The past, present and future of clinical research

Azeka, Estela; Fregni, Felipe; Jo, Auler Júnior

doi:10.1590/s1807-59322011000600001

Cited by 7 publications

(5 citation statements)

References 7 publications

(8 reference statements)

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“…Obtaining informed consent either from children themselves or from both parents/legal guardians is a foremost barrier for conducting RCTs in pediatric populations [49,50]. Well designed observational studies involving potential confounding factors might be a solution for overcoming ethical concerns related to RCTs in pediatric population.…”

Section: Randomized Controlled Trialsmentioning

confidence: 99%

Overview of pediatric organ transplantation

Malik

Kassai

Cochat

2015

Current Opinion in Organ Transplantation

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Section: Randomized Controlled Trialsmentioning

confidence: 99%

Overview of pediatric organ transplantation

Malik

Kassai

Cochat

2015

Current Opinion in Organ Transplantation

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“…Randomization of children in the context of a clinical trial poses major ethical concerns, especially when new interventions are being tested. Obtaining informed consent either from the subjects themselves or from parents and legal guardians is a major barrier for randomized clinical trials (RCTs) in pediatric populations ( 18 , 19 ). The Zelen design was implemented as an alternative to conventional RCTs, allowing researchers to seek consent from the patient or parents after randomization is completed.…”

Section: Challenges Inherent To Disease Type and Population Groupmentioning

confidence: 99%

Clinical research in pediatric organ transplantation

Azeka

Saavedra

Fregni

2014

Clinics

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Solid organ transplantation has greatly improved survival in children with end-stage disease, becoming one of the main treatment options in this population. Nonetheless, there are significant challenges associated with validating and optimizing the effects of these interventions in clinical trials. Therefore, we reviewed the main issues related to conducting clinical transplantation research in children. We divided these challenges into three different categories: (i) challenges related to surgical techniques and anesthetic procedures, (ii) challenges related to post-transplant care and (iii) challenges specific to a particular population group and disease type. Some of the observed burdens for clinical research in this field are related to the limitations of conducting studies with a placebo or sham procedure, determining the standard of care for a control group, low prevalence of cases, ethical concerns related to use of a placebo control group and lack of generalizability from animal studies and clinical trials conducted in adult populations. To overcome some of these barriers, it is necessary to utilize alternative clinical trial designs, such as observational studies or non-inferiority trials, and to develop multicenter collaborations to increase the recruitment rate. In conclusion, the lack of robust data related to pediatric transplantation remains problematic, and further clinical trials are needed to develop more efficacious and safer treatments.

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“…Due to their current role, the Research Ethics Committees must include diverse expertise that enables an adequate reviewing process of the research proposals, particularly because the ethical decision issued will determine the permission or not for conducting biomedical and other health related research [4]. This is particularly relevant for the conduct of clinical research, particularly the most frequent design of interventional research -clinical trials [5].…”

Section: Introductionmentioning

confidence: 99%

"Strengthening Biomedical Ethics - Lessons from a Cabo Verde Clinical Trial Case"

Lima Mendoncam

2024

BJSTR

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The uncertainties caused by the COVID-19 pandemic have stimulated biomedical research worldwide to support evidence-based public health policies aimed at reducing the impact of COVID-19 on populations. the resulting urgency of decision-making in a pandemic context faced by Research Ethics Committees created new challenges leading to new reflections on the basic principles of ethics. Starting from a specific case of the implementation of a clinical trial in a pandemic context, this article analyses the emerging ethical and regulatory challenges for the development of clinical trials in Cabo Verde and the path towards strengthening clinical research and biomedical research ethical decision-making in the country. Research in health is important for the social development of a country. It can push forward non-existent but necessary regulatory frameworks in the countries. Legal and ethical gaps related to biomedical research can be overcome to make clinical research possible, as was the case in Cabo Verde and, thus, contribute to the overall development of well-regulated science.

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The past, present and future of clinical research

Cited by 7 publications

References 7 publications

Overview of pediatric organ transplantation

Overview of pediatric organ transplantation

Clinical research in pediatric organ transplantation

"Strengthening Biomedical Ethics - Lessons from a Cabo Verde Clinical Trial Case"

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