Clinical trials: Expert panel's views differ from formula under study

Confusion over clinical trial compensation norms

Even as the health ministry is evaluating a formula to compensate victims of clinical trials, an expert committee, headed by Ranjit Roy Chaudhury, has recommended some stringent measures that appear contrary to the formula under consideration.

The committee, set up by the ministry to formulate policy and guidelines for clinical trials, has suggested that no compensation be given for therapeutic inefficiency during clinical trials or if it is proved the cause of death or injury is unrelated. Besides, the panel has recommended compensation not be given to terminally-ill patients, such as those suffering from cancer, if the primary end-point is death, according to the clinical trial protocol.

This is in clear variance with the formula being considered by the ministry which suggests a fixed compensation of Rs 2 lakh for patients whose expected mortality is 90 per cent or more within 30 days. This is the minimum compensation being considered under the formula.

The recommendations of the panel, headed by Roy Chaudhury, the national professor of pharmacology and advisor in the Delhi government’s department of health and family welfare, work in the industry’s favour. But health activists say it will not only hurt victims but also discourage many terminally-ill patients from enrolling for trials, as they would not see any benefit coming out of it.

“Terminally-ill patients usually enrol for trials related to very complicated diseases, mainly cancer. In such cases, many untested drugs are often given,” said a health activist with the Swasthya Adhikar Manch. The activist added: “If they are not given compensation, their family members may not like to enrol them.”

However, the industry feels it is important for the government to recognise the nature of death while determining the compensation.

“The statistics of death are so vague, one cannot pinpoint whether it is due to clinical trials or illness. For example, if one is testing a cancer drug, cancer drugs, except in few cases, are used to just prolong the life by a few years or months. So, one considers those deaths as being due to clinical trials,” said Shivprakash Rathnam, managing director of Ahmedabad-based Synchron Research Services, one of first clinical research organisations (CROs).

According to the formula under the health ministry’s consideration, compensation in other routine trial cases might vary from a minimum of Rs 4 lakh to a maximum of Rs 73,60,000, depending on the age of the deceased and the risk factor. However, in the case of patients whose expected mortality is 90 per cent or more within 30 days, a fixed amount of Rs 2 lakh could be given.

The Roy Chaudhury committee has also recommended a single-window clearance for clinical trials. “The 12 drug advisory committees functioning at present will be replaced by one board-expertise-based technical review committee to ensure speedy clearance of applications without compromising on quality of data and rules and regulations,” the committee said in its report, given to the Drugs Controller General of India (DCGI). The panel was set up in February this year and was also mandated to formulate rules for approval of new drugs and banning of drugs in the country, apart from looking into clinical trials.

Another significant recommendation made by it includes creation of a fund by levying cess to be be used for compensation of clinical-trial victims. “The Government of India, state governments and institutions should create a fund to encourage academic and clinical research (non-pharmaceutical company-related) in institutions. The fund may be raised by imposing a cess, if needed. This fund will be available to the institution for paying compensation,” the report said.

LATERAL SHIFT
Key suggestions of the Ranjit Roy Chaudhary panel

* A central council be set up to oversee accreditation of institutes, clinical investigators and ethics committees

* The 12 drug advisory panels functioning at present be replaced by an expertise-based technical review committee

* Audio-visual recording of the informed consent process be undertaken and the documentation preserved

* Compensation need not be paid for injury or death due to totally-proven unrelated causes

* No compensation for therapeutic inefficiency, since the purpose of clinical trials is to determine efficacy and safety of drugs

* Creation of fund to encourage academic and clinical research; could be raised by imposing a cess and made available to institutions for paying compensation

* IT be used at all steps of a clinical trial to ensure total transparency in the system