Clinical Trials

Biography

Biography: Wasif Ali Khan

Abstract

Lower costs to conduct clinical trials and availability of treatment-naïve patients have attracted many pharmaceutical companies to conduct clinical trials in developing countries in Africa, China, India, and parts of Eurasia. However, despite having a large patient base and diverse disease profiles, until recently Bangladesh could not appropriately participate in global clinical trials due to the lack of clinical research infrastructure. In a recently conducted study in lupus nephritis (LN) study conducted over 80 sites from 23 countries – Bangladesh was included as second tier when recruitment was alarmingly slow with the first tier. LN is a rare disease requiring the use of a global approach to recruitment. The total time required in Bangladesh to obtain central as well as the site IRB approvals was 4 months. Although the initial country target was to enroll a maximum of 25 patients from Bangladesh, quality in clinical care and ensuring the ICH-GCP guidelines were closely and constantly maintained allowed for an increase in countrywide enrollment. This resulted in ultimate highest patient enrollment from Bangladesh (n=46) out of total n=265 patients enrolled globally. In this study 80% of clinical studies fail to meet enrollment deadlines, and 50% of sites enroll 1 or no patients. Bangladesh a country of over 160 million with many treatment naïve patients; increased number of lifestyle diseases are emerging with the change of the economy of the country from low to middle income country. Young physician Investigator has the medical training in English and trained in the same standard as UK Investigators. The combination of population availability, high quality Investigators and the common use of English points to Bangladesh as a potential new hub for international clinical trials and global CROs to explore in this newly emerged clinical research country. That results in faster recruitment, saving unnecessary investigations and reducing overall study cost. Most importantly new drugs those are in the pipeline are evaluated much faster through Clinical trials for regulatory approval and thus the neediest patients are privileged with newer medicines that could benefit both morbidity and mortality.