In an awareness workshop held here in Hyderabad, the ISCR (Indian Society for Clinical Research), stressed on the need for increasing the number of clinical trials conducted in India. It said only, two per cent of clinical trials are held in India, while 98 per cent clinical research is being conducted in the rest of the world.
The main objective of the workshop was to weed out misconceptions and create more awareness about clinical research among the general public. “Unless there is a proper understanding about the clinical research among the population, it becomes difficult for the CROs to come forward to carry out trials. Today India is burdened by one fifth of global diseases and in this scenario the need for evolution of better medicines and treatment technologies is of utmost importance. Given the conducive environment and ample resources available, India should tap the opportunity of being the best destination for clinical research in the world,” said Dr Arun Bhatt, executive member ISCR.
The clinical research Industry in India is valued at $300 million, while only two per cent of global trials are done in the country. Last year about 200 to 300 trials were held in India against 50,000 trials held elsewhere in the world. The US and European Union are in the forefront in conducting large number of clinical research in the world. US itself constitutes 50 per cent of global clinical trials among 178 countries in the world.
Unless there are enough clinical trials done, it will become difficult to discover new medicines for the ever evolving diseases among the masses. Clinical research plays a vital role in the betterment of treatment of diseases and to invent newer medicines and treatment techniques for future diseases. In fact, a large part of clinical research is directed towards confirming the effectiveness and safety of new medicines and systematically gathering information that will help maximize the benefits while minimizing the risks associated with the use of medicines to treat disease. Applying this information to medical practice helps the doctors to use medicines to their best advantages.
While interacting with Pharmabiz and other media about the media reports on CROs which had flouted the rules with the selection of poor and illiterate as their research subjects, Dr Senthil Jagannathan Rajappa, senior consultant in Medical Oncology, Indo American Cancer Hospital responded, “It may be true that certain companies might have overstepped certain ethical aspects, but CROs just do not select any body who volunteers as subjects of research. There is a lot of scrutiny, inclusion criteria and deletion process that undergoes before the subjects are finally selected. The trials are conducted only after the scientific, ethical and budget committees give their consent. More over the regulations are very much stringent in India. In cases of illiterate patients, they are selected as the subjects of research only after he or she is clearly briefed about the possible consequences affecting the health. After the subject agrees and signs a clear decree of consent only the person is selected as the subject of research. Every subject has his right to withdraw from the research any time without informing the concerned organization. If in case of any untoward incident occurs during the trial to the patient, there will be a financial package to the subject’s family. As clinical trials are experiments to determine the safety and efficacy of a new molecule on human being, there will be some percentage of risk involved. Otherwise how one will be able to know which medicine will work and which will not. Therefore we must encourage more clinical trials and research in our country to help us to discover newer drugs for combating dreadful diseases like cancer and HIV/AIDS.”
The human trials are done only after the drug under development is subjected to intense animal testing. Only if it passes all the safety parameters of animal trials, the drug will be tested in humans that too with utmost care keeping safety of the subject.
“Drug development is a long and complex process which can take even 10 to 15 years. It involves about 100 to 200 millions dollars to bring in a new drug in to the market. Currently for just passing through all the regulations and to get a nod from the authorities to go ahead for a clinical trial approval, it takes at least 16 to 20 weeks,” said Suneela Thatte, executive director, customer operations, Quintiles India.