How to set up a clinical research center in Brazil, as an example of a middle-income country.
| Autor: | Ribeiro EFO; Hospital Santa Lúcia Sul, Brasília, Brazil. Electronic address: eduardof.o.ribeiro@gmail.com., Belmiro AAMLM; Hospital Santa Lúcia Sul, Brasília, Brazil., Boas LCV; Hospital Santa Lúcia Sul, Brasília, Brazil., Niemann CU; Hospital Santa Lúcia Sul, Brasília, Brazil; Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. |
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| Jazyk: | angličtina |
| Zdroj: | Seminars in hematology [Semin Hematol] 2023 Sep; Vol. 60 (4), pp. 233-242. Date of Electronic Publication: 2023 Sep 04. |
| DOI: | 10.1053/j.seminhematol.2023.08.004 |
| Abstrakt: | In health care, innovation is a core part of the process that pushes advances forward. Drug and device development follow a step-by-step process from the discovery of a molecule to the final product. While patent filing and preclinical studies are usually performed by academic centers or start-ups, the clinical development is usually performed by pharmaceutical companies. To assess safety, efficacy and fulfil regulatory demands, clinical trials must be performed in sequential Phase I, II, and III stages prior to market access. In this context, clinical research centers have been established around the globe, also outside traditional academic centers, aiming to increase the access for patients to participate in clinical trials and the capacity for clinical development. The increasing number of clinical trial sites across the world, gives pharmaceutical companies, investigators and developers an improved access to properly test the exponentially increasing number of potential medicinal products and treatment approaches in trials in different parts of the world. Historically, Low- and Middle-Income Countries (LMIC) did not significantly take part in clinical trial development. As participation in all steps of clinical research provides earlier access to novel treatment options in LMIC along with creating data on efficacy and toxicity within more diverse populations, it is warranted to improve clinical trial access in LMIC. With the goal to provide input on how to tackle the challenges during the built of a clinical research center, we here describe the experience from setting up a clinical trial unit within a private hospital network in Brasília, Brazil, a Middle-Income country, to provide inspiration, "how to" knowledge and a recipe for those with a similar road ahead in LMIC. Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: CUN received research grants and/or consultancy fees from Abbvie, AstraZeneca, Janssen, Genmab, Beigene, Novo Nordisk Foundation, Octapharma, CSL Behring, Lilly and Takeda. EFR received consultancy fees from Abbvie, AstraZeneca, Sanofi, Janssen, Kyte, Astellas and Lilly. Remaining authors declare no conflicts of interest. (Copyright © 2023 Elsevier Inc. All rights reserved.) |
| Databáze: | MEDLINE |
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