A critical appraisal of clinical trials conducted and subsequent drug approvals in India and South Africa

BMJ Open
Dnyanesh LimayeGerhard Fortwengel

Abstract

To assess the relation between the number of clinical trials conducted and respective new drug approvals in India and South Africa. Construction 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. USA, the EU, India and South Africa. Percentage of completed randomised clinical trials for an Investigational Medicinal Product (IMP) leading to new drug approval in India and South Africa. A 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....Continue Reading

References

Aug 14, 2001·Theoretical Medicine and Bioethics·S R Benatar
Apr 20, 2005·Journal international de bioéthique = International journal of bioethics·UNKNOWN World Medical Association General Assembly
Jul 3, 2007·Journal of Medical Ethics·Colleen C Denny, Christine Grady
Feb 21, 2009·The New England Journal of Medicine·Seth W GlickmanKevin A Schulman
Feb 5, 2010·Clinical Pharmacology and Therapeutics·J A DiMasiA Wilson
Oct 26, 2011·Journal of Pharmacology & Pharmacotherapeutics·Preeti YadavN D Kantharia
Jun 22, 2012·PLoS Medicine·Trudie Lang, Sisira Siribaddana

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Citations

Jan 11, 2019·Clinical Trials : Journal of the Society for Clinical Trials·Colene BentleyStuart Peacock
Aug 9, 2019·Science As Culture·Salla SariolaGerard Porter
Apr 3, 2021·Journal of Pharmaceutical Policy and Practice·K NarsaiA K Mantel-Teeuwisse
Oct 26, 2021·The Lancet Regional Health. Europe·Katrina PerehudoffAnniek de Ruijter

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