The Indian Society for Clinical Research (ISCR) and Quintiles, a fully integrated biopharmaceutical services company, organized an interactive session on Clinical Research. Speakers included Dr Arun Bhatt, executive committee member, ISCR and Suneela Thatte, executive director, customer operations, Quintiles India.
Two leading doctors from Mumbai, Dr C S Pramesh, associate professor and Head of Thoracic Surgery, Tata Memorial Hospital and Dr Vyankatesh Shivane, consultant diabetologist, metabolic physician and joint director, Research Health Institute in Diabetes Endocrinology and Metabolism also participated in the event.
Participants felt that greater awareness and education is necessary among the lay public about what happens during a clinical trial and the need for clinical research in a country like India. India has 17 per cent of the world’s population and 20 per cent of the global disease burden. However, less than two per cent of the global clinical trials are conducted in India. Not only are lifestyle diseases growing in our country but India has diseases that are unique to our part of the world like filaria, leishmaniasis, rabbies, etc. It is therefore important to do research in Indian populations find cures for many of these diseases. The US government’s website pointed out that only 1.7 per cent trials of Global clinical trials are undertaken in India as against 48 per cent in US, 5.2 per cent in UK and 2.3 per cent in China.
Dr Bhatt, ISCR, said, “Drug development is a long, complex and expensive process and it takes on an average around 12-15 years for a new medicine to be developed for human use. Only those medicines that are safe and effective after tests in the laboratory reach the stage of clinical testing. Of 10,000 substances identified as potential drugs, only about 10 make it to the human testing stage and out of these, only one may finally be launched in the market.”
He said that clinical trials are conducted to observe safety and effectiveness of a new drug or device, compare existing treatments to determine which is better, study different ways to use already existing treatments which can be more effective, easier to use, and/or decrease side effects and learn how to best use treatment in a different population, such as patients, in whom the treatment was not previously tested.
There are very strict Guidelines and Regulations in place for the conduct of clinical trials in India said Suneela Thatte of Quintiles while providing an overview of these Guidelines. Both national as well as international Guidelines govern clinical trials in the country she said. There are several stakeholders involved in clinical trials and their roles are also governed by these Guidelines. She said that patient safety, ethics and quality are at the core of any clinical trial and it was extremely important to protect the rights and well being of and maintain the confidentiality of patients in a clinical trial.
Dr C S Pramesh of Tata Memorial Hospital spoke about the role of clinical research in contributing to the advancement of medicine and the benefit of patients. He said that the process of patient selection in a clinical trial involved a high degree of scrutiny and an extensive inclusion and deletion process and that patients cut across all socio economic strata. He highlighted that by 2020, 70 per cent of the global cancer burden would be in developing countries and that there were some cancers like head and neck cancer and cervical cancer that were more prevalent in India and therefore it was imperative for clinical research in these therapeutic areas to be done in India. Significant ethnic and genetic variations in Indian patients make western trial data not completely applicable in India he added.
It is only because of clinical trials that the world has discovered new cancer drugs which have brought down the mortality rate in several types of cancers such as leukemia, lung cancer, bone cancer and breast cancer. He spoke of the stringent processes in place at Tata Memorial Hospital to safeguard patients in a clinical trial. In conclusion he said that improvements in health can only occur with good clinical research and we have to encourage and promote the culture of research in Indian health institutions while training young doctors in clinical research. Clinical research is not just an option, he said and it is mandatory in any health-conscious society.
Dr Vyankatesh Shivane from the Research Health Institute in Diabetes Endocrinology and Metabolism, Mumbai spoke at length about the Informed Consent Process and the challenges and complexities of recruiting a patient in a clinical trial. He said that the informed consent process which involves the investigator, the patient and their family (where appropriate), is conducted in the patient’s local language. This is supplemented with written material pre-approved by the Ethics Committee which the patient can take home. In case of a patient who is illiterate, the contents of the informed consent form are explained orally in the presence of a literate witness, he added. The literate witness then co-signs the patient consent form confirming that the details communicated orally to the patient were in line with what is written in the form. Dr Shivane further clarified that all patients in a clinical trial are free to drop out of the trial at any stage without giving any justification or reason. He also spoke of the role research plays in lifestyle diseases like diabetes to ensure better quality of care and life for patients. As an investigator who has successfully undergone inspections with no findings by national and international regulatory authorities, Dr Shivane shared his experience with these inspections and how rigid and focused on patient safety they are.