Scientific research methods

The positivist scientific paradigm currently in use dates back to the Galilean method: the researcher proceeds from the collection of data from observation and experimentation, on these bases he or she develops hypotheses and theories. In a nutshell, it can be said that this interpretation of reality is based on models susceptible to improvement and modification as new facts and events occur.

At the moment, the implementation of a scientific study must respect the norms of Good Clinical Practice GCP, an international standard of scientific ethics and quality that regulates the design, conduct, reporting and publication of clinical trials involving human subjects. These standards not only do publicly guarantee the protection of rights, safety and wellbeing of the subjects participating in the study, in accordance with the principles established by the Helsinki Declaration, but also the reliability of the data related to the study. The GCP was developed by the International Council for Harmonisation (IHC) in 1996, adopted by the European Union in 1996 and implemented for clinical trials from 17 January 1997 also in the UK. Nevertheless, the GCP guidelines were not enforced by law at that time in the UK but in 2004 with The Medicines for Human Use (Clinical Trial) Regulation…

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