New rules may boost clinical trials

However,the patient will get free treatment for all side effects occurring due to the usage of the potential drug.

The current rules do not make any distinction between a study-related side-effect and a non-related adverse impact that a clinical trial patient may suffer. They also state that if the trial fails to provide the intended result,the patient would have to be compensated.

Once approved,these clarifications in the rules proposed by the Drugs Technical Advisory Board (DTAB) will mean that a hypertension patient who undergoes clinical trial for a new drug will also be treated for any side effect like kidney disorder or depression (which is medicine related).

However,there will be no compensation just because the drug under trial fails to reduce his/her blood pressure or prevent a stroke.

It will also provide some relief to the Indian clinical trials industry,which is worth $500 million in revenue and employs around 15,000 people. Clinical trial expenses account for a major chunk of the drug discovery spend of pharmaceutical MNCs,touted to be anywhere between $1 billion and $3 billion.

The DTAB,the health ministrys apex decision-making body on drugs safety,recently proposed these changes to rule 122 DAB of the Drugs and Cosmetics Act,which deals with grant of compensation related to injury or death during a clinical trial.

Clause C under sub-rule 5 of rule 122 DAB relating to providing financial compensation in case of injury or death due to failure of investigational product to provide intended therapeutic effect may be deleted as there is always a possibility that the investigational product may fail to provide intended therapeutic effect,says DTAB in its recommendations to the health ministry. “medical management should be provided in case the injury is due to clinical trial related activities only,as free medical management may create undue influence for patient to enroll in a clinical trial, the technical committee proposed.

Clinical trials are sets of tests in drug development that prove the therapeutic effect of a particular drug under investigation. In India,clinical trials came under intense scrutiny after pro-health groups took the issue to Supreme Court,seeking greater protection for patients participating in trials after large number of deaths were attributed to such trials.

DTAB also suggested that when a patient is part of the trials placebo group,where he has not been asked to stop his regular medical regime (for any pre-existing diseases),there can be no claim for financial compensation in case of any adverse event. However,the lack of therapeutic effect in placebo trials needs to be explained in detail to the patient before he consents to enter such trial,said DTAB. In a placebo,the patient is not given an actual drug but a dummy drug with no therapeutic effect to compare it against the effects of the actual treatment.

These are encouraging developments. India has a sixth of the worlds population and a fifth of the global disease burden,but less than 1.5% of global trials take place here. This can be changed provided a robust and regulated environment for conduct of clinical trials is created, said Suneela Thatte,president,Indian Society for Clinical Research.

The domestic clinical research organisation market was worth $485 million in 2011 and is set to cross the $1-billion mark by the turn of 2016,according to a Frost & Sullivan report.

The government had put in place a set of rules in January this year to streamline compensation and other processes for governing clinical trials in the country. However,some of the compensation-related clauses had been red-flagged by representatives of the drug industry in letters to the prime minister and health secretary.