Increasing Efficiency of Recruitment in Early Parkinson's Disease Trials: A Case Study Examination of the STEADY-PD III Trial

Journal of Parkinson's Disease
Sarah BerkTanya Simuni

Abstract

Challenges in clinical trial recruitment threaten the successful development of improved therapies. This is particularly true in Parkinson's disease (PD) studies of disease modification where the population of interest is difficult to find and study design is more complex. This paper seeks to understand how STEADY PD III, a National Institute of Neurological Disorders and Stroke (NINDS) funded phase 3 trial evaluating the efficacy of isradipine as a disease modifying agent for PD, was able to recruit their full target population 6 months ahead of schedule. STEADY PD III aimed to enroll 336 individuals with early stage idiopathic PD within 18 months using 57 sites across the United States and Canada. The study included a 10% NIH minority recruitment goal. Eligible participants agreed to be followed for up to 36 months, complete 12 in-person visits and 4 telephone visits. A Recruitment Committee of key stakeholders was critical in the development of a comprehensive recruitment strategy involving: multi-modal outreach, protocol modifications and comprehensive site selection and activation. Efforts to increase site-specific minority recruitment strategies were encouraged through additional funding. A total of 336 individuals, inclu...Continue Reading

References

Oct 3, 2013·Neurotherapeutics : the Journal of the American Society for Experimental NeuroTherapeutics·Amaal AlDakheelAnthony E Lang
Jan 5, 2014·Clinical and Translational Gastroenterology·Amit G SingalAkbar K Waljee
May 16, 2014·International Journal of Environmental Research and Public Health·Kenneth Getz
Jun 8, 2017·Annals of Clinical and Translational Neurology·Kevin M BiglanUNKNOWN Parkinson Study Group STEADY‐PD III Investigators
Aug 5, 2017·Stroke; a Journal of Cerebral Circulation·Bart M DemaerschalkUNKNOWN CREST-2 Investigators

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Citations

Mar 28, 2019·Journal of Neurophysiology·Cecilia Bove, R Alberto Travagli
Oct 22, 2019·European Journal of Neurology : the Official Journal of the European Federation of Neurological Societies·R Balestrino, A H V Schapira
Nov 6, 2020·Neurotherapeutics : the Journal of the American Society for Experimental NeuroTherapeutics·Pavan A VaswaniNabila Dahodwala
Aug 2, 2021·Contemporary Clinical Trials·Barbara C TilleyUNKNOWN additional RECRUIT Trial Center and Parent Trials' investigators

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Software Mentioned

MJFF
iTunes
STEADY
MJFF Finder

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