Speech: P3 Research event

E aku rangatira, tēnā koutou katoa. Ka nui te honore ki te mihi ki a koutou.

Good evening and thank you Richard [Stubbs, Managing Director, P3 Research] for the kind introduction. 

I am delighted to be here tonight to celebrate the completion of renovations to P3 Research’s unit. 

I would like to acknowledge the ground breaking work that P3 Research does, both in Wellington and in Tauranga, to help develop new treatments. 

P3 is actively engaged in a wide range of trials on new medicines for health conditions that particularly impact New Zealanders.

Benefits of clinical trials

The Government fully supports the valuable contribution that clinical trials of medicines, devices and other therapies make to the health of New Zealanders and ultimately globally.

Clinical trials offer a number of benefits to patients, the health system and the economy.  

Clinical trials give patients the opportunity to be involved in developing new treatments.

Even if not everyone volunteering in these studies receives a direct benefit themselves, they contribute to finding treatments to help patients in the future. 

We New Zealanders are altruistic; I have been told that recruitment rates to clinical trials are far higher here than in Australia.

Clinical trials also help NZ to recruit and retain specialists, clinical researchers and academics. 

Encouraging domestic research helps us to develop the next generation of researchers and ensures that there is a focus on researching health issues of particular importance to New Zealanders.

In terms of economic benefits, a study published in 2013 estimated the revenue from pharmaceutical industry sponsored trials as being worth $100 million annually. 

I am excited to hear about the ground breaking Phase II diabetes trial that P3 is working on in conjunction with Australian researchers.

This research builds on observations that patients with type 2 diabetes who have bariatric surgery generally experience a rapid reversal in their diabetes.

Subsequent research has identified that a rise in particular hormone released from the intestine appears to be associated with this reversal and the race is now on to find out whether this hormone could provide a new effective treatment for type 2 diabetes.

The present study being undertaken by P3 Research  involves administration of a synthetic form of the hormone to volunteers with type 2 diabetes to determine if this can achieve a similar remission or improvement in the diabetes to that achieved by bariatric surgery.

Over 200,000 New Zealanders have diabetes, predominantly Type II diabetes; and this disproportionately impacts our Māori and Pacifika communities. 

If this trial is successful, it could pave the way for a totally new and highly effective treatment for Type II diabetes and help turn the tide against New Zealand’s rising rates of diabetes; a condition that places a high burden on the health of our population and sustainability of our health system. 

This trial highlights the need for undertaking clinical trials and the very tangible benefits that they can provide.

Health Committee Review

New Zealand’s robust ethical review processes and regulatory systems, diverse patient populations and high-quality clinicians and researchers make it an attractive place to conduct clinical trials. 

However, the Government is always looking for new ways to improve New Zealand’s ability to attract clinical trials.  

In 2010 and 2011 Parliament’s Health Committee held an inquiry into improving New Zealand’s environment to support innovation through clinical trials. 

The resulting report published in June 2011 made a number of recommendations aimed at simplifying and streamlining the ethical review process and regulation of therapeutic products, while still ensuring patient safety.  

Recommendations included developing standard operating procedures to ensure consistency and transparency of decision making between ethics committees and introducing an electronic submission system for researchers.

The Government introduced expected timelines for approving applications for ethics committees and the Standing Committee on Therapeutic Trials (SCOTT), which approves clinical trials involving new medicines.  

Moving from a paper based system to an electronic system has reduced the time from submission to approval. 

The average approval time for full applications was 25 days less in 2013 than it was prior to changes in 2011.  

The new system places greater trust in researchers and institutions. 

Ethics committees no longer attempt to review the scientific merits of studies, but trust that researchers have ensured the scientific robustness of their studies via appropriate peer review processes. 

Locality authorisations are not given by the ethics committee but are sought by researchers directly from the relevant institution. 

This removes duplication of roles and processes and speeds up the review process.

In a relatively short time, these changes have helped improve New Zealand’s environment for clinical trials, and is one of the reasons NZ selected as one of only two countries for the conduct of the diabetes trial we have been speaking of

From 2011 to 2013 there has been a 20% increase in applications for clinical trials of new medicines. 

The objectives desired by the Inquiry and Government are being reflected in tangible results.

But, all of these changes would mean nothing though if we did not have dedicated researchers like so many of the guests here this evening. 

And to finish I would also like to take the opportunity to acknowledge those New Zealanders who so generously volunteer to participate in clinical trials. 

The volunteers not only show initiative and responsibility for their own healthcare needs, they are also contributing to finding answers for the generation to follow. 

New medicines must be tested somewhere, and with New Zealand’s strong healthcare system and robust regulatory controls, volunteers are well looked after.

I wish you every success in your research here at P3 Research and trust that you will enjoy the rest of the evening.

Thank you.

Nō reira, tēnā koutou, tēnā koutou, tēnā koutou katoa.