BRIEF REPORT | doi:10.20944/preprints202309.1148.v1
Subject: Public Health And Healthcare, Public Health And Health Services Keywords: clinical trials; study design, law procedures, statistical approach; health, Patients, Non-Commercial Clinical Trials, enrollment, regulatory agencies, packaging
Online: 18 September 2023 (09:40:40 CEST)
Clinical trials often involve new substances characterized or developed for a specific pathology or class of pathologies. At other times, a clinical trial is observational; in other words, a known substance has a range of effects on a given cohort of subjects. The types of trials are different and complex, and often, the young clinical novice and the inexperienced researcher cannot correctly evaluate how to follow. In this paper, we want to create a mini guide for beginners in clinical trials and provide elements to design a clinical trial. We intend to point out where to find the materials and how to adjust even in the absence of sponsors so that even the most inexperienced and without means researcher can get an idea of the complexity of the process and deal with it in the right way. We do not presume to be exhaustive, nor claim to value all the elements, but instead realize a checklist. With this spirit, starting to talk about the experimental phases of the drug and ending with the clinical trial, we want to help those who face this problematic "world."