Alliance aims to boost clinical trials

Cofounded by Taipei Medical University (TMU) and three affiliated hospitals — TMU Hospital, Shuang Ho Hospital and Wanfang Hospital — and Taichung Veterans General Hospital, the alliance aims to turn Taiwan into the Asia-Pacific region’s clinical trial hub, it said.

“Taiwan conducts about 300 to 400 clinical trials a year, which is significantly lower than in South Korea or Australia, which hold more than 1,000 clinical trials per year,” alliance preparation convener TMU president Wu Mai-szu (吳麥斯) said.

Clinical trials must be conducted under strict ethics and regulations to ensure the safety and efficacy of medical innovation, he said.

Whether high-quality clinical trials can be conducted across several facilities is an important indicator of a country’s medical quality and regulatory maturity, he added.

The alliance is to prioritize six major tasks, including setting a standard Institutional Review Board (IRB) document and strengthening the collaborative-IRB mechanism, creating a clinical trial contract template, and building a database of research project managers and attending physicians.

They also include establishing a national clinical trial participant enrollment platform, cooperating in cultivating clinical trial experts, and promoting an Asia-Pacific strategic alliance and international multicenter collaborations, he said.

“This is an important milestone,” Minister of Health and Welfare Shih Chung-liang (石崇良) said at the launch in Taipei.

The development of new drugs has accelerated in the past few years, and more treatments are being developed through molecular approaches and genomic research, which might induce different responses depending on ethnicity or region, making local trials important, he said.

Countries are pursuing local clinical trials to facilitate public access to drugs after they hit the market, he said.

As large pharmaceutical companies prefer to hold clinical trials in locations that have faster patient recruitment rates, the alliance can serve as a single point of contact and apply universal standards and procedures across hospitals, increasing enrollment efficiency and attracting more global pharmaceutical companies to conduct their clinical trials in Taiwan, the minister said.

“The alliance is not only beneficial for international cooperation, it can also help improve Taiwan’s development of new drugs, generic drugs or biosimilars drugs, by increasing the speed of [clinical trial] patient enrollment,” he said. “I think it is a triple-win strategy that would benefit the industry, patients and local academic research.”