New Delhi: Nobody can deny the fact that a patient sitting on his death bed won’t mind giving it a try. There are numerous patients who have benefited due to clinical trials rather than simply waiting helplessly. One such example is of Asha Singh (name changed) who was suffering from the 3rd stage of terminal disease. Being the sole bread earner, her only concern was to manage the daily chores and earn few rupees. She had no time to think about her health or the treatment. Just then she got to know from the lady she worked for that there is one such hospital where something related to her disease is happening. After check up, when she was told about the actual MRP of the drug which was 1lakh per vial, she was shocked. However, at the same time, when she was explained about the clinical trials and the free cost apart from compensation, she instantly agreed. After three months of trials, he health condition improved though there were few side effects in her body. But she told her doctor it was worth it.
“In this way i had seen many trials where patients are very much taken care. Due to few misunderstandings, whole clinical trial industry has been demonized. It is not like that!,” says the doctor who treated Asha. While Asha is no more but during her last journey, she was happy that she could spend few more years of life with her children.
Green signal to academic trials raise hopes
The Gazette notification on March 16, 2016 by the Ministry of Health and Family Welfare regarding exemption given to academic trials approved by the Ethics Committee for a new indication, new route of administration, new dose or new dosage form of approved drug formulations, is expected to give a much needed boost to institutional research being conducted in India.
“Our academic and teaching institutions are engaged in path-breaking research that addresses the unique health challenges of our country,” said Dr Shashwati Pramanik, Chair, Regulatory Council, ISCR, “The work they are doing is helping create not just new and better treatment for diseases endemic to our region, but is also making them more affordable and accessible to patients. The recent amendment will significantly reduce start-up timelines due to exemption from DCGI approval while maintaining vigilance through Ethics Committees. Thus, this will give a big fillip to these institutions, encouraging more medical practitioners to get involved in clinical research. A focus on patient safety and Good Clinical Practices must continue to be the guiding principles of such research.”
The exemptions will also bring much required spotlight to the academic trials. Perhaps it could also encourage researchers to take up the research activities involving trials.
“If we have to tackle India’s unmet medical needs, we need to make clinical research work for our country. Academic and investigator-initiated research is an imperative not merely an option in India. We are pleased that the Government has provided certain exemptions to academic research which will further encourage academic research in our country,” said Dr C S Pramesh, Professor and Chief, Thoracic Surgery, Department of Surgical Oncology at Tata Memorial Hospital. “Academic research is done to the same stringent local and international guidelines as research done by any sponsor in the country and with equal commitment to patient safety, ethics and quality. We have seen the tremendous benefits that cancer patients at Tata Memorial Hospital have derived from local academic research, both in terms of cost and efficacy and will continue to invest in bringing better and more cost effective treatments to patients.”
