In this interview, I had the honor of speaking with Richard Stubbs, who is the President of the New Zealand Association of Clinical Research.
Throughout my career, I've always been fascinated by clinical trials conducted in the Asia-Pacific region. Richard pulls the curtains for us today and shares with us how easy and valuable it is to conduct clinical trials in New Zealand.
Richard is a surgeon by training and also the managing director of P3 Research that is composed of three clinical trial sites in the region.
We tackle a variety of topics including the regulatory framework, start-up process, and even the possibility of moving to beautiful New Zealand to learn and practice clinical trial management.
I hope you enjoy this energetic interview with Richard Stubbs.
[Show Notes]
- A surgeon by training, president of P3 Research, president of New Zealand Association of Clinical Research (NZ-ACR), a national organization
- New Zealand has the first world health system
- Investigator and industry-sponsored research in New Zealand
- Ethics committee approval process
- Organization's mission is the education of clinical research site personnel (research coordinators, nurses, administrators)
- Conference every other year and then more frequent regional meetings
- Access to templates for contracts and indemnity documents, standardized for all sites across New Zealand, similar to MAGI template
- Schedule 6 in the contract allows sponsors to add additional verbiage in the contract
- Political activity encouraging the government to streamline the process for research (ex: New Zealand pavilion at BIO 2019)
- Provisional approved and what it means
- Medical device approval in New Zealand and how it's different from drug approval
- Regulations in New Zealand for Clinical Research
- Reasons why New Zealand is a great location to conduct clinical research, especially for early phase studies
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- Intellectual property protection
- No IND needed
- Fair budget
- Quick data
- Quality data
- Other regulatory bodies trust the data
- New Zealand is part of the Asia Pacific and Japan (APJ) region
- Site Selection in New Zealand
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- How to find sites
- What to consider
- Regulatory approval and site start-up processes in New Zealand
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- Site start-up (gathering essential documents as governed by GCP)
- A centralized and electronic ethics approval process
- Approval of the Ministry of health to allow the importation of the unregistered drug (SCOTT committee that replaces the IND)
- Role of the ethics committee in participant reimbursement
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- Payment to patients generally diminishes with the increase in the phase of the study
- Importance of embedding clinical research in clinical care
- Overhead costs at public and private hospitals in New Zealand
- Only make surplus money out of clinical research is the volume
- Thinking of clinical research in terms of value to patients and their staff
- Moving to New Zealand to start a career in clinical research. There is a need for professionals such as doctors and nurses.
- Value systems in New Zeland such as men and women equality