India wants biometric data for trials; may enable Phase I studies
According to a number of media reports the MHFW will ask contract research organisations (CRO) operating in India to take biometric data, including fingerprint and iris data, from all patients who enroll on trial programmes.
An MHFW spokesman told the Business Standard “The move will bring transparency into the conduct of clinical trials. Those who feel Indians are being used as guinea pigs can actually get access to genuine data on the volunteers and their socio-economic backgrounds, and can then arrive at informed decisions.”
India’s trial sector has been rocked by a number of patient consent and safety scandals in recent years, with some even calling for a halt on all trials in the country until standards are improved.
A big part of the problem is that, because trials are carried out at multiple sites over wide areas, it is difficult to monitor records and, for example, identify if a particular patient is taking part in more than one trial at time.
The MHFW says that the collection of patient biometric data into a single centralised resource for scrutiny will help combat this problem and bring Indian trials.
While use of biometrics is likely to increase the price of conducting trials in India, the application of such technology may improve the reputation of the country's research sector and may, in the long run, attract more international pharmaceutical plaers.
Phase I?
The Ministry also suggested the biometrics approach may even enable CROs in the country to begin conducting Phase I trials, which they are currently not allowed to do unless such trials have been carried out elsewhere.
Such an allowance would obviously be welcomed by contract research firms as an extra source of revenue and as a way of keeping up with other emerging trial destinations.
