The debate on whether India should be allowed to become the ‘clinical trials hub’ of the world is slowly losing fire. When multinational companies zeroed-in on India about a decade back, critics called it their ploy to get “human guinea pigs” in India. Undoubtedly, India’s disease burden in cancer, diabetes and tuberculosis — far more than most countries — was the prime attraction. Add to that the huge population, cheaper operational costs, easy patient procurement, English speaking physicians and IPR preparedness — the perfect setting.
The country’s clinical trials market in 2006 was US$ 140m and is growing at a compounded annual rate of 40%. It is estimated to touch US$ 600m by 2010.
What’s your take on the clinical trials scenario in the country? Do you think India has overcome the initial setback of lack of experienced investigators and clinical research professionals? Is there better awareness of good clinical practice (GCP) compliance? Are ethics always in place?
Quoting from a letter written by me to Lancet in 2006:
(https://www.thelancet.com/journals/lancet/article/PIIS0140673606692398/abstract)
The health-research infrastructure is still weak in India, but investment in more trials will improve it, at least partly, and the benefits will filter down to patients.
Trials will also improve human resource development. Centres participating in these trials, usually the better institutions, have the opportunity to employ more fresh medical graduates than they could usually afford, benefiting both the institutes and graduates. Discussions about trial hypotheses, research methods, and rigour of conduct make clinicians and physicians-in-training more aware of research and ethics. This teaches them the process of evidence generation and assessment—an essential component of evidence-based practice in addition to good clinical practice and discipline.
Participation in international research collaborations also stimulates young clinicians to do more research. Since such activities can be pursued more easily in institutes, I hope that increasing numbers of clinical trials will inculcate a culture of institutional practice among young clinicians, discouraging them from pursuing largely unregulated nursing-home-based private practice. Innumerable patients outside the trials will be the ultimate beneficiaries.
However, we must also focus to strengthen regulatory framework and to promote investigator-initiated research. This can happen as infrastructure and experience improves.
There can’t be a compromise with the health of Indian people in the name of the poor living on the pavements of big cities. Medicines, around 20%, available in the market, are fake and even chemists fail to distinguish them from the original. You can judge then, the impact of such programmes in India in the name of humanity and on the scale of honesty!
Dr. R. Dayal Yadav
The short answer to your questions: NO.
Till such time as medical students are taught (properly) the science of evidence (including its establishment, its analysis, its pitfalls, etc.), we are doomed to remain ‘practical’ clinicians whose papers are largely weak on evidence levels.
I think clinical practice is a very personal skill in a doctor’s professional life. After passing medical examinations, he comes to the society with his respect, greed & hunt of knowledge. Out of these three parameters, the most important for a good clinician is to keep himself away from greed. This is facing a crisis. Earning money is the top priority today.
Very few like me have come to rural areas to research & practice and bring about a change in the medical system of rural India. We survey & gather data to improve life for the rural folks but the atmosphere, local rituals, local systems etc interfere in the application of medical science.
Villages comprise the majority of this country. There should be better rules and systems to serve these areas better.