One of New Zealand's largest providers of clinical trials has been given a 'gold star' by the US Food and Drug Administration (FDA). The FDA spent 5 days inspecting Middlemore Clinical Trials (MMCT) facility based at Middlemore Hospital looking at participant safety and verifying that submitted clinical trial data was complete and accurate.
The trial was for a new respiratory medication for bronchiectasis that is hoped to be approved for use in the USA this coming year. The lead investigator was senior respiratory consultant, Dr Stuart Jones. “This trial was a great opportunity to involve the Counties Manukau community in the evaluation of this important new medication. Bronchiectasis is a major problem in our community so it’s a trial that is significant for that reason”, he said.
The review of the facilities, people and processes confirmed that MMCT is a quality provider of information that determines whether medicines or devices are safe for use in humans. This inspection by the America-based FDA is a rare event in New Zealand and Australia. That MMCT meets the toughest of benchmarks is deeply satisfying for Clinical and Executive Director, Dr John Baker. "This is a reflection of the highest standards of work done by the MMCT team in collaboration with senior clinicians from Middlemore Hospital," he said.
Middlemore Clinical Trials is currently participating in more than 100 clinical trials of new pharmaceutical drugs and devices. Trials are often multi-centre, involving different cities and countries and are an essential step in attaining approvals for new medications and medical devices. Middlemore Clinical Trials is actively recruiting into clinical trials across many health conditions and is always keen to hear from interested potential participants.
The FDA is known as one of the toughest health watchdogs on the planet, with the stated mission of protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.