- Feb. 23, 2021
-- Diseases are the major cause of sufferings and socio-economic disruptions worldwide. With the emergence of new and unknown diseases as well as growing ineffectiveness of the existing medicines, we are on a crossroads of looming uncertainty. However, the bottom line is that most of the diseases can be cured through the availability of effective and affordable medicines. The word "Clinical trials" relates to the science of bringing out newer, better and safe medicines to serve the mankind. Typically, it takes approximately 12 years and millions of dollars to bring one new drug from conception to market out of which 6–7 years are spent in various phases of clinical trials. Clinical trials are conducted in four different phases (I, II, III, and IV), where each phase is aimed at addressing a scientific question. While the initial safety of a new drug is established in phase-I of clinical trial the later phases establish the efficacy of the drug along with the safety. As clinical trials are conducted in a phase-wise manner, the next phase is initiated only if the drug passes the earlier phase.
Site ClinicalTrials.gov (a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world) enlists a total of 35520 and 36743 clinical studies across 219 countries for the year 2019 and 2020. Of the 35520 clinical studies registered during the year 2019, cancer tops the therapeutic area list with 19.5% share followed by cardiovascular diseases (11.1%), respiratory (7.7%), central nervous system (7.5%), infectious diseases (7.2%) and diabetes (3.9%). As compared to 2019, the year 2020 witnessed a 13% growth in the total number of studies with a surge in the clinical studies on infectious diseases. The therapeutic area-wise distribution of these studies once again reveals a highest share for cancer studies (18.9%) followed by cardiovascular diseases (10.5%), respiratory (10.3%), infectious diseases (10.3%), central nervous system (6.9%), and diabetes (3.4%). The phase-wise distribution of these studies during the last two years reveals a maximum number of studies in Phase II (12.3% and 13.3%) followed by Phase I (9.5% and 9.2%), Phase III (6.0% and 6.4%) and Phase IV (4.7% and 4.3%) respectively. With a listing of 281 (0.86%) and 306 (0.83%) studies for the year 2019 and 2020, India represents a participation of less than 1% in these studies.
With the availability of a large pool of GCP trained investigators and clinical research professionals, India can contribute significantly to the global drug development programs. The recent example in the domain of COVID-19 vaccine manufacturing has already demonstrated the supremacy of Indian pharmaceutical industry to the rest of the world and there is no reason why clinical research can't follow the footsteps.