In addition, there is an important trend to make available the raw study data, after an appropriate time, in publicly accessible data archives, thus allowing the scientific community opportunity for further analysis and research. 22 Conclusion With the new regulations in place, while the trials may appear very complex to conduct, in a way they are ‘easier’ as the process is now well described with clear guidelines for every step.
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Review of new regulations for the conduct of clinical trials of investigational medicinal products.
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