Maximum number of trials by one investigator may be limited to 3 at a time

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The Health Ministry, as part of further streamlining the clinical sector, may put restrictions on the number of trials that one investigator can take up. However, the authorities would further consult the stakeholders before taking a final decision.

The proposal is being made as the follow-up to the recommendations by the Prof Ranjit Roy Chauhury Expert Committee to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs. The government had already directed that the number of trials an investigator can undertake should be commensurate with the nature of the trial and facility available with the investigator.

The ministry is planning to put the maximum number as three for an investigator to undertake the trials at the same time. Apart from the investigators at the established research organisations which participate at multiple trials, it is alleged that some doctors in hospitals do not mind being involved in any number of trials, thus affecting the very quality of the trials.

Sources said the industry has already opposed the plan and made several representations against the proposal. They have asked the ministry to reconsider the decision to limit the number of trials supervised by an investigator.

According to the industry, the time required to spend on a clinical trial vary from study to study and from stage to stage in a given study. For example, OPD-based study required less time when compared to in-patients studies or study in critically ill patients.  The involvement of an investigator is minimal as per the nature of the study. Putting a number cap abruptly would result in de-growth of current good sites and investigators, as well developed research establishments which cannot participate in multiple studies, even though they have capabilities, staff and infrastructure.

In view of the representations, the ministry has decided to hold more deliberations involving the stakeholders and take an action accordingly. The matter has been discussed already by the technical committee set up by the government. Sources said the apex committee headed by the Health Secretary also went through the proposal, but did not take a final decision.

Source: PharmaBiz


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