Pesquisa clínica no Brasil

Rizzo, Luiz Vicente; Camargo, Luís Fernando Aranha

doi:10.1590/s1679-45082013000100001

Cited by 8 publications

(9 citation statements)

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“…After all, the country still experiences endemic dermatological conditions, in addition to lacking independent clinical research for the critical evaluation of the incorporation of new technologies and drugs into the health system. 53 , 54 , 55 …”

Section: Discussionmentioning

confidence: 99%

Bibliometric evaluation of Anais Brasileiros de Dermatologia (2013-2022)

Miot,

Criado,

Castro

et al. 2024

Anais Brasileiros de Dermatologia

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Section: Discussionmentioning

confidence: 99%

Bibliometric evaluation of Anais Brasileiros de Dermatologia (2013-2022)

Miot,

Criado,

Castro

et al. 2024

Anais Brasileiros de Dermatologia

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“…An interesting point is that we expected our sample to cite more openly the advantages related to the benefits of clinical research for patients, but this only occurred in 45% of our sample. In areas such as oncology and inflammatory diseases, patients who participate in studies for new drugs for their illnesses benefit from it, because sometimes there is still no other therapy available; 16 Danesi and Goldbaum 17 point out that "about two billion people in the world are in need of essential drugs", which should be the responsibility of the State, although the pharmaceutical industry shares this responsibility through the development of new drugs which, in its own way, has contributed to advances in the quality of life of patients. 17 However, the main attractions indicated by the researchers in our sample were: updating their knowledge and that of the team involved, additional income for the team, maintaining ties with national and international industry, funding for the center/ institution, ties with international research centers and access to medication and devices not available in Brazil.…”

Section: Discussionmentioning

confidence: 99%

Sponsored multicentric clinical research conducted in Brazil in the respiratory area - losses and gains

Carvalho

Nascimento

Fonseca

et al. 2016

Rev. Assoc. Med. Bras.

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Objective: To evaluate the sponsored centers for clinical trial in the respiratory care setting in Brazil: profile; logistics and structure. Methods: Principal investigators (29) and subinvestigators (30) of 39 research centers completed the questionnaires that addressed personal identification and training of researchers, the centers' facilities and advantages and/or disadvantages of performing sponsored trials. Results: 75.6% of the centers were located in southern and southeastern Brazil. Most principal investigators were men with a mean age of 53.4 years. The clinical trials in the respiratory care setting focus on asthma and chronic obstructive pulmonary disease (COPD). 80% of the researchers cited delay of the Conep and Anvisa as a barrier to performing research. The advantages of participating in clinical trials were updating knowledge of the researcher and the team, and additional income for the team. The main disadvantages mentioned by the researchers included low financial compensation for the performed workload, and time availability. The median number of professionals per research center was six people, predominantly physicians. Conclusion:The number of research centers in the respiratory care setting in Brazil is still relatively small. The teams have good training for performing the clinical trials. Asthma and COPD are the most studied diseases in sponsored clinical trials. The main barrier is delay by the Conep and Anvisa. The factors that lead investigators to participate range from being updated along with the team, to site and staff financial issues; the main disadvantage is the low compensation for the required workload demand.

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“…For example, Brazilian authorities classify clinical research activities as risky drug trials, and the regulation for human research is the same for all types of research—from pharma‐sponsored phase I–III trials to academic studies. Such requirements in oncology trials result in very high costs for simple studies that are almost prohibitive for academic studies; thus, they end up becoming pharma‐sponsored trials .…”

Section: Latin America Clinical Research Environmentmentioning

confidence: 99%

Personalizing Precision Oncology Clinical Trials in Latin America: An Expert Panel on Challenges and Opportunities

et al. 2019

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The participation of patients in precision oncology trials needs to fulfill molecular‐based selection criteria. This strongly limits accrual, and as a consequence, screening successes have decreased, costs have increased, and fewer subjects are enrolled. To achieve narrowed targets, studies have been forced to be multicenter and multinational to reach a larger pool of candidates. However, this globalization faces many challenges, as, for example, in the case of precision oncology trials. These trials have a complex structure that is dependent upon a high‐tech infrastructure and knowledge in a dynamic environment. Given the movement of precision clinical cancer research to regions other than Europe and the U.S., it is important to evaluate the feasibility of performing such trials in lower‐middle‐ and low‐income countries. Here we critically discuss the advantages of conducting precision oncology clinical trials in Latin America and make suggestions on how to overcome the main challenges involved. Implications for Practice Precision clinical trials in oncology are studies that require candidates to have tumors with specific molecular alterations, which are considered the target for the trial experimental therapy. Because many molecular alterations are rare, fewer patients are enrolled. This has led to trials being forced to be multicenter and multinational, including trials in Latin America. This article discusses the challenges and opportunities to conduct precision oncology trials in Latin America, aiming to help sponsors and investigators to solve complex issues that ultimately lead to more of such trials being run in the region, potentially benefiting more Latin American patients with cancer.

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Pesquisa clínica no Brasil

Cited by 8 publications

References 0 publications

Bibliometric evaluation of Anais Brasileiros de Dermatologia (2013-2022)

Bibliometric evaluation of Anais Brasileiros de Dermatologia (2013-2022)

Sponsored multicentric clinical research conducted in Brazil in the respiratory area - losses and gains

Personalizing Precision Oncology Clinical Trials in Latin America: An Expert Panel on Challenges and Opportunities

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