Investigator training needed to fuel Indian trial growth

By Nick Taylor

- Last updated on GMT

A shortage of investigators with knowledge of trial regulations and ethics is an obstacle to growth of Indian clinical research.

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.

Progress

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​”.

Related news

Show more

Related products

show more

Using Define-XML to build more efficient studies

Using Define-XML to build more efficient studies

Content provided by Formedix | 14-Nov-2023 | White Paper

It is commonly thought that Define-XML is simply a dataset descriptor: a way to document what datasets look like, including the names and labels of datasets...

Overcoming rapid growth challenges with process liquid preparation

Overcoming rapid growth challenges with process liquid preparation

Content provided by Thermo Fisher Scientific - Process Liquid Preparation Services | 01-Nov-2023 | Case Study

A growing contract development manufacturing organization (CDMO) was challenged with the need to quickly expand their process liquid and buffer preparation...

Why should you use clinical trial technology?

Why should you use clinical trial technology?

Content provided by Formedix | 01-Nov-2023 | White Paper

New, innovative clinical trial technology is helping to revolutionize the research landscape. COVID-19 demonstrated that clinical trials can be run much...

Related suppliers

Follow us

Products

View more

Webinars