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What leads Indians to participate in clinical trials? A meta-analysis of qualitative studies.

dc.contributor.author Shah, JY
dc.contributor.author Phadtare, A
dc.contributor.author Rajgor, D
dc.contributor.author Vaghasia, M
dc.contributor.author Pradhan, S
dc.contributor.author Zelko, H
dc.contributor.author Pietrobon, R
dc.coverage.spatial United States
dc.date.accessioned 2011-06-21T17:31:31Z
dc.date.issued 2010-05-20
dc.identifier http://www.ncbi.nlm.nih.gov/pubmed/20505754
dc.identifier.uri https://hdl.handle.net/10161/4541
dc.description.abstract BACKGROUND: With the globalization of clinical trials, large developing nations have substantially increased their participation in multi-site studies. This participation has raised ethical concerns, among them the fear that local customs, habits and culture are not respected while asking potential participants to take part in study. This knowledge gap is particularly noticeable among Indian subjects, since despite the large number of participants, little is known regarding what factors affect their willingness to participate in clinical trials. METHODS: We conducted a meta-analysis of all studies evaluating the factors and barriers, from the perspective of potential Indian participants, contributing to their participation in clinical trials. We searched both international as well as Indian-specific bibliographic databases, including Pubmed, Cochrane, Openjgate, MedInd, Scirus and Medknow, also performing hand searches and communicating with authors to obtain additional references. We enrolled studies dealing exclusively with the participation of Indians in clinical trials. Data extraction was conducted by three researchers, with disagreement being resolved by consensus. RESULTS: Six qualitative studies and one survey were found evaluating the main themes affecting the participation of Indian subjects. Themes included Personal health benefits, Altruism, Trust in physicians, Source of extra income, Detailed knowledge, Methods for motivating participants as factors favoring, while Mistrust on trial organizations, Concerns about efficacy and safety of trials, Psychological reasons, Trial burden, Loss of confidentiality, Dependency issues, Language as the barriers. CONCLUSION: We identified factors that facilitated and barriers that have negative implications on trial participation decisions in Indian subjects. Due consideration and weightage should be assigned to these factors while planning future trials in India.
dc.language eng
dc.language.iso en_US
dc.publisher Public Library of Science (PLoS)
dc.relation.ispartof PLoS One
dc.relation.isversionof 10.1371/journal.pone.0010730
dc.subject Clinical Trials as Topic
dc.subject Humans
dc.subject India
dc.subject Patient Participation
dc.subject Publications
dc.subject Reproducibility of Results
dc.title What leads Indians to participate in clinical trials? A meta-analysis of qualitative studies.
dc.title.alternative
dc.type Journal article
duke.contributor.id Pietrobon, R|0206217
dc.description.version Version of Record
duke.date.pubdate 2010-5-20
duke.description.issue 5
duke.description.volume 5
dc.relation.journal Plos One
pubs.author-url http://www.ncbi.nlm.nih.gov/pubmed/20505754
pubs.begin-page e10730
pubs.issue 5
pubs.organisational-group Duke
pubs.organisational-group Faculty
pubs.publication-status Published online
pubs.volume 5
dc.identifier.eissn 1932-6203


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