title: What leads Indians to participate in clinical trials? A meta-analysis of qualitative studies.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Graduate Medical School, Duke-National University of Singapore, Singapore, Singapore.
authors.forename: Jatin Y
authors.initials: JY
authors.lastname: Shah
authors.forename: Amruta
authors.initials: A
authors.lastname: Phadtare
authors.forename: Dimple
authors.initials: D
authors.lastname: Rajgor
authors.forename: Meenakshi
authors.initials: M
authors.lastname: Vaghasia
authors.forename: Shreyasee
authors.initials: S
authors.lastname: Pradhan
authors.forename: Hilary
authors.initials: H
authors.lastname: Zelko
authors.forename: Ricardo
authors.initials: R
authors.lastname: Pietrobon
mesh_terms: D002986:Clinical Trials as Topic / Q000523:psychology*; D006801:Humans; D007194:India; D010358:Patient Participation / Q000523:psychology*; D011642:Publications; D015203:Reproducibility of Results