The UK government’s health committee is calling for all clinical trial information to be in the public domain but industry push back is expected, experts say.
The call comes as Sir Michael Rawlins, chairman of the National Institute for Health and Clinical Excellence (NICE), acknowledged that drug companies are not legally obliged to publish all the available data about drugs.
There is “a professional and legal obligation to ensure that all regulators, including NICE, have access to all the available research data,” the health committee said in its report issued Wednesday.
The impact of the report on contract research organizations (CROs) is expected to be minimal. “For the most part, the decisions to release or not release data lie solely with sponsors, not with CROs,” John Lewis of the Association of Clinical Research Organizations, told Outsourcing-pharma.com
But industry sponsors might take issue with these renewed calls for transparency.
“The pushback will depend on what details are reported, to whom and when,” Eldin Rammell of the UK consulting company Rammell Consulting told Outsourcing-pharma.com.
All study data are already reported to the Medicines and Healthcare products Regulatory Agency (MHRA) and ethics committee, Rammell said, adding that if the data are reported too early, they could destroy a company’s market advantage, then hit profits, then “destroy incentive for R&D."
He noted that the requirements and “rationale for reporting to NICE need further clarification.”
However, the UK health committee calls on industry to introduce a new code of practice covering research before the EU’s new clinical trials regulation is approved. The regulation aims to approve trials more frequently and efficiently. The European Medicines agency also published guidance on how the trial data will be made publicly available.
In addition, the UK health committee welcomes the simultaneous current review of trial issues by the House of Commons Science and Technology Committee and recommends that committee should examine both the legal and ethical principles clinical trials and how to make those principles enforceable.
“This is a complex area, so it’s important that any action the Government takes is well thought through, aligns with actions taken at an international level, and doesn’t inadvertently affect the ability to conduct research that will benefit patients,” Heather Walker, policy manager of Cancer Research UK, wrote in a blog post on the report.
The health committee report also focused on health technology appraisals, the new value-based pricing system that NICE is looking to adopt, and the operations of the UK Cancer Drugs Fund.