Problem Solving by the Entire Community

Mistakes in the design of a drug trial are usually reported as drug failure rather than insufficient expertise, marketing influence, inadequate regulatory management, or improper patient enrolment and follow up. The assumption has been made that these are problems for the pharmaceutical companies to solve. The regulatory role is simply to identify them and reject the failed studies. This might be considered false. It might be considered a problem created by the process of clinical trials, which should be solved by the entire healthcare community [18]. To address this and to reinforce the success of the European Agency, specific changes have been proposed to the European Commission to enlarge the scope of the Agency's activities beyond the evaluation of medicinal products, by strengthening its role as a scientific adviser.

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