Association of Biotechnology Led Enterprises (ABLE) is now looking forward to the Union government for a quick, time-bound and fact-supported mechanism to resolve issues related to clinical trials. The Association has recently approached the Department of Biotechnology (DBT) and Indian Council of Medical Research (ICMR) along with some international companies including Amgen and Roche to come out with a more transparent mechanism to resolve issues in human studies.

“Given the delays in settlement of cases of any untoward event, it is imperative to set up a time-bound and fact-supported mechanism using scientific methods and reasoning to resolve issues in human studies,” Dr PM Murali, president, ABLE told Pharmabiz.

According to ABLE, clinical trials represent an example wherein all stakeholders can and should work together with a broad objective of making the whole clinical research process safe and transparent. Realizing the urgency for the industry to take a pro-active stance to create patient awareness and education about clinical research, ABLE has set up a clinical trials committee.

“The move is to assist the government and the industry to share information arising from drug trials in the public domain in an accessible and proper anonymous manner. We see this initiative significantly easing the concerns as well as ensuring smooth and safe conduct of clinical trials to not only make new drugs available for India  but also meet the aspirations of scientists, researchers and the industry to enable India to remain a credible destination for Clinical Research,” he added.

Patients in other countries actively seek information about the latest medical advances and clinical trials. In the same way, those in India too should be empowered with adequate knowledge on clinical trials reports that are being conducted in specific disease areas to make an informed decision in terms of participation. Hence it is crucial for the industry to actively support such a cause, noted the ABLE president.

Now ABLE’s clinical committee has already submitted an application to the  Supreme Court to plead the petition in the ongoing clinical trial case. The Court hearing fixed for May 6, 2013 has now been postponed to July 2013.

Meanwhile, ABLE has met the concerned government committee and expressed its views over some new issues. “These include  issues covering the basis of compensation which we  feel needs to be rationalized on a scientific basis. Apparently the government is keen to address such logical concerns. In addition, ABLE also arranged a video conference between DBT & ICMR officials in New Delhi connecting several international companies including Amgen and Roche on April 23 during BIOInternational event at Chicago where various matters including clinical trials were discussed in a candid manner. The global industry was quite impressed with the positive and understanding attitude of the Indian government,” he added.