Clinical trials in low and middle-income countries — Successes and challenges

Grover, Surbhi; Xu, Melody J.; Jhingran, Anuja; Mahantshetty, Umesh; Chuang, Linus; Small, William; Gaffney, David K.

doi:10.1016/j.gore.2016.11.007

Cited by 48 publications

(39 citation statements)

References 52 publications

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“…Although much of the international funding is directed towards human papilloma vaccination and screening research, dedicated funding and new trials will be needed to improve therapeutics in women with cervical cancer. There are several challenges in developing research protocols in LMICs [81], however; the development of international collaborative groups can help to overcome some of these challenges. One such example is the Cervical Cancer Research Network (CCRN), a global networking effort by the Gynaecologic Cancer Intergroup.…”

Section: Collaboration In Researchmentioning

confidence: 99%

Global Collaborations for Cervical Cancer: Can the East–West Alliance Facilitate Treatment for all?

et al. 2019

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Despite the advances in the primary prevention of cervical cancer, there is an absolute increase in the incidence of cervical cancer as a result of an increase in world population. A vast majority of patients in low and lowemiddle income countries continue to present at a locally advanced stage, necessitating treatment with chemoradiation and brachytherapy. There is a dearth of equipment and trained professionals for the treatment of cervical cancer, especially in low and lowemiddle income countries. There is an urgent need to improve treatment availability and develop better treatments. Worldwide trends, however, reveal a low number of therapeutic and innovative research trials in cervical cancer. The present article elucidates the existing challenges and provides solutions to improve outcomes. The proposed strategies hinge on strengthening collaborations for global advocacy.

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Section: Collaboration In Researchmentioning

confidence: 99%

Global Collaborations for Cervical Cancer: Can the East–West Alliance Facilitate Treatment for all?

et al. 2019

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“…One reason for this lack of research is the persistence of many barriers to clinical trial design and execution in LMICs 7. Research studies designed for and carried out in the developed world may not successfully apply in other populations or settings.…”

Section: Introductionmentioning

confidence: 99%

Building research capacity through programme development and research implementation in resource-limited settings - the Ipabalele study protocol: observational cohort studies determining the effect of HIV on the natural history of cervical cancer in Botswana

et al. 2019

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IntroductionThe global burden of cancer continues to increase in low- and middle-income countries, particularly in sub-Saharan Africa (SSA). Botswana, a middle-income country in SSA, has the second highest prevalence of HIV worldwide and has seen an increase in human papillomavirus (HPV)-associated cervical cancer over the last decade in the setting of improved survival of HIV-infected women. There is an urgent need to understand more clearly the causes and consequences of HPV-associated cervical cancer in the setting of HIV infection. We initiated the Ipabalele (‘take care of yourself’ in Setswana) programme to address this need for new knowledge and to initiate long-term research programme capacity building in the region. In this manuscript, we describe the components of the programme, including three main research projects as well as a number of essential cores to support the activities of the programme.Methods and proceduresOur multidisciplinary approach aims to further current understanding of the problem by implementing three complementary studies aimed at identifying its molecular, behavioural and clinical determinants. Three participant cohorts were designed to represent the early, intermediate and late stages of the natural history of cervical cancer.The functional structure of the programme is coordinated through programmatic cores. These allow for integration of each of the studies within the cohorts while providing support for pilot studies led by local junior investigators. Each project of the Ipabalele programme includes a built-in capacity building component, promoting the establishment of long-lasting infrastructure for future research activities.Ethics and disseminationInstitutional review board approvals were granted by the University of Pennsylvania, University of Botswana and Ministry of Health and wellness of Botswana. Results will be disseminated via the participating institutions and with the help of the Community Advisory Committee, the project’s Botswana advisory group.

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“…Even though RCTs are considered to be the gold standard for effectiveness studies [ 32 ], the ability to conduct such trials in LMICs are severely hampered by several logistical challenges [ 32 , 33 ]. For example, in resource-constrained settings, there is a paucity of facilities, trained human resources, and expertise.…”

Section: Introductionmentioning

confidence: 99%

“…For example, in resource-constrained settings, there is a paucity of facilities, trained human resources, and expertise. Thus, the execution of randomized trials is hindered and limited by both high costs and time requirements [ 32 , 33 ]. Furthermore, employing RCTs in complex public health interventions may be inappropriate, misleading, or unnecessarily expensive [ 33 ].…”

Section: Introductionmentioning

confidence: 99%

“…Thus, the execution of randomized trials is hindered and limited by both high costs and time requirements [ 32 , 33 ]. Furthermore, employing RCTs in complex public health interventions may be inappropriate, misleading, or unnecessarily expensive [ 33 ]. This may then partially explain why there are a minimal number of RCTs evaluating DV interventions in LMICs [ 25 , 26 ].…”

Section: Introductionmentioning

confidence: 99%

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Interventions for domestic violence among pregnant women in low- and middle-income countries: a systematic review protocol

et al. 2017

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BackgroundViolence during pregnancy is a global problem, associated with serious health risks for both the mother and baby. Evaluation of interventions targeted for reducing or controlling domestic violence (DV) is still in its infancy, and the majority of findings are primarily from high-income countries (HICs). Therefore, there is an urgent need for generating evidence of DV interventions among pregnant women in low- and middle-income countries (LMICs).MethodsPreferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines will be employed to structure the review. A comprehensive search will be carried out via electronic databases including MEDLINE, CINAHL, Scopus, Embase, Web of Science, PsycINFO, and The Cochrane library. Gray literature will also be scrutinized for potential articles. An optimal search strategy has been developed following consultations with subject-matter experts and librarians. This search strategy will be adapted to the different databases. Experimental studies evaluating DV interventions among pregnant women from LMICs will be included in the review. The review will only include literature written in English. Two reviewers will independently screen and assess studies for inclusion in the review. A third author will resolve any discrepancies between the reviewers. Risk of bias will be assessed based on the Cochrane risk of bias assessment tool, and overall quality of the evidence will be judged using Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) criteria. Findings will be presented with the narrative synthesis, and if applicable, they will be further quantified using random-effects meta-analysis. Effect size, risk ratio for dichotomous variables, and standardized mean differences for continuous variables will be calculated for each outcome using Review Manager 5.3.DiscussionSystematic reviews to evaluate the efficacy of interventions to address DV within the perinatal context have been limited. Hence, no one intervention has emerged as substantially effective towards addressing perinatal DV and associated health consequences. The evidence generated from this systematic review will inform researchers and policy makers about the effectiveness of existing DV interventions among pregnant women in LMICs and provide recommendations for future research in this area. This in turn will contribute towards violence prevention in LMICs.Systematic review registrationPROSPERO CRD42017073938 Electronic supplementary materialThe online version of this article (10.1186/s13643-017-0657-6) contains supplementary material, which is available to authorized users.

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Clinical trials in low and middle-income countries — Successes and challenges

Cited by 48 publications

References 52 publications

Global Collaborations for Cervical Cancer: Can the East–West Alliance Facilitate Treatment for all?

Global Collaborations for Cervical Cancer: Can the East–West Alliance Facilitate Treatment for all?

Building research capacity through programme development and research implementation in resource-limited settings - the Ipabalele study protocol: observational cohort studies determining the effect of HIV on the natural history of cervical cancer in Botswana

Interventions for domestic violence among pregnant women in low- and middle-income countries: a systematic review protocol

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