Abstract

*Dr. Pankaj A. Mandale, MBBS, MPH, DPB.

ABSTRACT

Clinical trials are vital in drug improvement and worldwide to assess varied populations. Today, scientific trials are massive and tightly regulated. Pharmaceutical organisations have to comply with moral requirements while keeping excessive epistemic standards. The lower and middle-income communities (LMIC) countries may be a lucrative destinations for clinical trials. People dwelling in such impoverished communities have limited healthcare support and economic constraints, thus inclining them to participate in the dangerous clinical practice compared to people from developed countries. Therefore, the ethical concern of proper awareness and benefits may be compromised. They may not ask or claim the benefits of participating in the clinical trial in situations of side effects or unforeseen outcomes that debilitate their health or well-being. While the centre of attention is on the moral or ethical medical trial implementation during the research development phase, there has to be an emphasis on monitoring the concern and welfare of the participants throughout the study. This article provides insights on several challenges and problems in conducting a clinical trial in LMIC and necessitating the essential monitoring obligations to make the trails safe and in the overall interest of humanity. Challenges beyond patient participation, monitoring, overlapping responsibilities, and lack of standards and safety measures. This article also tries to make an honest attempt to oversee some of these serious issues, challenges and ethical concerns in patients participating in the clinical trials from LMIC.