Globalisation of clinical research has seen India, with its large, heterogeneous patient population, emerge as a leading destination for conducting trials. However, some areas, such as investigator training, have failed to keep up with rapid growth in clinical trials and these must be addressed.
“In India, there is a lack of potential investigators with fundamental knowledge of regulatory, ethical, GCP (good clinical practice) guidelines to conduct clinical trials”, says research in the International Journal of Preclinical and Pharmaceutical Research.
Shortages stem from insufficient formal clinical research training in medical schools and a lack of Government-led efforts. Action by these bodies is needed to support sponsor, contract research organisation (CRO) and site management organisation (SMO) led training programmes.
Building a network of Government-regulated clinical trial centres is proposed to support training.
Ethics and informed consent
Developing a pool of trained investigators will help India overcome some of the other challenges, such as informed consent, highlighted in the research. Oversight of the informed consent process is provided by ethics committees and these must be improved to ensure patients are protected.
“Improper and unethical performance of ethics committees put many poor, illiterate people of India in grave risk”, say the researchers. Areas of concern include ethics committees lacking members with non-clinical backgrounds and failing to have a regular schedule of meetings.
Ethics and informed consent in India are complicated by language. Hindi is the dominant language in India but is only spoken by some of the population. Many local languages and dialects are spoken, particularly in rural areas.
“This makes recruiting a patient population challenging and it becomes necessary to deliver clinical trial materials in multiple Indic languages”, say the researchers. Qualified translators are needed to operate in this fragmented linguistic environment.
Efforts are underway to overcome some of the challenges discussed in the research. Laws and the regulatory system are being strengthened, say the researchers, and there is a focused effort to increase training of clinical trial professionals.
“India is poised to offer the global pharmaceutical industry high quality and cost-effective contract services to support drug discovery, clinical trial conduct, data management and manufacturing”, say the researchers.
Despite current shortcomings India has “a proven track record” in some of these areas and has“an enthusiasm to expand into services at the higher end of the value chain”.