Overcoming the challenges of conducting clinical trials in India

Dr Neena Valecha (on the left) with a colleague.
Dr Neena Valecha, The National Institute of Malaria Research, India

Established in 1977, the National Institute of Malaria Research (NIMR) is India’s premier malaria research institute. Its primary task is to find solutions to the problems of malaria, through basic, applied and operational field research. NIMR has been instrumental in the field evaluation of new tools for malaria control, for example, insecticide-impregnated bed nets and diagnostic kits, many of which have found a place in the Indian national malaria control programme. NIMR also carries out studies on drug resistance, and Phase II/ III trials of new drugs.

1. Where do the challenges for clinical research in antimalarials lie in the context of sponsorship, multi-country trials and capacity building?

In India, conducting clinical trials is a challenge. Malaria is endemic in regions that are inaccessible, have poor health facilities and are typically inhabited by tribal / nomadic populations. Nevertheless, trials must meet stringent regulatory requirements in terms of good clinical practice (GCP) for the results to be internationally accepted. Meeting GCP requirements at these sites is often not feasible, for example, obtaining informed consent is difficult in low-literacy patients. Maintaining uniformity in patient care across the country also presents a challenge.

2. How do you think we can overcome these challenges?

Additional site infrastructure is required – specifically in terms of improved laboratory facilities, (continuous power supply and GCP training) mobility (transport for patient followup) and communication (internet and mobile phones).

3. How could you work with MMV to achieve the goals of malarial elimination and eradication?

NIMR and MMV have had a successful partnership in antimalarial clinical trials and this must continue. The development of safe and effective drugs plays a key role in malaria elimination. MMV should continue to strive towards and support elimination, by speeding the registration and launch of new effective and affordable ACTs. In future, the partnership could even be extended to basic research in the area of drug development.

4. Besides funding, how have you and your team benefited from working with MMV as a partner?

NIMR has benefited directly and indirectly from the partnership. There has been a transfer of technology, and development of manpower (in terms of GCP training) and new clinical trial sites.

Dr Neena Valecha has been a Senior Scientist at NIMR for the last 20 years, conducting a number of drug trials and operational research projects. She is a member of various national and international expert groups on malaria. As a representative for NIMR, she has been the principal investigator of MMV-supported clinical trials for DHA-PQP, Pyramax and RBx 11160.