title: Which patients with Parkinson's disease participate in clinical trials? One centre's experiences with a new cell based therapy trial (TRANSEURO).
abstract: BACKGROUND
  There is currently little evidence regarding the selection of patients for clinical trials in Parkinson's Disease (PD), especially those involving experimental therapies delivered using invasive techniques.
  
  
  OBJECTIVE
  Understanding which patients are recruited will increase awareness of issues regarding parity of access to clinical trials and have an impact on the wider applicability of results, as well as provoking discussion regarding future improvements in the enrolment process.
  
  
  METHODS
  TRANSEURO is an open label multi-centre surgical transplant trial which seeks to investigate the feasibility and efficacy of grafts of human foetal ventral mesencephalic tissue in patients with PD. The Cambridge based cohort of TRANSEURO participants (n = 26) was compared with a population representative sample of patients with PD eligible for, but not enrolled in, TRANSEURO (n = 33). Measurements were available in both populations for demographics, neuropsychological tests, tests of motor and non-motor function and quality of life.
  
  
  RESULTS
  Patients enrolled in TRANSEURO were younger and had significantly more years of education with higher scores on the revised Addenbrooke's Cognitive Examination. This difference was accounted for by memory, fluency and visuospatial subscores. There were significant differences in the Movement Disorder Society Unified PD Rating Scale scores with better motor function but more motor complications in the enrolled group. Those enrolled were also more likely to be under the care of the principal investigator of the study.
  
  
  CONCLUSIONS
  In this trial our population was younger and more educated with higher cognitive scores and better motor function than eligible PD patients not enrolled. This raises interesting questions about the parity of access to clinical trials of this nature amongst patients with PD.
authors.affiliation: John Van Geest Centre for Brain Repair, University of Cambridge, Forvie Site, Robinson Way, Cambridge, UK.
authors.forename: Sarah F
authors.initials: SF
authors.lastname: Moore
authors.affiliation: John Van Geest Centre for Brain Repair, University of Cambridge, Forvie Site, Robinson Way, Cambridge, UK.
authors.forename: Natalie Valle
authors.initials: NV
authors.lastname: Guzman
authors.affiliation: John Van Geest Centre for Brain Repair, University of Cambridge, Forvie Site, Robinson Way, Cambridge, UK.
authors.forename: Sarah L
authors.initials: SL
authors.lastname: Mason
authors.affiliation: John Van Geest Centre for Brain Repair, University of Cambridge, Forvie Site, Robinson Way, Cambridge, UK.
authors.forename: Caroline H
authors.initials: CH
authors.lastname: Williams-Gray
authors.affiliation: John Van Geest Centre for Brain Repair, University of Cambridge, Forvie Site, Robinson Way, Cambridge, UK Department of Neurology, Addenbrooke's Hospital, Cambridge, UK.
authors.forename: Roger A
authors.initials: RA
authors.lastname: Barker
mesh_terms: D000328:Adult; D000368:Aged; D064987:Cell- and Tissue-Based Therapy / Q000379:methods*; D015331:Cohort Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009043:Motor Activity / Q000502:physiology; D009483:Neuropsychological Tests; D010300:Parkinson Disease / Q000150:complications / Q000628:therapy*; D011569:Psychiatric Status Rating Scales; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
keywords: Parkinson disease; cell- and tissue-based therapy; clinical trials as topic; neurodegenerative diseases; patient participation