Experts in drugs studies who have participated in a seminar on 'Careers in Clinical Research Industry' organized jointly by the AU-KBC Research Centre of the Anna University and the Apollo Hospitals Education and Research Foundation held the view that volunteers recruited for drug trials must be informed of the merits and demerits out of taking part in the research.
Their involvement in the trials should absolutely be voluntary and the investigators should follow the principles of 'Declaration of Helsinki'. From the beginning to the end of the studies, utmost care is needed to confirm that the ethical values are not infringed.
Dr V T Sriram, medical director of Auroville Healthcare is of opinion that the wellbeing and safety of the trial participants are the prime importance of the studies rather than the results. He said the World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects. Those who engage in drug studies have strictly to follow those ethical principles. The ethical part of the trials is the most important component of the drug research, he said.
Dr Sriram, who takes part in clinical researches said, in India the clinical research is growing fast, but there are some mandatory clauses to be observed strictly. As per GCP, the staff involved in the research must be qualified by education, training and experience which should match international standards. All the researches involving human subjects should be conducted as per the approved rules and regulations and also by ensuring protection and welfare of the participants. The professionals who involve in the study should also be given complete awareness about the current GCP and other ethical practices, he observed.
Dr Vasantha Muthuswamy, former deputy director general of ICMR, New Delhi, said in the past in India clinical trials were carried out mostly for drugs for TB, Leprosy, Malaria and for some vaccines. Today hundreds of trials are going on in India and trials are carried out even for traditional medicines. So many new drugs are being developed and in the last 20 years there are more than 1000 drugs have come into the market. But later studies reveal that many of these drugs are not working. So new solutions to combat this resistance is the need of the hour. For this the hospitals and the industry should collaborate to find new medicines. Government should also ensure that the people of India should be benefited if trials are conducted in the country, she said.
Jayanthi Swaminathan, clinical project manager of Apollo Hospitals, said they are currently conducting 10 to 50 phase 2 and phase 3 trials in the hospital. In the trials Apollo is providing its expertise and following the guidelines, SoPs and principles correctly in order generate quality documents. She said the hospital is planning to open more centres of study with the help of Anna University.
Dr G Ramesh Kumar, academic coordinator of AU-KBC Research Centre and K Srinivasan, Programme Promotion Officer of the Centre has also spoken at the seminar.