Updated on 24 April 2014
Mr Narayanan Suresh is the Chief Editor of BioSpectrum
In the past decade, clinical trials have become a controversial topic across the world despite the demonstrated effectiveness of the process in making available new drugs to suffering patients for over a century. The secrecy associated with the process, particularly the publication of final results, and controversies over manipulation of data to the advantage of sponsoring companies has been at the heart of the global debate over this issue.
In some key markets such as India, clinical trials is now a bad word with the near emasculation of the sector due to a combination of court judgments and civic society activism.
Can clinical trials regain their glory days as the harbinger of new medication, which is what it actually seeks to achieve? The US-based Biotechnology Industry Organization (BIO) which has almost all the major global biotech players as it members seems to be showing the way out of the clinical trials logjam.
After wide ranging consultation, BIO has released a set of guidelines which mandates all its member companies to share all the key elements of all their clinical trial data to researchers and the public. BIO believes that "responsible clinical trial data sharing advances public health and scientific discourse, honors research participants' expectations of privacy as outlined in their terms of informed consent, and promotes biomedical innovation."