Version 1
: Received: 17 September 2023 / Approved: 18 September 2023 / Online: 18 September 2023 (09:40:40 CEST)
Version 2
: Received: 12 November 2023 / Approved: 13 November 2023 / Online: 13 November 2023 (10:34:23 CET)
How to cite:
Meringolo, M.; Delle Monache, S.; Giuseppina, M.; Peppe, A. Leaflet: Operative Steps for interventional studies. Preprints2023, 2023091148. https://doi.org/10.20944/preprints202309.1148.v1
Meringolo, M.; Delle Monache, S.; Giuseppina, M.; Peppe, A. Leaflet: Operative Steps for interventional studies. Preprints 2023, 2023091148. https://doi.org/10.20944/preprints202309.1148.v1
Meringolo, M.; Delle Monache, S.; Giuseppina, M.; Peppe, A. Leaflet: Operative Steps for interventional studies. Preprints2023, 2023091148. https://doi.org/10.20944/preprints202309.1148.v1
APA Style
Meringolo, M., Delle Monache, S., Giuseppina, M., & Peppe, A. (2023). Leaflet: Operative Steps for interventional studies. Preprints. https://doi.org/10.20944/preprints202309.1148.v1
Chicago/Turabian Style
Meringolo, M., Martella Giuseppina and Antonella Peppe. 2023 "Leaflet: Operative Steps for interventional studies" Preprints. https://doi.org/10.20944/preprints202309.1148.v1
Abstract
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."
Keywords
clinical trials; study design, law procedures, statistical approach; health, Patients, Non-Commercial Clinical Trials, enrollment, regulatory agencies, packaging
Subject
Public Health and Healthcare, Public Health and Health Services
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
