Clinical trial challenges in LMIC.

Abstract

e23025 Background: Clinical trials are crucial for advancing medical knowledge and creating novel therapeutic interventions; however, they also present several challenges when conducted in tertiary care hospitals. Ethical and regulatory requirements frequently cause delays in trial approval and increase administrative burden. Finding and keeping eligible participants remains a major problem because of patient concerns, misunderstandings about clinical research, and the complexity of trial protocols. Sometimes, trials are not started because the sponsor decides to halt them without any communication. The sponsor excluded some patients according to their site preferences. In this study, we review these challenges. Methods: Records from the research department, ethics committee, and trial coordinators were used as information sources. All clinical trials that were submitted to the hospital within the previous 12 months were examined. Data were analysed using a standard questionnaire. The questions were related to feasibility completion, site evaluation, site initiation, ethics committee approval, and formal initiation of the trial. Results: Over a period of one year, a total of 31 proposals for clinical trials were received. The feasibility questionnaire was replicated well over time. Only 18 sponsors responded after feasibility completion. No return communication was received for the remaining 13 proposals. Only 11 out of 18 proposals were granted permission to go ahead by the institutional ethics committee. The reasons for not approving other trials were non-allowance of sample export, non-availability of ethics approval from other sites, being a phase I trial, and non-acceptance of the science behind the trial. The average time from feasibility to approval was three months. Only 7 of the trials that were initiated are still in progress. Four trials, despite approval, were not able to proceed due to a lack of patient accrual and preferential selection from other sites. In conclusion, less than 25% (7/31) of the trials could be initiated due to various challenges. Conclusions: The clinical trial process requires a long time in institutions. Loss of communication from sponsors is common. Ethics rejection needs to be better understood, and measures are required to improve acceptance. The site preferences of sponsors are also challenging. Overall, the clinical trial process needs more standardization and is driven by science.