ArticleBMJ global health2016
It is time to revise the international Good Clinical Practices guidelines: recommendations from non-commercial North-South collaborative trials.
Article in BMJ global health, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed.
- Article
- Globalisation of industry-sponsored clinical trials for breast, lung and colon cancer research: trends, threats and opportunities.BMJ oncology · 2023Article
- Stakeholders' views on the most and least helpful aspects of the ICH E6 GCP guideline and their aspirations for the revision of ICH E6(R2).Contemporary clinical trials communications · 2022Article
- Pentoxifylline in the Treatment of Cutaneous Leishmaniasis: A Randomized Clinical Trial in Colombia.Pathogens (Basel, Switzerland) · 2022Article
- Defining clinical trial quality from the perspective of resource-limited settings: A qualitative study based on interviews with investigators, sponsors, and monitors conducting clinical trials in sub-Saharan Africa.PLoS neglected tropical diseases · 2022Article
- Algorithm for the support of non-related (serious) adverse events in an Ebola vaccine trial in the Democratic Republic of the Congo.BMJ global health · 2021Article
- Perspectives on clinical guidelines for severe behavioural problems in children across Europe: a qualitative study with mental health clinicians.European child & adolescent psychiatry · 2020Article
- Collaboration Benefits All.JCO global oncology · 2020Article
- Article
- Application of the rapid ethical assessment approach to enhance the ethical conduct of longitudinal population based female cancer research in an urban setting in Ethiopia.BMC medical ethics · 2018Article
- Good collaborative practice: reforming capacity building governance of international health research partnerships.Globalization and health · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The Good Clinical Practices (GCP) codes of the WHO and the International Conference of Harmonization set international standards for clinical research. But critics argue that they were written without consideration for the challenges faced in low and middle income countries (LMICs). Based on our field experience in LMICs, we developed a non-exhaustive set of recommendations for the improvement of GCP. These cover 3 domains: ethical, legal and operational, and 8 specific issues: the double ethical review of 'externally sponsored' trials; the informed consent procedure in minors and in illiterate people; post-trial access to newly-developed products for the trial communities; the role of communities as key research actors; the definition of sponsor; and the guidance for contractual agreements, laboratory quality management systems, and quality assurance of investigational medicinal products. Issues not covered in our analysis include among others biobanking, standard of care, and study designs. The international GCP codes
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.