Trials Methodology Research: what is it and why should India invest in it?

Summary: This Viewpoint presents an overview of trials methodology research (TMR) and the case for investing in TMR in India. Randomised controlled trials and other types of clinical research inform evidence-based medicine, but this endeavour is dependent on the quality of such research. TMR is aime...

Full description

Bibliographic Details
Main Authors: Sangeetha Paramasivan, Anant Bhan, Rashmi Rodrigues, Usha Menon
Format: Article
Language:English
Published: Elsevier 2024-03-01
Series:The Lancet Regional Health - Southeast Asia
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S2772368224000106
_version_ 1797265576195784704
author Sangeetha Paramasivan
Anant Bhan
Rashmi Rodrigues
Usha Menon
author_facet Sangeetha Paramasivan
Anant Bhan
Rashmi Rodrigues
Usha Menon
author_sort Sangeetha Paramasivan
collection DOAJ
description Summary: This Viewpoint presents an overview of trials methodology research (TMR) and the case for investing in TMR in India. Randomised controlled trials and other types of clinical research inform evidence-based medicine, but this endeavour is dependent on the quality of such research. TMR is aimed at improving the way in which clinical trials are designed, conducted, analysed, and reported. The evolution of TMR in countries like the UK has been nurtured through dedicated funding support. Similar funding opportunities for TMR in India will help optimise the ethical and methodological rigour of the growing number of trials conducted in India. Such funding could help initiate an interdisciplinary network of key stakeholders in India to lead on TMR priority-setting exercises so that methodological questions of relevance to India are addressed. The establishment of trials methodology hubs will enhance initiatives such as the disease-specific clinical trials networks being set up as part of the National Biopharma Mission in India. We posit that promoting and establishing TMR as a distinct field of study in India will ensure the improvement of our health research ecosystem and call on national and international funding bodies to initiate consultation, consensus building and ringfenced funding for TMR in India.
first_indexed 2024-04-25T00:46:59Z
format Article
id doaj.art-fca3d44ab66f46ccaa64605731eb83f7
institution Directory Open Access Journal
issn 2772-3682
language English
last_indexed 2024-04-25T00:46:59Z
publishDate 2024-03-01
publisher Elsevier
record_format Article
series The Lancet Regional Health - Southeast Asia
spelling doaj.art-fca3d44ab66f46ccaa64605731eb83f72024-03-12T04:17:01ZengElsevierThe Lancet Regional Health - Southeast Asia2772-36822024-03-0122100360Trials Methodology Research: what is it and why should India invest in it?Sangeetha Paramasivan0Anant Bhan1Rashmi Rodrigues2Usha Menon3Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom; Corresponding author.Bhopal Hub, Sangath, India; Centre for Ethics, Yenepoya (Deemed to be University), Mangaluru, Karnataka, IndiaCommunity Health, St. John's Medical College, St. John's National Academy of Health Sciences, Bengaluru, Karnataka, IndiaMRC Clinical Trials Unit, University College London, Institute of Clinical Trials and Methodology, London, United KingdomSummary: This Viewpoint presents an overview of trials methodology research (TMR) and the case for investing in TMR in India. Randomised controlled trials and other types of clinical research inform evidence-based medicine, but this endeavour is dependent on the quality of such research. TMR is aimed at improving the way in which clinical trials are designed, conducted, analysed, and reported. The evolution of TMR in countries like the UK has been nurtured through dedicated funding support. Similar funding opportunities for TMR in India will help optimise the ethical and methodological rigour of the growing number of trials conducted in India. Such funding could help initiate an interdisciplinary network of key stakeholders in India to lead on TMR priority-setting exercises so that methodological questions of relevance to India are addressed. The establishment of trials methodology hubs will enhance initiatives such as the disease-specific clinical trials networks being set up as part of the National Biopharma Mission in India. We posit that promoting and establishing TMR as a distinct field of study in India will ensure the improvement of our health research ecosystem and call on national and international funding bodies to initiate consultation, consensus building and ringfenced funding for TMR in India.http://www.sciencedirect.com/science/article/pii/S2772368224000106Clinical trialsTrials methodology researchRandomised controlled trialsIndia
spellingShingle Sangeetha Paramasivan
Anant Bhan
Rashmi Rodrigues
Usha Menon
Trials Methodology Research: what is it and why should India invest in it?
The Lancet Regional Health - Southeast Asia
Clinical trials
Trials methodology research
Randomised controlled trials
India
title Trials Methodology Research: what is it and why should India invest in it?
title_full Trials Methodology Research: what is it and why should India invest in it?
title_fullStr Trials Methodology Research: what is it and why should India invest in it?
title_full_unstemmed Trials Methodology Research: what is it and why should India invest in it?
title_short Trials Methodology Research: what is it and why should India invest in it?
title_sort trials methodology research what is it and why should india invest in it
topic Clinical trials
Trials methodology research
Randomised controlled trials
India
url http://www.sciencedirect.com/science/article/pii/S2772368224000106
work_keys_str_mv AT sangeethaparamasivan trialsmethodologyresearchwhatisitandwhyshouldindiainvestinit
AT anantbhan trialsmethodologyresearchwhatisitandwhyshouldindiainvestinit
AT rashmirodrigues trialsmethodologyresearchwhatisitandwhyshouldindiainvestinit
AT ushamenon trialsmethodologyresearchwhatisitandwhyshouldindiainvestinit