Background
Navigating the complexities of ethics and regulatory reviews is a critical and often time-consuming step in bringing new medicines to trial. An efficient regulatory strategy is key to initiating clinical research quickly and reliably. In New Zealand, all clinical trials undergo rigorous review before they can begin. New Zealand is recognised as one of the fastest and most reliable jurisdictions in the world to initiate a clinical trial, with approvals often achieved within 4 to 6 weeks.
Ethical approval is overseen by the Health and Disability Ethics Committee (HDEC), while regulatory approval comes from Medsafe, New Zealand’s Medicines and Medical Devices Safety Authority. New Zealand Clinical Research (NZCR) plays an important role in helping sponsors navigate this process.
The Challenge
For those operating in a competitive global landscape, regulatory timelines can be a significant hurdle. Delays in the start-up phase of a clinical trial can impact patient access, budgets, and overall project success. The challenge is to not only meet regulatory requirements but to do so efficiently.
The Approach
NZCR has a highly experienced start-up team dedicated to ensuring smooth project initiation. The team proactively manages submissions, provides protocol consultation when needed, and can prepare documentation directly from draft protocols to avoid delays.
NZCR also provides expert regulatory advice, supporting sponsors throughout the process— from pre-clinical package considerations and CMC requirements to trial design and therapeutic area expertise. NZCR has decades of regulatory experience.
The start-up team’s focus on submitting high-quality HDEC applications from the outset enables a seamless review process. This focus has helped NZCR build a strong reputation with HDEC committee members.
A unique advantage in New Zealand is that HDEC and Medsafe reviews can occur in parallel, allowing faster approvals and contributing to consistently shorter start-up times.
Outcome
The effectiveness of this approach is demonstrated by NZCR’s consistent results. The dedicated start-up team at NZCR ensures submissions are right the first time, achieving very high full approval rates for ethics committee reviews — with more than 95% receiving full approval on the day. This reduces timelines by avoiding additional submissions. On average, the HDEC submission-to-approval timeframe is just 3 to 4 weeks, and the Medsafe submission-to-approval timeframe is around 6 weeks. Since its inception in March 2021, the start-up team has successfully submitted 106 studies.
Key Achievements
- Dedicated Expertise: A specialised start-up team ensures efficient submissions and high-quality outcomes.
- High-Quality Submissions: An initial full approval rate of more than 95% at HDEC meetings reflects the quality of NZCR’s applications.
- Fast Timelines: Average approvals of 3 to 4 weeks for HDEC and 6 weeks for Medsafe ensures rapid study start-up.
- Streamlined Process: Ethics and regulatory reviews can occur in parallel, enabling faster start-up.
- Proven Track Record: With 106 studies submitted since March 2021, NZCR has a proven record of managing regulatory strategies with speed and efficiency.