title: Trials and tribulations of conducting interventional studies in urban slums of a developing country: Experiences from Kolkata, India.
abstract: Experimental studies involving human subjects provide most internally valid evidences in epidemiological research due to their robust methodology. While conducting population-based interventional studies, to achieve external validity, inclusion of information from vulnerable groups like urban slum-dwellers of the developing world, in the epidemiological estimates is of paramount importance. The challenges faced while conducting 2 consecutive large-scale, community-based vaccine trials in urban slums of Kolkata, India are presented in this article. Interventions in these communities often get constrained by issues pertaining to human rights and benefits, socio-cultural factors, political environment, methodological shortcomings in addition to the challenges in ensuring community participation. While conducting these trials although we intermittently faced obstacles, by virtue of having a long term and robust surveillance system and developing a trusted relationship between the researchers, community leaders and residents we were able to come up with a commendable community participation which culminated into the success of the interventions. Bridging the gap between research and field operations by incorporating knowledge gathered from interventional studies and making strategies to improve health conditions of these informal settlers is a major unfulfilled agenda. We believe the lessons learnt during our research will help researchers while developing efficient interventions in similar setting.
authors.affiliation: a National Institute of Cholera and Enteric Diseases ; Kolkata , India.
authors.forename: Tanmay
authors.initials: T
authors.lastname: Mahapatra
authors.affiliation: a National Institute of Cholera and Enteric Diseases ; Kolkata , India.
authors.forename: Sanchita
authors.initials: S
authors.lastname: Mahapatra
authors.affiliation: a National Institute of Cholera and Enteric Diseases ; Kolkata , India.
authors.forename: Debottam
authors.initials: D
authors.lastname: Pal
authors.affiliation: a National Institute of Cholera and Enteric Diseases ; Kolkata , India.
authors.forename: Jayanta
authors.initials: J
authors.lastname: Saha
authors.affiliation: b University of the Philippines; National Institutes of Health ; Manila , Philippines.
authors.forename: AnnaLena
authors.initials: A
authors.lastname: Lopez
authors.affiliation: c International Vaccine Institute ; Seoul , Republic of Korea.
authors.forename: Mohammad
authors.initials: M
authors.lastname: Ali
authors.affiliation: a National Institute of Cholera and Enteric Diseases ; Kolkata , India.
authors.forename: Barnali
authors.initials: B
authors.lastname: Bannerjee
authors.affiliation: a National Institute of Cholera and Enteric Diseases ; Kolkata , India.
authors.forename: Byomkesh
authors.initials: B
authors.lastname: Manna
authors.affiliation: a National Institute of Cholera and Enteric Diseases ; Kolkata , India.
authors.forename: Dipika
authors.initials: D
authors.lastname: Sur
authors.affiliation: d The National Academy of Sciences ; Allahabad , Uttar Pradesh , India.
authors.forename: Sujit
authors.initials: S
authors.lastname: Bhattacharya
authors.affiliation: a National Institute of Cholera and Enteric Diseases ; Kolkata , India.
authors.forename: Suman
authors.initials: S
authors.lastname: Kanungo
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D003256:Community Participation; D003906:Developing Countries; D005260:Female; D006266:Health Education; D006801:Humans; D007194:India; D008297:Male; D008875:Middle Aged; D011204:Poverty Areas; D014505:Urban Population; D014612:Vaccines / Q000008:administration & dosage* / Q000276:immunology*; D055815:Young Adult
chemical_list: D014612:Vaccines
keywords: conducting vaccine trials; lessons from interventional studies; randomized control trial; trials and tribulations; urban slums