To standardize the management of investigator-initiated trials(IITs)involving off-label drug use,the authors use the actual situation of their hospital as an example.By strengthening discipline-specific expert consultation,integrating the management of the Pharmacy and Therapeutics Committee and the Medical Affairs Office,and refining internal management processes,the authors enhance the conduct of IITs involving off-label drug use.Considering the challenges in legislation and regulation faced during the management of IITs with off-label drug use,the authors provide management recommendations.Emphasis is placed on researchers'ethical awareness,strict supervision,and management of IITs involving off-label drug use,improving internal management processes of medical institutions,ensuring informed consent,and safeguarding the rights of participants.Additionally,researchers are encouraged to engage in substantive collaborations with pharmaceutical companies for IITs involving off-label drug use,sharing risks reasonably.The aim is to provide suggestions for the management of IITs with off-label drug use in medical institutions and optimize the current management status of off-label drug use.
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