Objective: To review the scope of interventional trials for Parkinson disease registered on clinicaltrials.gov in the past 10 years.

Background: Parkinson disease (PD) is a broad chronic condition with variable manifestations and different paths to clinically meaningful disability. In general, clinical trials in PD aim to advance novel therapeutics through a wide variety of approaches. In an environment with a limited number of eligible PD trial participants however, it may be reasonable to consider whether clinical trials can and should confirm to the ordinal research priorities of the PD community, including patients, caregivers, and researchers. Since 2007, the Federal Drug administration (FDA) has required interventional clinical trials occurring in the US to be registered on the website clinicaltrials.gov.

Methods: Using the search term “Parkinson disease” and the trial subtype “interventional trials”, we reviewed all resultant studies catalogued on clinicaltrials.gov between 1/1/2006 and 8/1/2016. Our initial search retrieved 1226 studies, 1157 of which were determined to be relevant to Parkinson disease. Using descriptive statistics, we reviewed these trials and categorized their characteristics.

Results: Trials studying drugs 59.12% (n=681) were the most common, followed by trials for devices 19.97% (n=231), behavioral modifications 8.21% (n=95), physical activity 10.71% (n=124), and access to care 1.30% (n=15).  Of the funding sources, industry and single medical center or universities were the most common comprising 42.44% (n=491) and 42.18% (n=488) of the funding respectively. Other sources included federal (8.47%, n=98), foundations (8.30%, n=96), nonprofit organizations (2.33%, n=27), and research institutes (1.77%, n=21). The majority of PD trials were randomized (68.71%). Less than half were placebo controlled (44.86%). Blinding/Masking was performed in 60.85% of studies; of these, 21.86% were single blind and 78.13% were double blind.

Conclusions: Less than 20% of PD trials receive federal/foundation funding—raising the possibility that the vast majority of all PD trials and per-person-effort by PD trial participants are not on protocols subject to pre-funding peer review. We aim to use this dataset to further explore other properties of PD trials to better understand concordance and mismatches between PD trial designs and published PD community research priorities.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/the-landscape-of-interventional-trials-in-parkinson-disease-a-10-year-review-of-clinicaltrials-gov-between-2006-and-2016/