Clinical research is essential for providing access to new treatments. The regulation of this research is critical, but the degree of regulation is often at odds with the level of risk and complexity of any given trial. This may make the process of gaining approval, and of trial conduct, prohibitively proscriptive and cumbersome, leading to fewer trials being conducted. There is a growing realisation that the regulatory burden should be adjusted in relation to the actual risk and complexity of the trial being proposed. Although the documentation provided here refers to Europe and the US, it is also valid in developing nation contexts where the regulatory burden may be out of proportion to the risk and complexity of a trial, and stifling important clinical research. An example may be where a national medicines regulatory body may require detailed SAE reporting on a trial that uses only licensed drugs already accepted as standard of care.

This link is of interest regarding current trial regulations in the EU: 


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