Research On The Risk Management In The Clinical Implementati On Phase Of Bioequivalence Trials

Background and objective Bioequivalence trial is an important part of consistency evaluation.Lack of understanding of the risks of the bioequivalence trial may affect the progress and quality of the trial,and may increase the cost,or even lead to the non-equivalent results.This study aims to decompose the clinical process of the bioequivalence trial,establish the risk assessment system 、 put forward the corresponding countermeasures for CRO/SMO,Sponsers,Ethics/Clinical trials management,The Investor team and the related part of the trial.Methods This research first systematically sorted out the current research status of bioequivalence trial risk management at home and abroad,collected project quality control reports,audit reports and other relevant data to analyze the risk factors in the current trial,and introduced Failure Modes and Effect Analysis(FMEA)to identify bioequivalence trial risks.Conducted risk assessment of the severity,occurrence,and undetectability of the risk through questionnaires and Action Priorities(AP)in the hazard analysis(CA)in the implementation stage.Results This study identified 37 failure modes in the clinical implementation phase of the bioequivalence trial and analyzed the reasons for their formation and the impact on the quality of the trial;Obtained the risk ranking of each failure mode in the clinical implementation stage of the trial.Among the risk points that the CRO/SMO side focuses on are the personnel management,safety management,and biological sample collection risks;the sponsor focuses on the original records 、 process documents and subject management risks;the risk points that ethical and institutional managers care about are mainly focused on subject management,process records,source data management,and drug management risks;the research team focuses on the conditions and compliance management,original records and process documents,subject management risks;other relevant parties’ risk points are mainly focused on biological sample management,subject management,and safety management risks.Conclusion The FMEA analysis model of the clinical implementation stage of thebioequivalence trial has been established,and the corresponding risk prevention andresponse measures have been formulated for the different members of the trial.