Regulatory Implications of Inadequately Designed Pimavanserin Drug Trials Published with Risk of Bias on Expedited Regulatory Approval Processes
| Autor: | Law, Benson |
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| Jazyk: | angličtina |
| Rok vydání: | 2023 |
| Předmět: | |
| Zdroj: | Electronic Thesis and Dissertation Repository |
| Popis: | 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 required for FDA drug applications. It also revealed serious risks of bias with the pivotal trial that was foundational to pimavanserin’s delineation as a breakthrough drug, and that the safety studies were also questionably designed. These findings highlight the need to continue monitoring pimavanserin and re-examine expedited drug approval processes. |
| Databáze: | OpenAIRE |
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