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.; Martella, G.; Peppe, A. Leaflet: Operative Steps for interventional studies. Preprints2023, 2023091148. https://doi.org/10.20944/preprints202309.1148.v2
Meringolo, M.; Delle Monache, S.; Martella, G.; Peppe, A. Leaflet: Operative Steps for interventional studies. Preprints 2023, 2023091148. https://doi.org/10.20944/preprints202309.1148.v2
Meringolo, M.; Delle Monache, S.; Martella, G.; Peppe, A. Leaflet: Operative Steps for interventional studies. Preprints2023, 2023091148. https://doi.org/10.20944/preprints202309.1148.v2
APA Style
Meringolo, M., Delle Monache, S., Martella, G., & Peppe, A. (2023). Leaflet: Operative Steps for interventional studies. Preprints. https://doi.org/10.20944/preprints202309.1148.v2
Chicago/Turabian Style
Meringolo, M., Giuseppina Martella and Antonella Peppe. 2023 "Leaflet: Operative Steps for interventional studies" Preprints. https://doi.org/10.20944/preprints202309.1148.v2
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 sub-stance has a range of effects on a given cohort of subjects. The types of trials are different and complex, and often, young clinical novice and the inexperienced researchers may struggle to evaluate how to proceed correctly. In this paper, we aim to create a mini-guide for beginners in clinical trials and provide elements for designing a clinical trial. Our intention is to highlight where to find the materials and how to adapt, even in the absence of sponsors, so that even the most inexperienced and under-resourced researcher can gain an understqanding of the complexi-ty of the process andaddress it appropriately. We do not claim to be exhaustive or cover all ele-ments, but rather, we aim to create a checklist. With this approach, starting discussioms about the experimental phases of the drug and concluding with the clinical trial, we aim to assist those facing this challenging "world."
Keywords
clinical trials; study design, law procedures, statistical approach; health, Patients, Non-Commercial Clinical Trials, enrollment, regulatory agencies, packaging
Subject
Biology and Life Sciences, Life Sciences
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.
