Mumbai (ISJ) ? A national body of professional clinical researchers claimed, the current stalemate in clinical trials in India would cause ?severe and irreversible damage to clinical research in the country and undermine our ability to bring new drugs to market?. On the occasion of International Clinical Trials Day, the Organisation for Rare Diseases in India (ORDI) said the current stalemate would affect more than 70 million patients with rare diseases, as majority of the over 7000 rare disease prevalent in India do not have an approved drug yet, though many of the rare genetic diseases are treatable.
The Supreme Court of India had asked Union Health Ministry to ensure, drug companies adhere to three mandatory parameters before they conduct human trial of medicines. The drug companies should specify whether the risk involved in testing a new formulation on human being is justified by the benefits expected from the exercise, that there are unmet needs for the drug in the country necessitating the innovation and thirdly, the methods are safer.
Meanwhile, the Indian Society for Clinical Research (ISCR) released a guide for participants of clinical trials. It empowers patients with enough understanding and knowledge on clinical trials so that they can make a responsible and informed decision to participate.
?Ground-breaking scientific advances in the past and the present were and are possible only because of participation of volunteers, both healthy and those diagnosed with an illness, in clinical trials,? said Suneela Thatte, President of the Indian Society for Clinical Research, a body of professional clinical researchers.
The guide says, a potential clinical trial participant is informed by the doctor conducting the trial of all the details of the study prior to his/her participation. This includes treatment details and possible risks and benefits.
International Clinical Trials Day is celebrated on May 20 every year to commemorate Scottish physician Dr. James Lind?s first controlled clinical trial on a group of sailors suffering from scurvy, which resulted in the discovery of Vitamin C, an effective treatment for scurvy.
Source: Indian Society for Clinical Research