Various strategies are in place to monitor safety of trial participants during selleck chemical the conduct of a trial which is not possible once the study related activities cease. The delegation of safety monitoring is also a debatable issue, whether it lies on the investigator or to treating physician. The investigator is reluctant to monitor patients after completion of trial, where the duty of investigator also ends. There are still several lacunae in providing compensation for trial related injuries, and the validity of claims for any investigational drug related injury during post trial access adds to them. The next important aspect to be debated in this regard is the duration for which the post trial access should be offered especially for the patients suffering from chronic diseases.
It is not feasible for the sponsor to offer the investigational drug for unlimited period. It seems to be justified to some extent to provide access till the drug gets approval, but the duration for approval process cannot be pre determined and there should be gradual shift from test medicine to other standard of care. Some sponsors address this issue by extending the study into the continuation phase which is normally open label study and the subjects continue the treatment for a further period of about one to two years or so. But what if drug is not approved? The participants are exposed to ineffective drug for extended duration apart from that required for clinical trial.
The legal implication of continuing the investigational drug beyond the duration of clinical trial should be considered and ethics committees may find it difficult to decide in such circumstances Batimastat for granting approval and monitoring for extended periods. However these issues should be predetermined and addressed in the protocol submitted for regulatory and institutional approvals, a haphazard decision during or after completion of trial to continue access to trial drug to its participants makes the situation complex. Perspectives of major stakeholders regarding post-trial access In the perspective of trial participant, the principle of beneficence as discussed above and non malfeasance where this the loss of benefit derived during trial is equated to doing harm, support the claim for post trial access. Clinically the claim is more valid when no alternative effective treatment exists or when shifting patients to other therapies modify the outcome. The extension of benefit should not lead to undue inducement and participant joining the trial to obtain access to medication.