Session Information
Date: Thursday, June 23, 2016
Session Title: Clinical trials and therapy in movement disorders
Session Time: 12:00pm-1:30pm
Location: Exhibit Hall located in Hall B, Level 2
Objective: The objective of the project was to design a durable tool, usable by clinical trial investigators and participants alike, that would improve subject retention in PD trials.
Background: Clinical trials fail for many reasons, often unrelated to the trial medication itself. These failures may be avoidable if the reasons are identified and addressed. The present study sought: (a) to identify causes by surveying the stakeholder population, (b) to establish a course of action.
Methods: An online survey of people with PD (PwPs) and clinicians (304 participants) was used to identify barriers to success in clinical trials among the two communities. These were addressed in focus groups and actionable barriers were distilled into best practice recommendations. These recommendations were further distilled into a fact sheet for wider circulation.
Results: The online survey identified the top three barriers to success in clinical trials in PD among clinicians: funding (66%), administrative support (46%), and recruitment of patients to trials (44%). For PWPs, the top reasons were: potential adverse/side effects (58%), disruption of existing medication (53%), risk of placebo (39%), general upheaval (38%) and lack of information on progress and results of trial (34%). Many of these are communication issues and thus constituted actionable barriers. These were discussed in focus groups drawn from 110 patient conference participants and instigated development of a clinical trials charter for use by those considering participating in, or conducting, PD clinical research. The charter has been developed internationally by PwPs, in consultation with PD advocates, PD clinical trials specialists and key PD patient organisations. It is a simple two-sided document outlining standards of practice and reasonable expectations for participants and researchers. Accompanying resources, including a range of leaflets and informative film, have also been developed.
Conclusions: The charter will be evaluated in an upcoming RCT of simvastatin as a neuroprotective agent in PD, by means of participant surveys, to understand its potential role in supporting recruitment and retention in PD trials.
To cite this abstract in AMA style:
C. Carroll, I. Tom, M. Helen, S. Jon. A clinical trials ‘charter’ to improve communication about, recruitment to and retention in Parkinson’s clinical trials [abstract]. Mov Disord. 2016; 31 (suppl 2). https://www.mdsabstracts.org/abstract/a-clinical-trials-charter-to-improve-communication-about-recruitment-to-and-retention-in-parkinsons-clinical-trials/. Accessed May 24, 2025.« Back to 2016 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/a-clinical-trials-charter-to-improve-communication-about-recruitment-to-and-retention-in-parkinsons-clinical-trials/