Statistical and Ethical Implications of Pimavanserin Drug Trials Published with Unexplained or Missing Datasets on Parkinson’s Disease

This project looks to examine the safety of the medication Pimavanserin, marketed under the brand name Nuplazid. Pimavanserin is prescribed to manage Parkinson’s Disease Psychosis, a common side effect of Parkinson Disease medications. This medication has already received regulatory approval in the United Stated by the Food and Drug Administration under a special program called the “Breakthrough therapy program”. Although it initially showed promising results, concerns have been raised regarding its safety and efficacy. As such, this study will look to examine the original clinical trials that served as an evidence source for its regulatory approval, with particular attention paid on the statistical methods used to compensate for missing data. The ultimate goal is to provide Health Canada and the Canadian Agency for Drugs and Technologies in Health with more evidence to determine if this medication is safe and effective for patients with Parkinson’s Disease here in Canada.

Faculty Supervisor:

Andrew Johnson;Maxwell Smith

Student:

Partner:

Parkinson Society Southwestern Ontario

Discipline:

Life Sciences

Sector:

Other services (except public administration)

University:

The University of Western Ontario

Program: