New drugs and other medical products are like one's children. One has to be very careful with their development until they are old enough to be independent and on their own. This usually occurs some time after the product reaches the market and firms up its safety and efficacy profiles.
Consider the pros and cons of a multinational clinical trial before it is agreed to. Three adequately powered uni-national trials are usually preferable to one large multinational trial.
The primary reason why clinical trials fail is because of problems with patient recruitment.
Ask yourself whose responsibility it is to create a strategy that will recruit patients for a sponsored clinical trial. If you said "the investigator" you are wrong. It is the sponsor's responsibility to create a strategy that will be successful, and if there are problems, it is the sponsor's role to learn the cause of the problem and to adjust the strategy to ensure it succeeds.
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