Progress in Medicine is based on Research. The research and development of a drug requires a long-term investment of 10 to 13 years in duration, while it presupposes the conduction of large and highly costly clinical trials. The overall cost of Research & Development (R&D) has become today even higher because, besides proving the safety and efficacy of each drug, there is also need to prove its added value to the patients' quality of life. The discovery and development of new drugs becomes more and more difficult, since out of the 10.000 molecules that are investigated it is only 1 that will end up as a new drug in the market.
Below follow a brief description of the overall clinical trial process, relevant legislation and the experience of the USUD Clinical Trial Group.