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Regulatory Implications Of Inadequately Designed Pimavanserin Drug Trials Published With Risk Of Bias On Expedited Regulatory Approval Processes, Benson Law May 2023

Regulatory Implications Of Inadequately Designed Pimavanserin Drug Trials Published With Risk Of Bias On Expedited Regulatory Approval Processes, Benson Law

Electronic Thesis and Dissertation Repository

The objective of this retrospective critical appraisal study was to determine if the trials submitted to the Food and Drug Administration for the expedited approval of pimavanserin was of sufficient methodological quality to ascertain its safety and efficacy. After the general metrics of the trials were assessed, the Risk of Bias 2 tool and the PRagmatic Explanatory Continuum Indicator Summary tool were employed to evaluate the risk of bias and the design suitability of the trials. This study suggests that the decision to approve pimavanserin for the treatment of Parkinson’s Disease Psychosis failed to meet the threshold of evidence normally …


Survival Rates And Clinical Trial Participation Among Rural Cancer Patients, Tatiana Kurilo Jan 2023

Survival Rates And Clinical Trial Participation Among Rural Cancer Patients, Tatiana Kurilo

Walden Dissertations and Doctoral Studies

The literature indicates that cancer patients in rural areas lack adequate access to clinical trials and may experience more harmful consequences than patients residing in urban areas. The purpose of the study was to compare cancer survival rates among patients living in rural and urban counties in a southeastern U.S. state with breast cancer and lung cancer. Analysis was conducted using secondary data from the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) Program tumor registry, Comprehensive Cancer Center (CCC) tumor registry, and CCC OnCore Subject Accrual Data. A series of independent samples t-tests and factorial ANOVA were conducted …


Survival Rates And Clinical Trial Participation Among Rural Cancer Patients, Tatiana Kurilo Jan 2023

Survival Rates And Clinical Trial Participation Among Rural Cancer Patients, Tatiana Kurilo

Walden Dissertations and Doctoral Studies

The literature indicates that cancer patients in rural areas lack adequate access to clinical trials and may experience more harmful consequences than patients residing in urban areas. The purpose of the study was to compare cancer survival rates among patients living in rural and urban counties in a southeastern U.S. state with breast cancer and lung cancer. Analysis was conducted using secondary data from the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) Program tumor registry, Comprehensive Cancer Center (CCC) tumor registry, and CCC OnCore Subject Accrual Data. A series of independent samples t-tests and factorial ANOVA were conducted …