The Hindu Business Line : Protecting the patient

BEHIND THE NUMBER is a human volunteer. And this is a reality that stake-holders in the clinical research industry will have to respect when they parade India as the ideal clinical research destination. Indeed, the statistics are impressive. A McKinsey report projects that the Indian clinical research industry could earn $1.5 billion by 2010. The biggest names in the global drug industry are already outsourcing clinical research to India. That its patient-pool is heterogeneous and largely treatment-naïve — with little exposure to medication — makes India an excellent hunting ground for drug companies to undertake human trials. The regulatory environment in India too is in step, enabling more companies to carry out drug trials on human subjects. The Indian Good Clinical Practice (GCP) guidelines and the Indian Council of Medical Research norms for bio-medical research have ensured, to some extent, that patients are not left in the lurch in the event of an adverse drug reaction.

But the process of drug discovery is fraught with uncertainty. The norms mandate that volunteers should not be enticed to participate in a trial with money, and that possible adverse outcomes need to be explained. The compensation to be paid to a patient in the event of a trial gone awry should also be specified, as per the norms. And volunteers are required to sign consent forms, provided in several Indian languages. Hospitals and research organisations doing trials are to have ethics committees to review their projects and ensure that the volunteer is adequately covered. Insurance companies are getting involved in India, as seen with the high-profile clinical trial of the proposed vaccine for AIDS.

And yet, it remains unclear how one provides for an unforeseen risk, disability or death that may occur as a fallout of the clinical trial. Insurance is provided for specifically mentioned adverse events and an eventuality outside that may not get the volunteer his or her rightful compensation. How does one quantify the amount awarded as compensation if there is a disability that may cut short the volunteer's wage-earning capacity? There are instances in developed markets where companies are faced with litigation, not just from the volunteer or his family, but even the next generation. They seek compensation for adverse outcomes of a drug trial, though the data are sometimes released after the volunteer is dead.

In the interest of patients undergoing drug trials, the Government will have to register the ethics committees. This will prevent contract research organisations, for instance, from setting up internal committees to speed up the review of their project. The norms require the ethics committees to have an independent chairperson, and to comprise a mix of non-scientific representatives, social workers, religious leaders, and so on. But with time being of the essence in the bio-equivalence tests, which are mandatory before the medicine comes into the market, these norms get by-passed by some stake-holders. Clinical trials will and should take place in the country to enable easier access to the latest remedies, possibly even formulated for the local population. Only a rigorous implementation of the norms, with self-regulation and a sound conscience in the industry will protect the patient from having to resort to litigation.

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