Clinical trials prescribing decisions

The provisions of the Directive do not distinguish between commercial and noncommercial clinical trials i.e., those conducted by academic researchers without the participation of the healthcare industry. Furthermore, noninterventional trials where the medicinal product is prescribed in the usual manner in accordance with the terms of the marketing authorization are not within the scope of the Directive. In these cases the assignment of a subject to a particular therapeutic strategy is not decided in advance by a trial protocol, but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the subject in the trial. Also, no additional diagnostic or monitoring procedure is applied to the subjects and epidemiological methods are to be used for the analysis of the collected data. 

In general, the use of Bayesian network meta-analysis has broad applicability to evaluate AEs between related drugs. These methods can provide insight to prescribers and also assess cost-effectiveness. The direct probability statements that result from the Bayesian approach are helpful to decision makers evaluating a variety of medical products for a given therapeutic area/indication. Furthermore, the information obtained from the network meta-analysis can be utilized throughout the medical product development life cycle in simulations to design future clinical trials. 

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