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

PLoS ONE

Volumn 5, Issue 5, 2010, Pages

  Shah, Jatin Y ^a,b   Phadtare, Amruta ^b,c   Rajgor, Dimple ^a,b   Vaghasia, Meenakshi ^b,c   Pradhan, Shreyasee ^a,b   Zelko, Hilary ^b,d   Pietrobon, Ricardo ^a,b,d  

^a DUKE NUS MEDICAL SCHOOL   (Singapore)

^b DUKE UNIVERSITY   (United States)

^c Kalpavriksha Healthcare and Research   (India)

^d DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALTRUISM; ARTICLE; CLINICAL STUDY; COMMUNICATION DISORDER; CONFIDENTIALITY; DOCTOR PATIENT RELATION; ETHNICITY; HEALTH INSURANCE; HUMAN; INDIAN; MOTIVATION; PATIENT DECISION MAKING; PATIENT EDUCATION; PATIENT PARTICIPATION; PATIENT SAFETY; PATIENT SELECTION; PSYCHOLOGICAL ASPECT; QUALITATIVE ANALYSIS; RESEARCH SUBJECT; SOCIAL STATUS; CLINICAL TRIAL; INDIA; META ANALYSIS; PUBLICATION; REPRODUCIBILITY;

CLINICAL TRIALS AS TOPIC; HUMANS; INDIA; PATIENT PARTICIPATION; PUBLICATIONS; REPRODUCIBILITY OF RESULTS;

EID: 77956292107     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0010730     Document Type: Article

References (77)

1. Campbell MK, Snowdon C, Francis D, Elbourne D, McDonald AM, et al. (2007) Recruitment to randomised trials: strategies for trial enrollment and participation study. The STEPS study. Health Technology Assessment (Winchester, England) 11: iii, ix-105-iii, ix-105.
2. Wallace K, Fleshner N, Jewett M, Basiuk J, Crook J (2006) Impact of a multidisciplinary patient education session on accrual to a difficult clinical trial: the Toronto experience with the surgical prostatectomy versus interstitial radiation intervention trial. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology 24: 4158-4162.
3. Kimmick GG, Peterson BL, Kornblith AB, Mandelblatt J, Johnson JL, et al. (2005) Improving accrual of older persons to cancer treatment trials: a randomized trial comparing an educational intervention with standard information: CALGB 360001. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology 23: 2201-2207.
4. Shaw PH, Ritchey AK (2007) Different rates of clinical trial enrollment between adolescents and young adults aged 15 to 22 years old and children under 15 years old with cancer at a children's hospital. Journal of Pediatric Hematology/ Oncology: Official Journal of the American Society of Pediatric Hematology/ Oncology 29: 811-814.
5. Cambron JA (2001) Recruitment and accrual of women in a randomized controlled trial of spinal manipulation. Journal of Manipulative and Physiological Therapeutics 24: 79-83.
6. Wood CG, Wei SJ, Hampshire MK, Devine PA, Metz JM (Dec 2006) The influence of race on the attitudes of radiation oncology patients towards clinical trial enrollment. Am J Clin Oncol 29: 593-599.
7. Buchbinder SP, Metch B, Holte SE, Scheer S, Coletti A, et al. (2004) Determinants of enrollment in a preventive HIV vaccine trial: hypothetical versus actual willingness and barriers to participation. Journal of Acquired Immune Deficiency Syndromes (1999) 36: 604-612.
8. Unson CG, Ohannessian C, Kenyon L, Case A, Reisine S, et al. (2004) Barriers to eligibility and enrollment among older women in a clinical trial on osteoporosis: effects of ethnicity and SES. Journal of Aging and Health 16: 426-443.
9. Umutyan A, Chiechi C, Beckett LA, Paterniti DA, Turrell C, et al. (2008) Overcoming barriers to cancer clinical trial accrual: impact of a mass media campaign. Cancer 112: 212-219.
10. King WD, Defreitas D, Smith K, Andersen J, Perry LP, et al. (2007) Attitudes and perceptions of AIDS clinical trials group site coordinators on HIV clinical trial recruitment and retention: a descriptive study. AIDS Patient Care and STDs 21: 551-563.
11. Lara PN, Higdon R, Lim N, Kwan K, Tanaka M, et al. (2001) Prospective evaluation of cancer clinical trial accrual patterns: identifying potential barriers to enrollment. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology 19: 1728-1733.
12. Palmas W, Teresi J, Morin P, Wolff LT, Field L, et al. (2006) Recruitment and enrollment of rural and urban medically underserved elderly into a randomized trial of telemedicine case management for diabetes care. Telemedicine Journal and E-Health: The Official Journal of the American Telemedicine Association 12: 601-607.
13. Thiers FA, Sinskey AJ, Berndt ER (2007) Trends in the globalization of clinical trials. Nat Rev Drug Discov 7: 13-14.
14. Joseph J (2008) Entering the contract research industry in India. Contemporary Clinical Trials 29: 311-313.
15. Tomlinson H (2004) Drugs giant moves trials abroad: Glaxo lured by security and low costs of trials overseas. Guardian.co.uk.
16. Don M Clinical trials and safety reporting under Schedule Y. Pharmabiz.com.
17. Cyberlaw Candice Player: Outsourcing Clinical Trials to India. Berkman http://cyber.law.harvard.edu/cyberlaw2005/Candice_Player:_Outsourcing_Clinical_Trials_to_India.
18. Nundy S, Chir M, Gulathi CM (2005) A New Colonialism? - Conducting Clinical Trials in India. N Engl J Med 352: 1633-1636.
19. Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harrington RA, et al. (2009) Ethical and Scientific Implications of the Globalization of Clinical Research. The New England Journal of Medicine 360: 816-823.
20. Catania C, DP T, Goldhirsch A, Radice D, Adamoli L, Medici M, et al. (2008) Participation in clinical trials as viewed by the patient: understanding cultural and emotional aspects which influence choice. Oncology 74: 177-187.
21. LaVallie DL, Wolf FM, Jacobsen C, Buchwald D (2008) Barriers to cancer clinical trial participation among Native elders. Ethnicity & Disease 18: 210-217.
22. Jones JM, Nyhof-Young J, Moric J, Friedman A, Wells W, et al. (2006) Identifying motivations and barriers to patient participation in clinical trials. Journal of Cancer Education: The Official Journal of the American Association for Cancer Education 21: 237-242.
23. Shavers VL, Lynch CF, Burmeister LF (2002) Racial differences in factors that influence the willingness to participate in medical research studies. Annals of Epidemiology 12: 248-256.
24. Gitanjali B, Raveendran R, Pandian DG, Sujindra S (2003) Recruitment of subjects for clinical trials after informed consent: does gender and educational status make a difference? Journal of Postgraduate Medicine 49: 109-113.
25. Tu S-P, Chen H, Chen A, Lim J, May S, et al. (2005) Clinical trials: understanding and perceptions of female Chinese-American cancer patients. Cancer 104: 2999-3005.
26. Buchwald D, Mendoza-Jenkins V, Croy C, McGough H, Bezdek M, et al. (2006) Attitudes of Urban American Indians and Alaska Natives Regarding Participation in Research. Journal of General Internal Medicine 21: 648-651.
27. Russell KM, Maraj MS, Wilson LR, Shedd-Steele R, Champion VL (2008) Barriers to recruiting urban African American women into research studies in community settings. Applied Nursing Research: ANR 21: 90-97.
28. Wilbur W (2005) Modeling Text Retrieval in Biomedicine. Medical Informatics. pp 277-297.
29. Mynatt CR, Doherty ME, Tweney RD (1978) Consequences of confirmation and disconfirmation in a simulated research environment. Quarterly Journal of Experimental Psychology 30: 395-395.
30. Nickerson RS (1998) Confirmation bias: A ubiquitous phenomenon in many guises. Review of General Psychology 2: 175-220.
31. Hussain-Gambles M, Leese B, Atkin K, Brown J, Mason S, et al. (2004) Involving South Asian patients in clinical trials. Health Technology Assessment (Winchester, England) 8: iii, 1-109-iii, 101-109.
32. Hussain-Gambles M (2004) South Asian patients' views and experiences of clinical trial participation. Family Practice 21: 636-642.
33. Hussain-Gambles M, Atkin K, Leese B (2006) South Asian participation in clinical trials: The views of lay people and health professionals. Health Policy 77: 149-165.
34. Sahay S, Mehendale S, Sane S, Brahme R, Brown A, et al. (2005) Correlates of HIV vaccine trial participation: an Indian perspective. Vaccine 23: 1351-1358.
35. Suhadev M, Nyamathi AM, Swaminathan S, Venkatesan P, Sakthivel MR, et al. (2006) A pilot study on willingness to participate in future preventive HIV vaccine trials. Indian J Med Res 124: 631-640.
36. Harris Interactive (2005) Participation in Clinical Trials Lower in Europe and India than in the United States. Harris Interactive studies public perceptions of clinical trialsin six European countries and India. Healthcare News 5.
37. Nyamathi AM, Suhadev M, Swaminathan S, Fahey JL (2007) Perceptions of a community sample about participation in future HIV vaccine trials in south India. AIDS and Behavior 11: 619-627.
38. Harris interactive Available: http://www.harrisinteractive.com.
39. Wong ML, Chia KS, Wee S, Chia SE, Lee J, et al. (2004) Concerns over participation in genetic research among Malay-Muslims, Chinese and Indians in Singapore: a focus group study. Community Genetics 7: 44-54.
40. Roberson NL (1994) Clinical trial participation. Viewpoints from racial/ethnic groups. Cancer 74: 2687-2691.
41. Lee SJ, Lenert L, Weisman S, Kavanaugh A (2005) Factors affecting rheumatoid arthritis patients' decisions to participate in clinical trials. The Journal of Rheumatology 32: 2317-2325.
42. Wendler D, Krohmal B, Emanuel EJ, Grady C (2008) Why patients continue to participate in clinical research. Archives of Internal Medicine 168: 1294-1299.
43. Pentz RD, Flamm AL, Sugarman J, Cohen MZ, Daniel Ayers G, et al. (2002) Study of the media's potential influence on prospective research participants' understanding of and motivations for participation in a high-profile phase I trial. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology 20: 3785-3791.
44. Halpern SD, Karlawish JHT, Casarett D, Berlin JA, Townsend RR, et al. (2003) Hypertensive patients' willingness to participate in placebo-controlled trials: implications for recruitment efficiency. American Heart Journal 146: 985-992.
45. Schutta KM, Burnett CB (2000) Factors that influence a patient's decision to participate in a phase I cancer clinical trial. Oncology Nursing Forum 27: 1435-1438.
46. Kennedy BM, Burnett MF (2007) Clinical research trials: factors that influence and hinder participation. Journal of Cultural Diversity 14: 141-147.
47. Rojavin MA, Downs P, Shetzline MA, Chilingerian R, Cohard-Radice M (2006) Factors motivating dyspepsia patients to enter clinical research. Contemporary Clinical Trials 27: 103-111.
48. Khaliq W, Gross M, Thyagarajan B, Jones-Webb R (2003) What motivates minorities to participate in research? Minnesota Medicine 86: 39-42.
49. Koblin BA, Heagerty P, Sheon A, Buchbinder S, Celum C, et al. (1998) Readiness of high-risk populations in the HIV Network for Prevention Trials to participate in HIV vaccine efficacy trials in the United States. AIDS 12: 785-793.
50. Harrison LH, do Lago RF, Friedman RK, Rodrigues J, Santos EM, et al. (1999) Incident HIV infection in a high-risk, homosexual, male cohort in Rio de Janeiro, Brazil. Journal of Acquired Immune Deficiency Syndromes 21: 408-412.
51. Périssé AR, Schechter M, Moreira RI, do Lago RF, Santoro-Lopes G, et al. (2000) Willingness to participate in HIV vaccine trials among men who have sex with men in Rio de Janeiro, Brazil. Projeto Praça Onze Study Group. Journal of Acquired Immune Deficiency Syndromes (1999) 25: 459-463.
52. Coyne CA, Demian-Popescu C, Brown P (2004) Rural cancer patients' perspectives on clinical trials: a qualitative study. Journal of Cancer Education: The Official Journal of the American Association for Cancer Education 19: 165-169.
53. Diaz VA, Mainous AG, McCall AA, Geesey ME (2008) Factors affecting research participation in African American college students. Family Medicine 40: 46-51.
54. Avis NE, Smith KW, Link CL, Hortobagyi GN, Rivera E (2006) Factors associated with participation in breast cancer treatment clinical trials. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology 24: 1860-1867.
55. Townsley CA, Chan KK, Pond GR, Marquez C, Siu LL, et al. (2006) Understanding the attitudes of the elderly towards enrolment into cancer clinical trials. BMC Cancer 6: 34.
56. Mills EJ, Seely D, Rachlis B, Griffith L, Wu P, et al. (2006) Barriers to participation in clinical trials of cancer: a meta-analysis and systematic review of patient-reported factors. The Lancet Oncology 7: 141-148.
57. Wasan AD, Taubenberger SP, Robinson WM (2009) Reasons for participation in pain research: can they indicate a lack of informed consent? Pain Medicine (Malden, Mass) 10: 111-119.
58. Grady C (2001) Money for Research Participation: Does It Jeopardize Informed Consent? The American Journal of Bioethics 1: 40-44.
59. Swanson GM, Ward AJ (1995) Recruiting minorities into clinical trials: toward a participant-friendly system. Journal of the National Cancer Institute 87: 1747-1759.
60. Shavers VL, Lynch CF, Burmeister LF (2000) Knowledge of the Tuskegee study and its impact on the willingness to participate in medical research studies. Journal of the National Medical Association 92: 563-572.
61. Corbie-Smith G, Thomas SB, Williams MV, Moody-Ayers S (1999) Attitudes and Beliefs of African Americans Toward Participation in Medical Research. Journal of General Internal Medicine 14: 537-546.
62. Braunstein JB, Sherber NS, Schulman SP, Ding EL, Powe NR (2008) Race, medical researcher distrust, perceived harm, and willingness to participate in cardiovascular prevention trials. Medicine 87: 1-9.
63. Sengupta S, Strauss RP, DeVellis R, Quinn SC, DeVellis B, et al. (2000) Factors affecting African-American participation in AIDS research. Journal of Acquired Immune Deficiency Syndromes 24: 275-284.
64. Murthy VH, Krumholz HM, Gross CP (2004) Participation in cancer clinical trials: race-, sex-, and age-based disparities. JAMA: The Journal of the American Medical Association 291: 2720-2726.
65. Ellington L, Wahab S, Sahami Martin S, Field R, Mooney KH (2006) Factors that influence Spanish- and English-speaking participants' decision to enroll in cancer randomized clinical trials. Psycho-Oncology 15: 273-284.
66. Donovan J, Mills N, Smith M, Brindle L, Jacoby A, et al. (2002) Quality improvement report: Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. Commentary: presenting unbiased information to patients can be difficult. BMJ (Clinical Research Ed) 325: 766-770.
67. Crawley LM (2001) African-American participation in clinical trials: situating trust and trustworthiness. Journal of the National Medical Association 93: 14S-17S.
68. O'Connell JM, Hogg RS, Chan K, Strathdee SA, McLean N, et al. (2002) Willingness to participate and enroll in a phase 3 preventive HIV-1 vaccine trial. Journal of Acquired Immune Deficiency Syndromes 31: 521-528.
69. Horowitz HS (1978) Overview of ethical issues in clinical studies. Journal of Public Health Dentistry 38: 35-43.
70. Dworkin G. Autonomy and informed consent. In: Abram MB, Ballantine HT, Dunlop GR, et al., eds. (1982) Making health care decisions, the ethical and legal implications of informed consent in the patient-practitioner relationship. The President's Commission for the study of ethical problems in medicine and biomedical and behavioral research. Washington, DC: U.S. Government Printing Office. pp 63-81.
71. Hahn RA (1982) Culture and informed consent: an anthropological perspective. In: Abram MB, Ballantine HT, Dunlop GR, et al., eds. Making health care decisions, the ethical and legal implications of informed consent in the patientpractitioner relationship. The President's Commission for the study of ethical problems in medicine and biomedical and behavioral research. Washington, DC: U.S. Government Printing Office. pp 37-62.
72. Meisel A, Kuczewski M (1996) Legal and ethical myths about informed consent. Archives of Internal Medicine 156: 2521-2526.
73. Marshall SL, While AE (1994) Interviewing respondents who have English as a second language: challenges encountered and suggestions for other researchers. Journal of Advanced Nursing 19: 566-571.
74. Homer C (2000) Incorporating cultural diversity in randomised controlled trials in midwifery. Midwifery 16: 252-259.
75. Shah J, Shah A, Pietrobon R (2009) Scientific writing of novice researchers: what difficulties and encouragements do they encounter? Academic Medicine: Journal of the Association of American Medical Colleges 84: 511-516.
76. Pietrobon R, Guller U, Martins H, Menezes A, Higgins L, et al. (2004) A suite of web applications to streamline the interdisciplinary collaboration in secondary data analyses. BMC Medical Research Methodology 4: 29-29.
77. Duke University Health System Available: http://researchonresearch.org/