The past, present and future of clinical research

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

doi:10.1590/s1807-59322011000600001

Cited by 6 publications

(4 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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“…Clinical research remains cardinal in advancing knowledge of disease, human biology, behavior and informs our health care practice [ 1 ]. In Uganda, there has been an up surge in clinical research driven by both academia and industry.…”

Section: Introductionmentioning

confidence: 99%

A situation analysis of competences of research ethics committee members regarding review of research protocols with complex and emerging study designs in Uganda

et al. 2021

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Background Over the past two decades, Uganda has experienced a significant increase in clinical research driven by both academia and industry. This has been combined with a broader spectrum of research proposals, with respect to methodologies and types of intervention that need evaluation by Research Ethics Committees (RECs) with associated increased requirement for expertise. We assessed the competencies of REC members regarding review of research protocols with complex and emerging research study designs. The aim was to guide development of a training curriculum to improve the quality of scientific and ethical review. Methods This was a cross-sectional study design, with quantitative data collection methods. Research Ethics Committee members completed a structured pre-coded questionnaire on current competence with complex and emerging study design. REC members were asked to outline a list of additional topics for which they needed training. Data from coded questions were entered into Epidata Version 3.1 and then exported to STATA Version14.1 for analysis. Descriptive analysis was performed and findings are presented using percentages and frequencies. Results We enrolled 55 REC members from 6 RECs who have a total of 97 members. The majority of whom were males (56.4%, n = 31/55). The level of competence for review of selected study design was lowest for Controlled Human Infection Model (10.9%, n = 6) and reverse pharmacology design (10.9%, n = 6), and highest for cluster randomized study design (52.7%, n = 29) and implementation science research (52.7%, n = 29). Conclusion Competence for review of research protocols with complex and emerging study design was low among participating REC members. We recommend prioritising training of REC members on complex and emerging study designs to enhance quality of research protocol review.

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The past, present and future of clinical research

Cited by 6 publications

References 7 publications

Overview of pediatric organ transplantation

Overview of pediatric organ transplantation

Clinical research in pediatric organ transplantation

A situation analysis of competences of research ethics committee members regarding review of research protocols with complex and emerging study designs in Uganda

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