Research organizations push back against clinical trials directive

Harmful impact of EU clinical trials directive.

Push Back Design in Two-element Deposits Incorporating Grade Uncertainty (RESEARCH NOTE)

Push back design as a complex task, is one of the major steps in the open pit mines planning. Push backs can be generated by varying economic factors such as commodity price, mining cost, processing cost, etc. Another important issue in generating push backs is grade uncertainty, which can cause the problem be more complex. Conventional methods of push back design ignore grade uncertainty. To o...

The Clinical Trials Directive: How Is It Affecting Europe's Noncommercial Research?

In this article, we examine and discuss the current situation for noncommercial clinical trials in Europe—two years after a new legal framework entered into force. The Clinical Trials Directive, issued in 2001 [1], sought to regulate clinical research in a uniform way across Europe. The basic aims underpinning its development were to cut red tape, speed up research and development, enhance the ...

European Commission considers revisions to clinical trials directive.

T he cancer community is hoping for important revisions to how clinical trials are run in Europe as the European Commission (EC) sets about overhauling the much-criticized Clinical Trials Directive. Adopted in 2001 and implemented by all EU member states in 2004, the directive aimed to create a harmonized framework for clinical research, as well as to improve patient safety and procedures for e...

Evaluation of Clinical Trials

In a number of important clinical issues such as evaluation of the efficacy or effectiveness of therapeutic or preventive interventions as well as for comparing the harms of interventions, randomized controlled trials (RCTs) provide the highest levels of evidence, either directly or indirectly. It is obvious that critical appraisal of these studies to assess their validity and precision is of p...