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ISCR for continuation of clinical trials in India for providing early access to new therapies

Our Bureau, Mumbai
Tuesday, October 8, 2013, 08:00 Hrs  [IST]

The Indian Society for Clinical Research (ISCR) has said that for thousands of patients, participation in a clinical trial can provide early access to new therapies including for debilitating and life-threatening conditions. For patients who have run out of other options, clinical trials are often the last option.
Reacting to the recent Supreme Court order in which the apex court had asked the Centre to create a fool-proof mechanism to save the lives of the people while allowing the clinical trials and stayed the approvals granted to 162 applications for trials, an ISCR spokesperson said that the value and role of clinical research in ensuring better and more effective treatment for several thousands of patients in India is often overlooked.  It is only through clinical research that India has found and will be able to find newer and better medicines to treat the country's population and reduce mortality rates for various diseases, including those unique to this part of the world.
Supporting the court's view that there is need to regulate clinical trials to save the participants, the ISCR spokesperson said, “as a professional organization representing clinical research professionals across the stakeholder spectrum, ISCR is fully supportive of the need for a more robust and regulated environment for the conduct of clinical trials in India which ensures the practice of the highest standards of ethics and quality and where patient rights and safety are protected”.

“We also strongly believe in the need to create a sound clinical research eco system that encourages local research and innovation. There are several biopharma companies, not for profit organizations, and teaching and medical institutions in the country doing a lot of industry-leading and valuable research for diseases that affect our populations. We need to encourage such innovation and not deter the scientific and medical community from continuing in the quest to find safer and more effective treatment for our disease burden”, the ISCR spokesperson added.

As in every profession and industry, there will always be players who operate at both ends of the spectrum. While we do not condone any irregularities, we must acknowledge there are several hundreds of clinical trials taking place in the country in compliance with international and local guidelines. There have been over 40 US FDA clinical trial audits done in India with no critical findings reported. There have also been several European regulatory audits of Indian clinical trial sites, again with no critical findings. Global studies have also shown that there is no difference in quality of data across regions, including India, the ISCR spokesperson further said.


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