apr;13(2):117-26. doi: 10.1177/1740774515625964. Epub Feb 8, 2016.

1. Frank, S, et al. “Transportation innovation to aid Parkinson disease trial recruitment.” Contemp Clin Trials Commun. 2019 Sep 10;16:100449. doi: 10.1016/j.conctc.2019.100449. eCollection Dec 2019.

The MJFF Research Engagement Team includes James Gibaldi, MS, Associate Director; Tara Hastings, Senior Associate Director; Catherine M. Kopil, PhD, Director; Bernadette Siddiqi, MA, Associate Director; and Michelle Whitham, Research Partnerships Officer; all at The Michael J. Fox Foundation in New York, NY. To contact the MJFF Research Engagement Team, email: trialsupport@michaeljfox.org

MJFF would like to acknowledge the following individuals for their contribution to the research presented in this case study: Samuel Frank, MD, David K. Simon, MD, PhD, Laura Hernandez, Holly Shill, MD, Penelope Hogarth, MD, and Sarah Berk, MPH.