The Central Drugs Standard Control Organisation (CDSCO) has joined hands with the World Health Organisation (WHO) to familiarise Indian clinical researchers with the operational methodologies of Good Clinical Practice (GCP) guidelines. The department has already embarked on a series of technical workshops meant for various stakeholders in clinical trial segment. While six of the workshops organised in various parts of the country were already over, three more are being planned in New Delhi in the coming months.
According to CDSCO, the workshops planned on 25th and 28th of November, are meant for investigators and ethics committee members respectively. The last among the series of programmes is to take place on December 2nd with a focus on sponsor’s role in clinical trials. WHO is supporting the programme under its WHO biennium 2004-’05 programme.
The earlier programmes for ethics committee members, investigators, sponsors and regulators were held at Hyderabad, Kolkotta, Bangalore and Pondicherry. The workshops are coordinated by TN Medical College, Mumbai.
Interestingly, all workshops are based on the training modules prepared by the department of clinical pharmacology, TN Medical College and DYL Nair Hospital, Mumbai. The DCGI had requested these institutions to come out with training modules for different stakeholders involved in the conduct of clinical trials.
Following the success of the pilot workshops organised by these institutions in the month of April 2005, the material developed and validated during these deliberations is now being used for the ongoing workshops.
The workshops were initiated after the need for India to increase its stock of trained manpower was felt, if it has to be a favourite destination for international clinical trials. Since India's large pool of highly trained physicians, nurses and technical personnel and numerous world class medical facilities had less experience in handling clinical trials, the workshops are expected to provide a fillip.
It is expected that training of various stakeholders in clinical trials, namely investigators, ethics committee members, sponsors and regulators, will help in the promotion of the concept of GCP, increase awareness and also help in an increased understanding of the responsibilities of each player, thus leading to an improvement in the quality of the clinical trials being conducted in the country. The need is also emphasised by the recent publication of revised Schedule Y.