SynthesisBMJ open2015
A critical appraisal of clinical trials conducted and subsequent drug approvals in India and South Africa.
Synthesis in BMJ open, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
8 citing papers in PubMed.
- Three decades of clinical trials in Portuguese-speaking Africa: a comprehensive scoping review protocol.BMJ open · 2026Article
- Patient Benefit of Clinical Research in Diversely Advanced African Developing Countries.Current therapeutic research, clinical and experimental · 2022Article
- Impact of the European Union on access to medicines in low- and middle-income countries: A scoping review.The Lancet regional health. Europe · 2021Article
- Linking market authorizations of medicines with disease burden in South Africa.Journal of pharmaceutical policy and practice · 2021Article
- How Civil Society Organisations Changed the Regulation of Clinical Trials in India.Science as culture · 2019Article
- The role of corruption and unethical behaviour in precluding the placement of industry sponsored clinical trials in sub-Saharan Africa: Stakeholder views.Contemporary clinical trials communications · 2016Article
- It is time to revise the international Good Clinical Practices guidelines: recommendations from non-commercial North-South collaborative trials.BMJ global health · 2016Article
- Which Benefits Are Mentioned Most Often in Drug Development Publications?Current therapeutic research, clinical and experimentalArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo assess the relation between the number of clinical trials conducted and respective new drug approvals in India and South Africa.
designConstruction and analysis of a comprehensive database of completed randomised controlled clinical trials based on clinicaltrials.gov from 1 January 2005 to 31 December 2010 and drug approval data from 2006 until 2013 for India and South Africa.
settingUSA, the EU, India and South Africa.
main outcome measuresPercentage of completed randomised clinical trials for an Investigational Medicinal Product (IMP) leading to new drug approval in India and South Africa.
resultsA total of 622 eligible randomised controlled trials were identified as per search criteria for India and South Africa. Clustering them for the same sponsor and the same Investigational New Drug (IND) resulted in 453 eligible trials, that is, 224 for India and 229 for South Africa. The distribution of the market application approvals between the EU/USA as well as India and South Africa revealed that out of clinical trials with the participation of test centres in India and/or South Africa, 39.6% (India) clinical trials and 60.1% (South Africa) clinical trials led to market authorisation in the EU/USA without a New Drug Application (NDA) approval in India or South Africa.
conclusionsDespite an increase in clinical trial activities, there is a clear gap between the number of trials conducted and market availability of these new drugs in India and South Africa. Drug regulatory authorities, investigators, institutional review boards and patient groups should direct their efforts to ensuring availability of new drugs in the market that have been tested and researched on their population.
Indexed as
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.