CLINICAL TRIALS: PERSPECTIVES OF MEDICAL COMMUNITY
Objective: The objective of the study was to determine the knowledge, attitude, and perception about clinical trials (CTs) among medical community of a tertiary care institution.
Methodology: This was a questionnaire-based cross-sectional study conducted in the Department of Pharmacology, Government Medical College in Central Kerala for a period of 1 year. In a sample population of 690 comprising medical undergraduates (3rd phase), residents, and doctors in Medical Education Service (MES), 309 questionnaires were distributed randomly assuming 80% response to achieve the sample size of 247. Knowledge, attitude, and perceptions were quantified with a cumulative score with a scoring scheme of +1 for a correct response/positive attitude/positive perception and 0 for an incorrect response/no response/negative attitude/negative perception. The data were analyzed using SPSS 16, the knowledge, attitude, and perception were expressed as mean score as well as proportion.
Results: The response rate was 95.79%. Of the 296 completed responses, 158 (53.4%) were from medical undergraduates, 62 (20.9%) from residents, and 76 (25.7%) from doctors in MES. The mean knowledge was 14.8±3.79 (maximum score 25). The mean attitudinal score was 7.07±1.82 (maximum score 10). The mean score of the participants on perception (maximum score=10) about CTs conducted in India was 4.11±2.02 which denoted a negative perception.
Conclusion: The participants had good knowledge and positive attitude about CTs, however, all the three groups of participants had negative perception about CTs currently conducted in India.
2. Gilman G. Drug Invention and the Pharmaceutical Industry. The Pharmacological Basis of Therapeutics. 13th ed. New York: McGraw Hill Medical; 2018. p. 6.
3. World Health Organization. Everybody’s Business: Strengthening Health Systems to Improve Health Outcomes. WHO’s Frame Work for Action. Geneva: World Health Organization; 2007. Available from: https://www.who.int/healthsystems/strategy/everybodys_business. pdf?ua=1. [Last accessed on 2020 Jun 06].
4. Odutola AB. Developing countries must invest in access to information for health improvements. J Med Internet Res 2003;5:e5.
5. Choudhury S, Pradhan R, Dubey L, Barman L, Biswas T, Das M, et al. Knowledge and perception regarding clinical trials among doctors of government Medical colleges: A questionnaire-based study. Perspect Clin Res 2016;7:94-9.
6. Choi YJ, Beck SH, Kang WY, Yoo S, Kim SY, Lee JS, et al. Knowledge and perception about clinical research shapes behavior: Face to face survey in Korean general public. J Korean Med Sci 2016;31:674-81.
7. Anderson A, Borfitz D, Getz K. Global public attitudes about clinical research and patient experiences with clinical trials. JAMA Netw Open 2018;1:e182969.
8. Pawar DB, Gawde SR, Marathe PA. Awareness about medical research among resident doctors in a tertiary care hospital: A cross-sectional survey. Perspect Clin Res 2012;3:57-61.
9. Sample Size Calculator; 2020. Available from: https://www. surveysystem.com/sscalc.htm. [Last accessed on 2020 Mar 28].
10. Deodurg PM, Bagewadi HG, Patil BV, Dass AP. Knowledge, attitude and perceptions of 3rd term medical students towards clinical trials in a medical college in southern India. Indian J Pharm Pharmacol 2017;4:125-9.
11. The Report of the Prof Ranjit Roy Chaudhury Expert Committee to Formulate Policy and Guidelines for Approval of New Drugs, Clinical Trials and Banning of Drugs; 2020. Available from: http://www.cdsco. nic.in/writereaddata/report_of_dr_ranjit_roy.pdf. [Last accessed on 2020 Mar 28].
12. Rahman S, Majumder MA, Shaban SF, Rahman N, Ahmed M, Bin K, et al. Physician participation in clinical research and trials: Issues and approaches. Adv Med Educ Pract 2011;2:85-93.
13. Kanna RS, Alla J, Krishnakanth K. Knowledge of medical students on clinical trials. Int J Basic Clin Pharmacol 2019;8:1484-8.
14. Abushouk AI, Hatata AN, Omran IM, Youniss MM, Elmansy KF, Meawad AG. Attitudes and perceived barriers among medical students towards clinical research: A cross-sectional study in an Egyptian medical school. J Biomed Educ 2016;2016:5490575.
15. Kiruthika S, Vijayalakshmi S, Geetha K, Parameswari R. A study to assess the knowledge of medical students on clinical trials in Madurai medical college. Int J Sci Res 2016;5:1-3.
16. Medical Council of India. Competency Based Undergraduate Curriculum for the Indian Medical Graduate. Vol. 1. India: Medical Council of India; 2018. Available from: https://www.mciindia.org/cms/ wp-content/uploads/2019/01/ug-curriculum-vol-i.pdf. [Last accessed on 2020 Mar 28].
17. Sharma KH, Jindal A. Low awareness of clinical research in India amongst final year medical students and physicians: Need for increased emphasis on clinical research in medical curriculum. Arch Med Health Sci 2014;2:234.
18. Indian Council of Medical Research. Short Term Studentship. India: Indian Council of Medical Research; 2020. Available from: http://188.8.131.52:84/ about_uspage.aspx. [Last accessed on 2020 Mar 28].
19. Dhodi DK, Thakkar KB, Billa G, Khobragade AA, Sinha SR, Patel SB. Knowledge, attitude and practices of medical students and teachers towards clinical research in a tertiary care hospital in Mumbai-cross sectional survey. J Contemp Med Educ 2013;1:238-44.
20. Vittalrao AM, Kumari KM, Bhat SV, Gill R, Thomson SR. A questionnaire survey on awareness of clinical trials among medical students. Biomed Pharmacol J 2018;11:2005-9.
21. Khalaf AJ, Aljowder AI, Buhamaid MJ, Alansari MF, Jassim GA. Attitudes and barriers towards conducting research amongst primary care physicians in Bahrain: A cross-sectional study. BMC Fam Pract 2019;20:20.
22. Chung SH, Kim EJ, Jeong SH, Park GL. Factors associated with willingness to participate in clinical trials: A nationwide survey study. BMC Public Health 2015;15:10.
23. Kadam RA, Borde SU, Madas SA, Salvi SS, Limaye SS. Challenges in recruitment and retention of clinical trial subjects. Perspect Clin Res 2016;7:137-43.
24. Nijhawan LP, Janodia MD, Muddukrishna BS, Bhat KM, Bairy KL, Udupa N, et al. Informed consent: Issues and challenges. J Adv Pharm Technol Res 2013;4:134-40.
25. Kravitz RL, Paterniti DA, Hay MC, Subramanian S, Dean DE, Weisner T, et al. Marketing therapeutic precision: Potential facilitators and barriers to adoption of n-of-1 trials. Contemp Clin Trials 2009;30:436-45.
This work is licensed under a Creative Commons Attribution 4.0 International License.
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.