LEARN-ATMP
Research type
Research Study
Full title
LEARN-ATMP – using the patient voice to develop a framework for accessible ATMP trials
IRAS ID
327211
Contact name
Cheney Drew
Contact email
Sponsor organisation
Cardiff University
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Study Rationale: New therapies for Parkinson’s disease have been developed that involve cells or genes being put directly into the brain. Before they can be used as treatments, we need make sure they work using large studies known as clinical trials. These investigations need people with Parkinson’s to take part, but they can be very challenging for the participants. As the trials move forward, they are likely to need greater numbers of participants and will require life long follow-up, making it even more difficult for participants. The LEARN team (Listening to the Experience of pARticipants on Neurosurgical trials) have interviewed some participants in studies like this before to learn about their experiences, but only several years after the trial. We believe it is important to talk to people about their experience during a trial to get as detailed an understanding as possible of the issues facing people with Parkinson’s taking part in trials of advanced therapies.
Aim: We hope that by understanding the participant experience during trials of cell therapy we can improve cell therapy trials in Parkinson’s by providing guidance to people designing the trials and information for those asked to take part.
Study Design: We will interview the participants and care partners of the STEM-PD stem cell trial being conducted between the UK and Sweden. Participants will be interviewed before the stem cell transplant and 2 times during the follow-up period of the STEM-PD trial. We will also interview participants and care partners of those in the TRANSEURO cohort who have had a fetal cell transplant or have been approached to take part in STEM-PD but are unable or do not want to take part.
Impact on Diagnosis/Treatment of Parkinson’s disease: These results will be used to develop a framework for improved design and conduct of patient-centered trials. We will identify ways to keep participants engaged in long-lasting trials, and make them more widely accessible to the Parkinson’s community. In doing this we hope that effective treatments will be available to people with Parkinson’s more quickly.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
23/EM/0249
Date of REC Opinion
6 Dec 2023
REC opinion
Further Information Favourable Opinion