224
Views
6
CrossRef citations to date
0
Altmetric
Original Research

Factors Influencing Participation Of Healthy Volunteers In Clinical Trials: Findings From A Cross-Sectional Study In Delhi, North India

, , , &
Pages 2007-2015 | Published online: 29 Nov 2019

References

  • Umscheid CA, Margolis DJ, Grossman CE. Key concepts of clinical trials: a narrative review. Postgrad Med. 2011;123(5):194–204. doi:10.3810/pgm.2011.09.247521904102
  • Yip C, Han NLR, Leong Sng B. Legal and ethical issues in research. Indian J Anaesth. 2016;60(9):684–688. doi:10.4103/0019-5049.19062727729698
  • World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310:2191–2194.24141714
  • Grover S, Xu M, Jhingran A, et al. Clinical trials in low and middle-income countries - successes and challenges. Gynecol Oncol Rep. 2016;19:5–9. doi:10.1016/j.gore.2016.11.00728004030
  • Devasenapathy N, Singh K, Prabhakaran D. Conduct of clinical trials in developing countries: a perspective. Curr Opin Cardiol. 2009;24(4):295–300.19444095
  • Gaul C, Schmidt T, Helm J, Hoyer H, Haerting J. Motivation and barriers to participation in clinical trials. Med Klin (Munich). 2006;101(11):873–879. doi:10.1007/s00063-006-1116-717235473
  • Weigmann K. The ethics of global clinical trials. EMBO Rep. 2015;16(5):566–570. doi:10.15252/embr.20154039825851646
  • Emanuel EJ, Wendler D, Killen J, Grady C. What makes clinical research in developing countries ethical? The benchmarks of ethical research. J Infect Dis. 2004;189(5):930–937. doi:10.1086/jid.2004.189.issue-514976611
  • Almeida L, Azevedo B, Nunes T, Vaz-da-silva M, Soares-da-silva P. Why healthy subjects volunteer for phase I studies and how they perceive their participation? Eur J Clin Pharmacol. 2007;63(11):1085–1094. doi:10.1007/s00228-007-0368-317891536
  • Kass NE, Myers R, Fuchs EJ, Carson KA, Flexner C. Balancing justice and autonomy in clinical research with healthy volunteers. Clin Pharmacol Ther. 2007;82(2):219–227. doi:10.1038/sj.clpt.610019217410122
  • van Gelderen CE, Savelkoul TJ, van Dokkum W, Meulenbelt J. Motives and perception of healthy volunteers who participate in experiments. Eur J Clin Pharmacol. 1993;45(1):15–21. doi:10.1007/BF003153448405024
  • Madsen SM, Mirza MR, Holm S, Hilsted KL, Kampmann K, Riis P. Attitudes towards clinical research amongst participants and nonparticipants. J Intern Med. 2002;251(2):156–168. doi:10.1046/j.1365-2796.2002.00949.x11905591
  • Agrawal M, Grady C, Fairclough DL, Meropol NJ, Maynard K, Emanuel EJ. Patients’ decision-making process regarding participation in phase I oncology research. J Clin Oncol. 2006;24(27):4479–4484. doi:10.1200/JCO.2006.06.026916983117
  • Vetchý D, Frýbortová K, Rabisková M, Daneckova H. Bioequivalence studies of pharmaceutical preparations. Cas Lek Cesk. 2007;146(5):431–433.17554963
  • Galgatte Upendra C. Study on requirements of bioequivalence for registration of pharmaceutical products in India, South-Africa and Australia. Am J PharmTech Res. 2013;3(1):289–305.
  • Novak E, Seckman CE, Stewart RD. Motivations for volunteering as research subjects. J Clin Pharmacol. 1977;17(7):365–371. doi:10.1002/jcph.1977.17.issue-7881469
  • Vrhovac R, Francetic I, Rotim K. Drug trials on healthy volunteers in Yugoslavia. Int J Clin Pharmacol Ther Toxicol. 1990;28(9):375–379.2228323
  • Tishler CL, Bartholomae S. Repeat participation among normal healthy research volunteers: professional guinea pigs in clinical trials? Perspect Biol Med. 2003;46(4):508–520. doi:10.1353/pbm.2003.009414593220
  • Lemmens T, Elliott C. Guinea pigs on the payroll: the ethics of paying research subjects. Account Res. 1999;7(1):3–20. doi:10.1080/0898962990857393911657561
  • Tishler CL, Bartholomae S. The recruitment of normal healthy volunteers: a review of the literature on the use of financial incentives. J Clin Pharmacol. 2002;42(4):365–375. doi:10.1177/0091270022201140911936560
  • Stunkel L, Grady C. More than the money: a review of the literature examining healthy volunteer motivations. Contemp Clin Trials. 2011;32(3):342–352. doi:10.1016/j.cct.2010.12.00321146635
  • Joseph J. Entering the contract research industry in India. Contem Clin Trials. 2008;29:311–313. doi:10.1016/j.cct.2007.10.006
  • Gupta YK, Padhy BM. India’s growing participation in global clinical trials. Trends Pharmacol Sci. 2011;32(6):327–329. doi:10.1016/j.tips.2011.02.01721489644
  • Harapan H, Anwar S, Bustaman A, et al. Community willingness to participate in a dengue study in Aceh Province, Indonesia. PLoS ONE. 2016;11(7):e0159139 Published 2016 Jul 12. doi:10.1371/journal.pone.015913927404663
  • Harapan H, Mudatsir M, Yufika A, et al. Willingness to participate and associated factors in a zika vaccine trial in Indonesia: a cross-sectional study. Viruses. 2018;10(11):648 Published 2018 Nov 18. doi:10.3390/v10110648
  • Gitanjali B, Raveendran R, Pandian DG, Sujindra S. Recruitment of subjects for clinical trials after informed consent: does gender and educational status make a difference? J Postgrad Med. 2003;49:109–113.12867683
  • Catania C, De Pas T, Goldhirsch A, et al. Participation in clinical trials as viewed by the patient: understanding cultural and emotional aspects which influence choice. Oncology. 2008;74:177–187. doi:10.1159/00015136518714166
  • Unson CG, Ohannessian C, Kenyon L, Case A, Reisine S, Prestwood K. Barriers to eligibility and enrollment among older women in a clinical trial on osteoporosis: effects of ethnicity and SES. J Aging Health. 2004;16:426–443. doi:10.1177/089826430426421115155070
  • Shah JY, Phadtare A, Rajgor D, et al. What leads Indians to participate in clinical trials? A meta-analysis of qualitative studies. PLoS ONE. 2010;5(5):e10730. doi:10.1371/journal.pone.001073020505754
  • Walsh JA, Nash MM. Personality characteristics of volunteers for medical research. Crim Justice Behav. 1978;5(2):99–116. doi:10.1177/00938548780050020111662773
  • Nappo SA, Iafrate GB, Sanchez ZM. Motives for participating in a clinical research trial: a pilot study in Brazil. BMC Public Health. 2013;13:19. doi:10.1186/1471-2458-13-1923302375
  • Berg SL, Winick N, Ingle AM, Adamson PC, Blaney SC. Reasons for participation in optional pharmacokinetic studies in children with cancer: a Children’s Oncology Group phase 1 consortium study. Pediatr Blood Cancer. 2010;55(1):119–122. doi:10.1002/pbc.2252920486176