News : Clinical Trials in India Need Better Regulations
Between 2005 and 2012, about 2,800 patients have died while participating in clinical trials conducted by pharmaceutical companies.
Clinical trials are the cornerstone of evidence-based medicine. With a huge population and an easy access to a wide variety of treatment of native diseases, India forms a hotbed for clinical trials for both national and international researchers. India is a signatory to the World Trade Organization (WTO). As a signatory country, it became fully compliant to the Trade Related Intellectual Property Rights (TRIPS) in January 2005. Thus, between 2005 and 2009, clinical trials sprung out like wild weed throughout the length and breadth of the country. There was an overwhelming torrent of Contract Research Organizations (CRO) or the sponsors of such trials.
During this peak of clinical trials in India, it was revealed (in 2009) that 24,000 girls were enrolled in the Human Papilloma Virus (HPV) vaccination trial which, when investigated, was found to have irregularities in informed consent, a key component of all clinical trials. It is believed that between 2005 and 2012, about 2,800 patients have died across the country while participating in all clinical trials conducted by pharmaceutical companies. In fact, there has been a strong scepticism around the conduct and results of clinical trials in countries like India and China.
In a study published in the Journal of Clinical Epidemiology in January 2011, it was concluded that reporting of trials in Indian and Chinese journals falls short in quality when compared to trials published in western journals. Through an active role of the highest court of the country and concerted efforts of health activists, the HPV trial in India was not only halted but a national debate ensued on the conduct of clinical trials in general. It raised some important ethical questions on the feasibility of conducting clinical trials in India. As the government prepares to modify the clinical trial policy of the country, it is essential that the subject be revisited and debated to ensure the efficacy and safety of clinical trials in India, not only from an ethical, but from all points of view. The patient is the single most important component of a clinical trial and all efforts should be made to safeguard the interests of the patient.
Most, if not all, clinical trials happen because of financial interests of the pharmaceutical or implant company/CRO involved in the trial. To clearly understand the pecuniary involvements of the CRO in question, it is crucial that the government should ask for further transparency in such trials. In this respect, Phase 4 clinical trials (post marketing trials) are the most important as a large number of Phase 4 trials are meant to lure doctors into increasing the number of patients using the said drug/implant/treatment. Thus, the conduct of Phase 4 trials need to be specially monitored and regulated by the concerned governmental body.
The revisions in the clinical trials policy should have a more humanitarian perspective besides the regular cliché of scientific advancement as is pushed forth by the researcher and/or CRO. Regulations of financial disclosures need to be strengthened and the onus of such disclosures should be on the CRO or the investigator.
It is shameful that India harbours a significant quantum of major illnesses that are not seen in other parts of the world. In the recent Global Burden of Disease study published in Lancet, India ranked 154th out of 195 countries as far as access to healthcare and quality are concerned. Despite there being a large number of patients with varied conditions in the country, most clinical trials, unfortunately, still focus on ailments that have a western bias to their origin or numbers. The number of trials on indigenous innovative methodologies in the diagnosis, treatment and surveillance of disease typical to the Indian subcontinent are very few. Most of such indigenous trials are either poorly conceived and hence dropped at the evaluation stage or are copies of ongoing trials in some other parts of the world.
(To read the full article Clinical Trials in India Need Better Regulations)
By – Shah Alam Khan is professor of orthopaedics, AIIMS, New Delhi.
Courtesy : thewire.in
It is horrendous to understand and know that we are living in such a country whose leaders, day in and day out, talk about Swach, Vikas, Beti Bachao. But in deeds, they mortgage the citizens to drug and pharma giants to conduct the clinical trials for their new medicines.
They lure rural votes by fake and false propaganda but use those lives as guinea pigs to the disease-producing MNCs rather than inventing medicines for cure.
The continuous and sustained ignorance and refusal of the Govt to provide free and quality medical treatment to the masses leads to such disasters at the hands of corporate interests.
These clinical trials almost seem like a Bio war waged to eradicate not diseases but people !
Even though the linked article talks about regulating clinical trials and ensuring safety of patients, it is impossible to regulate and control the greed of corporates, apathy of governments and helplessness of our people. We should demand a complete stop to clinical trials by private interests.