scholarly journals Access to Medications and Medical Care After Participation in HIV Clinical Trials: A Systematic Review of Trial Protocols and Informed Consent Documents

2009 ◽  
Vol 10 (1) ◽  
pp. 13-24 ◽  
Author(s):  
Andrea L. Ciaranello ◽  
Rochelle P. Walensky ◽  
Paul E. Sax ◽  
Yuchiao Chang ◽  
Kenneth A. Freedberg ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Informed Consent ◽  
Medical Care ◽  
Trial Protocols ◽  
Hiv Clinical Trials

scholarly journals How do community advisory boards fulfil their ethical role in HIV clinical trials? A protocol for a systematic review of qualitative evidence

BMJ Open ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. e035368
Author(s):  
Godwin Pancras ◽  
Maryam Amour ◽  
Tosi Mwakyandile ◽  
Baraka Morris ◽  
Bruno F Sunguya ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Grey Literature ◽  
Cochrane Library ◽  
Global Health Research ◽  
Advisory Boards ◽  
Qualitative Evidence ◽  
Ethical Role ◽  
Hiv Clinical Trials ◽  
Community Advisory Boards

IntroductionCommunity advisory boards (CABs) continue to gain wide use and acceptance in global health research including in HIV clinical trials. They provide means through which community concerns regarding the trial can be considered by the research team, and provide an important platform of communication between the researchers and the community about study goals. Therefore, this systematic review protocol will guide the review of qualitative evidence on the ethical roles of CABs in HIV clinical trials based on the three fundamental ethical principles: respect for the person, beneficence and justice.Methods and analysisThis systematic review of qualitative evidence will involve searching four medical databases: PubMed, ScienceDirect, CINAHL and Cochrane Library. Additionally, other relevant evidence will be obtained through hand searching and grey literature. Searches will be limited to studies published in the English language from 1989 (the year that CABs were first established in HIV clinical trials) to 2019. Articles searched will be screened by two independent authors based on inclusion and exclusion criteria. Included articles will be appraised for quality using the Critical Appraisal Skills Programme checklist and followed by qualitative data extraction. Findings will be analysed based on the meta-aggregative approach with the aid of EPPI-Reviewer 4 web-based software.Ethics and disseminationEthical approval does not apply to this review. Data will be disseminated through scientific conferences and peer-reviewed journals to inform policies and stake-holders about the ethical role of CABs.PROSPERO registration numberCRD42019133787.

Impact of transitioning from HIV clinical trials to routine medical care on clinical outcomes and patient perceptions

AIDS Care ◽  
2011 ◽  
Vol 24 (6) ◽  
pp. 769-777 ◽  
Author(s):  
Baligh R. Yehia ◽  
Judith A. Long ◽  
Cordelia R. Stearns ◽  
Benjamin French ◽  
Pablo Tebas ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Medical Care ◽  
Clinical Outcomes ◽  
Patient Perceptions ◽  
Routine Medical Care ◽  
Hiv Clinical Trials

scholarly journals Participants’ understanding of informed consent in clinical trials over three decades: systematic review and meta-analysis

2015 ◽  
Vol 93 (3) ◽  
pp. 186-198H ◽  
Author(s):  
Nguyen Thanh Tam ◽  
Nguyen Tien Huy ◽  
Le Thi Bich Thoa ◽  
Nguyen Phuoc Long ◽  
Nguyen Thi Huyen Trang ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Informed Consent ◽  
Meta Analysis

scholarly journals Patient reported measures of informed consent for clinical trials: A systematic review

PLoS ONE ◽  
2018 ◽  
Vol 13 (6) ◽  
pp. e0199775 ◽  
Author(s):  
Katie Gillies ◽  
Alexander Duthie ◽  
Seonaidh Cotton ◽  
Marion K. Campbell
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Informed Consent ◽  
Patient Reported ◽  
Patient Reported Measures

scholarly journals A systematic review of subgroup analyses in randomised clinical trials in cardiovascular disease

2021 ◽  
pp. 174077452098486
Author(s):  
Korbinian J Brand ◽  
Alexander Hapfelmeier ◽  
Bernhard Haller
Keyword(s):  
Systematic Review ◽  
Cardiovascular Disease ◽  
Clinical Trials ◽  
England Journal ◽  
New England ◽  
Statistical Significance ◽  
Randomised Clinical Trials ◽  
Primary Analysis ◽  
Subgroup Analyses ◽  
Trial Protocols

Background: Subgroup analyses are frequently used to assess heterogeneity of treatment effects in randomised clinical trials. Inconsistent, improper and incomplete implementation, reporting and interpretation have been identified as ongoing challenges. Further, subgroup analyses were frequently criticised because of unreliable or potentially misleading results. More recently, recommendations and guidelines have been provided to improve the reporting of data in this regard. Methods: This systematic review was based on a literature search within the digital archives of three selected medical journals, The New England Journal of Medicine, The Lancet and Circulation. We reviewed articles of randomised clinical trials in the domain of cardiovascular disease which were published in 2015 and 2016. We screened and evaluated the selected articles for the mode of implementation and reporting of subgroup analyses. Results: We were able to identify a total of 130 eligible publications of randomised clinical trials. In 89/130 (68%) articles, results of at least one subgroup analysis were presented. This was dependent on the considered journal (p < 0.001), the number of included patients (p < 0.001) and the lack of statistical significance of a trial’s primary analysis (p < 0.001). The number of reported subgroup analyses ranged from 1 to 101 (median = 13). We were able to comprehend the specification time of reported subgroup analyses for 71/89 (80%) articles, with 55/89 (62%) articles presenting exclusively pre-specified analyses. This information was not always traceable on the basis of provided trial protocols and often did not include the pre-definition of cut-off values for the categorization of subgroups. The use of interaction tests was reported in 84/89 (94%) articles, with 36/89 (40%) articles reporting heterogeneity of the treatment effect for at least one primary or secondary trial outcome. Subgroup analyses were reported more frequently for larger randomised clinical trials, and if primary analyses did not reach statistical significance. Information about the implementation of subgroup analyses was reported most consistently for articles from The New England Journal of Medicine, since it was also traceable on the basis of provided trial protocols. We were able to comprehend whether subgroup analyses were pre-specified in a majority of the reviewed publications. Even though results of multiple subgroup analyses were reported for most published trials, a corresponding adjustment for multiple testing was rarely considered. Conclusion: Compared to previous reviews in this context, we observed improvements in the reporting of subgroup analyses of cardiovascular randomised clinical trials. Nonetheless, critical shortcomings, such as inconsistent reporting of the implementation and insufficient pre-specification, persist.

scholarly journals Transparent reporting of recruitment and informed consent approaches in clinical trials recruiting children with minor parents in sub-Saharan Africa: a secondary analysis based on a systematic review

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Angela De Pretto-Lazarova ◽  
Domnita Oana Brancati-Badarau ◽  
Christian Burri
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Informed Consent ◽  
Decision Maker ◽  
Secondary Analysis ◽  
Decision Makers ◽  
Sub Saharan Africa ◽  
Study Protocols ◽  
Sub Saharan

Abstract Background Standardised checklists of items to be addressed in clinical study protocols and publications are promoting transparency in research. However, particular specifications for exceptional cases, such as children with minor parents are missing. This study aimed to examine the level of transparency regarding recruitment and informed consent approaches in publications of clinical trials recruiting children with minor parents in sub-Saharan Africa. We thereby focused particularly on the transparency about consenting persons (i.e. proxy decision-makers) and assessed the need to expand reporting guidelines for such exceptional cases. Methods We conducted a secondary analysis of clinical trial publications previously identified through a systematic review. Multiple scientific databases were searched up to March 2019. Clinical trial publications addressing consent and potentially recruiting children with minor parents in sub-Saharan Africa were included. 44 of the in total 4382 screened articles met our inclusion criteria. A descriptive analysis was performed. Results None of the included articles provided full evidence on whether any recruited children had minor parents and how consent was obtained for them. Four proxy decision-maker types were identified (parents; parents or guardians; guardians; or caregivers), with further descriptions provided rarely and mostly in referenced clinical trial registrations or protocols. Also, terminology describing proxy decision-makers was often used inconsistently. Conclusions Reporting the minimum maternal age alongside maternal data provided in baseline demographics can increase transparency on the recruitment of children with minor mothers. The CONSORT checklist should require clinical trial publications to state or reference exceptional informed consent procedures applied for special population groups. A standardized definition of proxy decision-maker types in international clinical trial guidelines would facilitate correct and transparent informed consent for children and children with minor parents. Study registration CRD42018074220.

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