The New Zealand government will work over the next 10 months to streamline and simplify processes for ethics committee reviews of clinical trials.
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 as 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,” he added.
Updating guidelines
The government agreed in its response to the Health Committee report that the “fragmented” procedural guidelines for HDECs needed 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 needed 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 1 July 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 commented.
High-quality destination
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 will also help the country “become acknowledged as a high-quality destination for research investment”, commented Medicines New Zealand general manager Kevin Sheehy.
Approval timelines
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.
In response, the government noted that the law requires Medsafe to make a decision on all such applications within 45 days, acting on the Standing Committee’s advice. In fact, the government added, Medsafe aims to decide on all applications for ‘section 30’ approval within 25 days, “which is substantially shorter than the 45-day timeline in law”.
Act swiftly
The Health Committee report in June urged swift government action to streamline ethical review processes, promote co-ordination 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 commercialisation, if it wanted to compete internationally as a centre for clinical studies.
The inquiry came against a backdrop of declining revenues from clinical trials, increasing competition from countries in the Asia Pacific region that offered favourable conditions for research and in particular the relative boom in Australia’s clinical trial sector.
The government’s response, which can be found in full at www.parliament.nz, took up a number of the recommendations in the Health Committee report, such as:
- improved collaboration between the Ministry of Health, the Ministry of Science and Innovation, the Ministry of Economic Development and New Zealand Trade and Enterprise to co-ordinate and promote clinical trial activity in New Zealand; and
- working with the Ministry of Health, the Health Research Council of New Zealand and the Ministry of Science and Innovation on a national health research strategy, which may include a clinical trial component.
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.
