Although India is globally recognized as a major hub for clinical trials, yet its clinical research organizations (CROs) have not been given the responsibility to carry out early clinical research studies. There have been issues on the attitude of investigators and ethics committee on the conduct of unapproved clinical trials.
Despite the international accreditations, several issues need to be addressed. These include improvement in the quality of data generated and adherence to Good Clinical Practices (GCP). Only if these are in place, India will be able to attract an increasing number of clinical trials, stated a panel of experts deliberating on the Issues in Clinical Research & Online Data Management in India. Chaired by D A Prasanna, vice-chairman & MD, Ecron Acunova India, the experts discussed the main problems of the clinical research industry in India
According to Dr Vijay Chauthaiwale, vice-president, Torrent Research Centre, while India is a major hub for global clinical research, most of these studies are part of the global clinical development programme. Therefore Indian CROs lacked the skills of early clinical development especially in translational research and proof of concept studies.
The main hindrance to clinical research in India is the lack of a structured roadmap. Indian CROs need to re-evaluate their business development model and understand that shortcuts do not work. There is a need to seek approvals at every stage and stringent adherences to clinical protocols need to be maintained.
The main reason for this situation to arise is the lack of comprehensive training. Despite the growing number of clinical research institutes in the country, there is no focus on the practical aspects on the conduct of a clinical trial. The current syllabus needs to address the industry needs. Increased industry participation could help to fill up the practical exposure requirements, said Dr Anand Bidarkar, vice-president, SIRO Clinpharm Pvt Ltd.
Dr Anuradha Rajput, general manager, India, ICON Central Laboratories emphasized that there is a need for more number of centralized laboratories rather than local laboratories cater to the data culled on patients' parameters. A Central Lab focuses on centralizing the global collection of lab data. It improves submission quality and reduces timelines. Choosing a right central laboratory along with effective coordination are vital for the successful management of clinical trials. In fact the central lab industry was created out of a need for a more accurate way to collect and report clinical trails data. The facility provided nearly 90 per cent of the data that comprise a new drug application. It also provided study sponsors less than 2 per cent error rate, she said.