The goal of this clinical center application is to describe the qualifications of the Parkinson's Institute as a participant in the large simple trial of neuroprotective therapy for Parkinson's disease as proposed in RFA- NS-02-010. The Parkinson's Institute has a supportive research environment, extensive clinical trials experience and highly qualified staff, together with experience in the recruitment of clinical trials volunteers and an excellent relationship with support groups. Institute staff have more than 80 years of combined experience in clinical trials, primarily investigating therapies for Parkinson's disease. The Parkinson's Institute has considerable experience in recruitment from a large patient population, through physician contacts, through support groups contacts, media and educational activities. The Parkinson's Institute has an excellent track record regarding the administrative aspects of clinical trials conduct, including subject safety, confidentiality of information, timely enrollment of subjects, timely completion of study materials and data integrity. These characteristics make the Parkinson's Institute an ideal participant in the proposed trial.
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| Wills, Anne-Marie A; Pérez, Adriana; Wang, Jue et al. (2016) Association Between Change in Body Mass Index, Unified Parkinson's Disease Rating Scale Scores, and Survival Among Persons With Parkinson Disease: Secondary Analysis of Longitudinal Data From NINDS Exploratory Trials in Parkinson Disease Long-term Study 1 JAMA Neurol 73:321-8 |
| Elm, Jordan J; NINDS NET-PD Investigators (2012) Design innovations and baseline findings in a long-term Parkinson's trial: the National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson's Disease Long-Term Study-1. Mov Disord 27:1513-21 |
