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

OBJECTIVES: To assess the relation between the number of clinical trials conducted and respective new drug approvals in India and South Africa. DESIGN: Construction and analysis of a comprehensive database of completed randomised controlled clinical trials based on clinicaltrials.gov from 1 January...

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Autores principales: Limaye, Dnyanesh, Langer, Janka Marisa, Rühling, Tjorben, Fortwengel, Gerhard
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4554898/
https://www.ncbi.nlm.nih.gov/pubmed/26324720
http://dx.doi.org/10.1136/bmjopen-2014-007304
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author Limaye, Dnyanesh
Langer, Janka Marisa
Rühling, Tjorben
Fortwengel, Gerhard
author_facet Limaye, Dnyanesh
Langer, Janka Marisa
Rühling, Tjorben
Fortwengel, Gerhard
author_sort Limaye, Dnyanesh
collection PubMed
description OBJECTIVES: To assess the relation between the number of clinical trials conducted and respective new drug approvals in India and South Africa. DESIGN: 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. SETTING: USA, the EU, India and South Africa. MAIN OUTCOME MEASURES: Percentage of completed randomised clinical trials for an Investigational Medicinal Product (IMP) leading to new drug approval in India and South Africa. RESULTS: 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. CONCLUSIONS: Despite 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.
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spelling pubmed-45548982015-09-03 A critical appraisal of clinical trials conducted and subsequent drug approvals in India and South Africa Limaye, Dnyanesh Langer, Janka Marisa Rühling, Tjorben Fortwengel, Gerhard BMJ Open Ethics OBJECTIVES: To assess the relation between the number of clinical trials conducted and respective new drug approvals in India and South Africa. DESIGN: 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. SETTING: USA, the EU, India and South Africa. MAIN OUTCOME MEASURES: Percentage of completed randomised clinical trials for an Investigational Medicinal Product (IMP) leading to new drug approval in India and South Africa. RESULTS: 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. CONCLUSIONS: Despite 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. BMJ Publishing Group 2015-08-31 /pmc/articles/PMC4554898/ /pubmed/26324720 http://dx.doi.org/10.1136/bmjopen-2014-007304 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
spellingShingle Ethics
Limaye, Dnyanesh
Langer, Janka Marisa
Rühling, Tjorben
Fortwengel, Gerhard
A critical appraisal of clinical trials conducted and subsequent drug approvals in India and South Africa
title A critical appraisal of clinical trials conducted and subsequent drug approvals in India and South Africa
title_full A critical appraisal of clinical trials conducted and subsequent drug approvals in India and South Africa
title_fullStr A critical appraisal of clinical trials conducted and subsequent drug approvals in India and South Africa
title_full_unstemmed A critical appraisal of clinical trials conducted and subsequent drug approvals in India and South Africa
title_short A critical appraisal of clinical trials conducted and subsequent drug approvals in India and South Africa
title_sort critical appraisal of clinical trials conducted and subsequent drug approvals in india and south africa
topic Ethics
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4554898/
https://www.ncbi.nlm.nih.gov/pubmed/26324720
http://dx.doi.org/10.1136/bmjopen-2014-007304
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