Indian Council of Medical Research (ICMR) is coming out with a dedicated textbook on clinical trials, which is under print. The textbook has been brought out with a World Health Organisation to educate students in pharmaceutical sciences, biotechnology and clinical trial management programmes.
Since the ICMR is a critical participant in the clinical trial programme in the country, it felt that it was mandatory to bring out a textbook covering the key requirements for conducting a trial. "Both education and training are key elements for clinical research sector which is a new employment opportunity for scores of science graduates in the country including doctors, pharmacologists, and biotechnologists. In the wake of this, students keen on making a future out of clinical research need to have a proper and systematic understanding of this sector and hence, ICMR has been instrumental in devising the contents of its textbook which is expected to be a useful guide for students," stated Dr. Rajni Kaul, associate director, ICMR.
Delving into the issue of ethics in the conduct of clinical research, Dr. Kaul stated that companies need to follow ethical principles according to international standards. Therefore need for a continuous training would highlight the shortfalls and issues in conduct of trials. ICMR has dealt with all these aspects in its textbook which is expected to be launched within three months, stated Dr. Kaul. He was speaking at a three-day symposium on 'Best Practises and Current Trends in Clinical Trials and Clinical Data Management,' organised by Vaatsalya Healthcare, Bangalore.
The ethics in clinical trial management covers not only informed consent but privacy and confidentiality of the patients taking on the trial. The textbook has dedicated chapters like Ethical guidelines, Understanding of scientific-ethical issues, bioethics education and legislation to regulate human experiments, Dr. Kaul added.
Equally concerning issues like foreseeable risks of adverse drug reactions, uses of biological samples, compensation for participants, etc. have been matters of concern in conducting clinical trials. ICMR is focusing constantly on international collaborations, capacity building and bio material transfers which are vital to be observed by clinical research organisation and its staff, she stated.
As part of the regular update on Good Clinical Practice (GCP) guidelines, ICMR experts review the existing procedures relating to stricter regulations in ethical issues, patient care resource and plans stricter adherence to regulatory inspections for audit studies.