The ground reality of reaching the health provider very fast needs careful consideration before approving a placebo controlled trial. Post selleck Vorinostat trial access to IP The DOH lays much emphasis on post-trial access to trial drugs stating. “The protocol should describe arrangements for post-study access by study subjects to interventions identified as beneficial in the study or access to other appropriate care or benefits.” The ICMR guidelines make a vague recommendation that post trial access should be provided whenever possible, and states that in student’s projects this may not be possible. It is doubtful if many of the 596 IRBs registered in the country have paid attention to this clause. Supplying the IP in the post-trial period is fraught with difficulties.
Firstly, the IP would be used outside the trial, without the safeguards the trial provides. In case a serious adverse event (SAE) occurs, the subject would have to consult the original principal investigator (PI), since another physician may not have the knowledge about the IP to handle the SAE. Also sponsors do not make additional IP available to the PI, hence the IRB must look into this more carefully. Use of LAR/witness Though there has been a lot of debate on who may be considered the LAR, a precise definition of LAR is lacking. The GCP requires that ??the investigator must obtain informed consent from the legally authorized representative in accordance with applicable law??. In a country where there is a multiplicity of laws, one does not know which law is the applicable one. Indian regulators need to clarify this in a guidance document.
The Indian Good Clinical Practice (GCP) speaks of the use of impartial witness while taking consents of vulnerable subjects (CDSCO GCP 126.96.36.199.2). The impartial witness is defined as: ??An impartial independent witness who will not be influenced in any way by those who are involved in the Clinical Trial, who assists at the informed consent process and documents the freely given oral consent by signing and dating the written confirmation of this consent??. Impartial here means that a person who will not take either the investigator’s side or the subject’s side; neutral person. However, the Belmont report states that ??the third parties Drug_discovery chosen should be those who are most likely to understand the incompetent subject’s situation and to act in that person’s best interest??, calling for judgment of the investigator rather than the relation of the potential LAR to the subject.
A clarification on this issue is urgently needed. Conflict of interest Commercial IRBs raise the possibility of financial conflict of interest; such IRBs abound in the US. India is largely spared of this problem. Yet moreover conflict of interest among IRB members remains to be checked. In the US, as many as 36% of IRB members were found to have had some relation with the pharmaceutical industry, the figure for India is not known.