The New Zealand government will work over the next 10 months to streamline and simplify processes for ethics committee reviews of clinical trials, according to PharmaTimes.
This will create a consistent, more efficient system for health and disability ethics committee (HDEC) assessment of trial applications and will “improve New Zealand’s clinical trials environment without extra investment and in a relatively short time,” the government said.
It was responding to 54 recommendations in a parliamentary Health Select Committee report, published last June, on improving New Zealand’s environment to support innovation through clinical trials.
Launched in February 2010, the Health Committee’s inquiry found that the approval process for clinical studies was “robust but it can take months, sometimes years,” noted Health Minister Tony Ryall. “Applicants need electronic filing, they want much tougher time limits and they need the ethics committees working in a more effective way.”
The government agreed in its response to the Health Committee report that the “fragmented” procedural guidelines for HDECs needs to be updated and streamlined, that application forms should be shortened and simplified, and that electronic applications (online) and a centrally managed system for ethics approvals needs to be developed.
Work on the operating guidelines and application forms will be completed by mid-January 2012, and the electronic filing system will be in place by July 1, 2012, the government said.
Decision-making timelines for ethics committees would be internationally competitive, it promised. “These changes will ensure that ethics committees are more efficient and transparent—and focusing more clearly on protecting participants in higher-risk research,” Ryall said.
The commitment was applauded by Medicines New Zealand, the industry association for innovative pharmaceutical companies, which said the changes would “improve New Zealand's environment for clinical research while preserving the ability to ensure patients’ safety and respect for peoples’ rights.”
They also will help the country “become acknowledged as a high-quality destination for research investment,” said Medicines New Zealand general manager Kevin Sheehy.
The Health Committee had recommended that HDECs should process expedited clinical trial reviews within 30 calendar days and other applications within 45 calendar days. In its response, the government went further, saying updated operating procedures would impose timelines of 35 days for full review and 15 days for expedited review.
As far as scientific reviews of clinical trial applications by Medsafe (the New Zealand Medicines and Medical Devices Safety Authority) are concerned, the Health Committee wanted to see the Health Research Council’s Standing Committee on Therapeutic Trials complete these within 30 calendar days.
The Health Committee report in June urged swift government action to streamline ethical review processes, promote coordination in clinical research, develop a national framework for trials through District Health Boards and formulate a National Health Research action plan to foster innovation and commercialization if it wanted to compete internationally as a center for clinical studies. The inquiry came against a backdrop of declining revenues from clinical trials, increasing competition from countries in Asia Pacific that offered favorable conditions for research and, in particular, the relative boom in Australia’s clinical trial sector.
Medicines New Zealand was disappointed, though, that the government rejected the proposal to create a formal working group with industry to provide further input into implementing the report’s recommendations.