On September 12, experts of the Science and Technology Law Institute (STLI) held under the auspices of the Department of Industrial Technology, Ministry of Economic Affairs (MOEA), a webinar with the collaboration of GeneOnline: “New Horizons in Health Technology Assessment – Global HTA Forward-Looking Strategies”. It was a great event full of insights from the notable speakers, namely Dr. Fei-Yuan Sharon Hsiao, Professor at National Taiwan University’s Graduate Institute of Clinical Pharmacy, Dr. Eunjoo Pacifici, Chair and Associate Professor at the University of Southern California, and others..
The webinar was opened by Dr. Lu Cheng-Yen, Legal Researcher at STLI, who laid out the critical challenges facing countries in the appropriate use of pharmaceuticals, medical devices, and diagnostic tools with small resources for healthcare and related limited budgets. He underlined the systematic assessment made from principles that are scientific, legal, and ethical. Significantly, since the implementation of Taiwan’s National Health Insurance in 1995, much has been accomplished with regard to assessments of health technologies for medical technology reviews that aid policy decisions and provide avenues for rationally allocating resources in a way that quality in health is maintained. Efforts in Taiwan’s HTA have significantly been upgraded with the recent setting up of the Center for Health Policy and Technology Assessment, slated to commence operation by January 2024.
Another important aspect discussed during the webinar is the tremendous growth in clinical trials in the 21st century. While ClinicalTrials.gov has registered more than 100 times as many clinical trials since 2000, investment by biopharmaceutical firms in the research and development of global companies is increasing day by day. In fact, many firms have recently outsourced their trials to CROs.
As much as the number of clinical trials is rising, according to Professor Pacifici, there are still concerns that linger on. The major challenge remains the costiveness of the development process where a new drug takes an average of 10 to 14 years in the clinical trial and will cost up to around $2.6 billion, though up to only 10 percent will pass all stages, and after all this will be given FDA approval for drugs.
These challenges require more contemporary approaches in pharmaceutical research, such as umbrella trials, basket trials, and adaptive designs, among others which are not applicable or consistent with the traditional three-phase trial design. Decentralized or virtual clinical trials have also been established to minimize in-clinic patient visits, speeding up processes mostly in public health emergency contexts. However, Prof. Pacifici points out that these emerging approaches throw up new challenges of maintaining compliance with trial protocols and data integrity.
This webinar is strongly attached to discussion on the evolving landscape of health technology assessment toward optimizing drug development and healthcare delivery.
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