2023-04-13T04:52:50
Recommendations of the committee on causality and compensation
After hearing the various stakeholders, namely the pharmaceutical industry, clinicians, civil society and research organizations, and after threadbare discussions among the members of the Committee on the aforesaid issues, recommendations of the Committee are enunciated below.
a) The Committee is of the considered opinion that if any SAE occurs during a clinical trial, it should be the legal duty of the sponsor/investigator to take all steps necessary for providing
medical treatment to the patient in the hospital at their cost, exercising due care and caution till the SAE is resolved. This should be done without getting into the technicalities of
whether the SAE is related or unrelated to the clinical trial. The cost of treatment till resolution of the SAE should be exclusively borne by the sponsor/investigator. It is possible that a SAE or an adverse event (AE) could be caused by a procedure undertaken to deal with an SAE caused by the original drug being evaluated. Compensation needs to be
provided for such SAEs/AEs as well. SAEs/AEs induced by drugs administered to the control group of patients also need to be compensated. The issue of causality may be relevant for payment of compensation in the event of an SAE remaining unresolved, but can have no bearing on the immediate treatment of the participant in the clinical trial for resolution of the SAE.
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