Earlier this month, the US National Institutes of Health (NIH) called off approximately 40 ongoing clinical trials in India.1 So what’s happening and how does it affect us?
Over 2,200 deaths have been reported in the last 5 years of clinical testing in India; as such, the Supreme Court is reacting to better regulate clinical trials in the country. These new rules include updates to their approval process and compensation packages for patients who participate in clinical trials, namely those who become injured or even die during testing.1 Additionally, the health ministry mandates accreditation of all institutional review boards, research institutions, sponsors and contract research organizations (CROs).1
Why the change and what’s this about over 2,200 deaths? Late last year, BBC2 exposed India’s Maharaja Yeshwantrao Hospital to have completed over 70 clinical trials on 3,300 patients, with over half being children. While dozens of people died, no compensation was provided to the affected families. It’s further frightening to discover that these deaths were not reported to the sponsors as many of the patients were recruited without appropriate informed consents (contrary to the Indian laws). Frequently, patients who were from the bottom of the Hindu caste system were asked to sign forms provided only in English, which both patients and children could not understand. Patients were given trial medication under false pretenses (ie, the drugs were funded by special government programs for the poor). BBC2 also reported that at least one recruiting physician was charged for receiving illegal payments and foreign trips from sponsors.
How does this affect us? As a specialist healthcare consultancy firm, we are often supporting clients in global clinical trials where English is not the official language and differences exist in healthcare, based on social and cultural norms. While the BBC report is saddening, I think there are a few things that need to be considered in our line of work when it involves developing countries, language barriers and major differences in medical care such as:
- In providing client counsel, how do we discuss the impact of social and cultural norms in developing countries that will be participating in the trial(s)?
- In developing content and supporting materials for the target population, what needs to be considered?
- How can we support our clients to ensure that communication is not lost in translation between the sponsor, study site staff, third party vendors (including CROs) and patients?
Hopefully the new rules in India will mandate safer and more ethical trials in the country.
1. Krishnan V and Koshy JP, US agency NIH scraps nearly 40 clinical trials in India. Jul 2013. Live mint & the wall street journal. Available at: http://www.livemint.com/Politics/zwG7cCA7nFYFdpzYLXcCVM/US-agency-NIH-cancels-nearly-40-ongoing-clinical-trials-in-I.html
2. Lyod-Roberts S, Have India’s poor become human guinea pigs? Oct 2012. BBC Newsnight. Available at: http://www.bbc.co.uk/news/magazine-20136654