As India's government churns over the idea of tightening clinical trial regulations, a private industry group is entering the fold and launching a committee designed to improve transparency.
The Association of Biotechnology Led Enterprises is looking to assist the government in its efforts to stamp out unethical trials and make the whole industry less opaque, The Times of India reports, using its transparency committee to share data and results from clinical trials in the public domain.
The data would be anonymized to protect patients' personal information, ABLE says, but the goal is to move much of India's clandestine clinical results into the sunlight, allowing potential trial participants to know the risks and results of therapies before they choose to enroll. And ABLE plans to facilitate the open-source registry by bringing all stakeholders to the table, group President P.M. Murali told the Times.
"To ensure smooth operations, we are keen to support the regulatory body in terms of providing training, as well as provide a more neutral platform for exchange of ideas between the regulator and industry, and also maintain a registry of clinical research organizations, ethics committees, labs and biopharma," Murali said.
Of course, a lack of transparency is just one of the clinical trial-related problems facing Indian regulators. The Central Drugs Standard Control Organization has long struggled to rein in unsafe, unregulated trials, and now the Supreme Court is demanding that it come up with a plan to stem the many deaths and injuries endured by trial participants in the country.
And implementing ABLE's plan can only do so much. Large-scale trial operators like Quintiles will likely have no trouble contributing readable data, but much of the country's woe comes from fly-by-night trial operators who, under Indian law, can easily conduct studies with no minimal clinical safety standard.
- read the Times article