| Abstract: | Background
To let Taiwan be?Clinical Research Center of Medicine and Pharmaceutics in Asia?is the goal of the government. However, there are few studies related to the situation of clinical trial environment in Taiwan.
Aim
In order to understand the current status, present study aimed to evaluate and analyze the strength, weakness, opportunity, and threaten (SWOT) of clinical trial environments in Taiwan from the aspects of the factory owners who demand clinical trial service.
Methods
We assessed the environment by the framework of industry environment of Micheal Porter?s diamond model. The questionnaire was validated by the experts, and the results were compared with the published information for reliability.
Main Results
1. Factor conditions: Most users approve the quality of medicine in Taiwan, of people dealing with clinical trials, and of the training program of Department of Health. The cost of clinical trial is higher in Taiwan than Mainland China, but that is lower in Taiwan compared with America.
2. Demand conditions: Factory owners have rapidly increasing demand of diversifying and international preclinical trials. Clinical trials grow at a stable pace, and they are willing to have cooperation with CRO.
3. Supporting and related Industries: In supporting industry, experiment animals of international standard and laboratories of preclinical and clinical trials is of lower value. Clinical trials with air transport service and performed in medical centers is of higher value. The degree of difficulty of case recruitment is the same as before. In related industry, site management organization (SMO) is needed, and so is clinical trial insurance.
4. Government: The associated laws and regulations are inadequate and unpractical. The improvement is needed in the investigated time, transparency, and the communication attitude of Bureau of Pharmaceutical Affairs in Department of Health.
5. SWOT: The clinical trial environment in Taiwan is inferior to other Asia Pacific countries and has more threats than chances.
Conclusions
The government spared no efforts in constructing the environment for clinical trials in Taiwan, and current achievement is brilliant. However, some flaws exist because demands from foreign countries are increasing with the growth of clinical trials and pre-clinical trials. In supporting industries, the quality of experimental animals and the quantity and quality of the laboratory should be improved. In related industries, we should promote internalization of CRO, introduce SMO to the hospitals, and increase the number and enhance the ability of insurance for clinical trials. If necessary, the government should give more helps to the authorities to perfect their efficacy. We suggest the government quicken the pace of internationalization of clinical trial environment in Taiwan, and make progress in previously described aspects to let Taiwan be the model of country with well-designed environment for clinical trials. |
