Indian Government to make biometric ID mandatory for clinical trials

Hit with allegations in the western media about unethical practices in conducting clinical trials, The Indian government and regulatory authorities are making a bolder move planning mandatory biometric identification for clinical trial volunteers in India.

The Ministry of Health and Family Welfare plans to ask all clinical research organisations to enforce biometric identification for the volunteers they recruit for their clinical trials, according to officials at the ministry. Data from the trials will then have to be made available for scrutiny by regulators, civil society groups and the clinical trial industry.

Incidently the government is already started working on a The national Unique Identity Card project (popularly called UID project), mooted on the lines of Social Security Numbers in US.  Heades now by former Infosys CEO Nandan Nilekani who said to have influeced the Book the World is Flat by Friedman. The Indian UID project is project is expected to cost $ 30 Billion USD.

According to the plan, govt proposes to issue a unique identification number to all citizens by 2011. The Unique Identification Authority of India shall own and operate the unique identification number database and also look after its updation and maintenance on an ongoing basis. In the beginning, the UID number will be assigned based on the National Population Register or electoral rolls. Photographs and biometric data will be added to make the identification foolproof

read on the details at http://www.business-standard.com/india/news/govt-may-make-biometric-id-mandatory-for-clinical-trials/378554/

Drug companies conducting their own clinical trials leads to Conflict of Interest a Debate

Ben Goldacre @bengoldacre argues that the financial interests of drug companies lead to distorted evidence, but Vincent Lawton believes that adequate safeguards exist to keep bias in check. Full text of the article is published on BMJ

Dr Goldacre and Prof Lawton faced each other on the same issue recently as opposing speakers at PharmaTimes’s Great Oxford Debate in September, when Dr Goldacre told drugmakers that, by withholding or distorting data, “you shoot yourself in the foot, you undermine your own credibility and mine as a doctor.”

The Pharmatimes review is available at their website http://www.pharmatimes.com/clinicalnews/article.aspx?id=16978&src=EWorldNews

This is interesting , I had written about an actual initiative taken by The Massachusetts Institute of Technology  and 12 Major drug makers to share clinical trial data called NEW Drug Development ParadIGmS or NEWD. details on my earliar post – collaborative clinical trials

World Ecconomic Forum India Economic Summit | Collaborative strategy for drug discovery

The Coverage of the World Ecconomic Forum India Economic Summit is available at  http://blog.livemint.com/wefindia/

I was more interested in the Collaborative Strategy for Drug Development read the interview with Suven Lifesciences a prefered partner to Eli Lilly and Co in Drug Discoverya dn Development in India. http://www.livemint.com/2009/11/10204140/India-Economic-Summit–Collab.html

 

Shorter Path to drug Discovery share research on failed compounds between companies the new MIT lead approach-

The moment I learned about this new project started by MIT, I could think of only one thing, I want to be part of it.  The Massachusetts Institute of Technology, have, started a pharmaceutical innovation program  to help drug companies adapt some successful approaches now used in aeronautics, like lean management and information-sharing among rivals.

The M.I.T. initiative, called NEW Drug Development ParadIGmS or NEWDIGs has garnered the support of

  • Aetna
  • Bayer Healthcare
  • Brookings Institution
  • Centers for Disease Control and Prevention (CDC)
  • Eli Lilly and Company
  • U.S. Food and Drug Administration (FDA)
  • Johnson & Johnson
  • Medco Health Solutions Inc.
  • Pfizer Inc.
  • Quintiles Transnational Corp.
  • Vertex Pharmaceuticals Inc.
  • WellPoint Inc.

One short-term goal is to identify, and rectify, the root causes of bottlenecks in the existing system. Longer term, the ambition is to create new prediction models, new ways to share information about the biology of diseases, and a new inclusiveness involving earlier participation of regulators, health insurers, health care providers and patients.

So How do they plan to change the way we conduct drug discovery and developement?

1.  share information about compounds they have tried and shelved, for reasons like toxicity or inefficacy.

Results of clinical trials are availale online for free, whether or not they succeed. But no pharma company talks about projects that fail at an earlier stage. A result is that companiesother  waste many millions going down experimental paths that their competitors have already tried and failed.

A visual Path of the changes suggested in the Enterprise Transformation is shows here , the document can be downloaded from the MIT website

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