M 25: Do Clinical Trials Conducted in India Match its Health Care Needs? An Audit of Two Clinical Trials Registries
Student, Department of Clinical Pharmacology
Seth GS Medical College and KEM Hospital India
To assess the relevance of the clinical trials conducted in India to its healthcare needs by evaluating studies registered in the Indian Clinical Trial Registry (CTRI) and compare them to those registered in clinicaltrials.gov, U.S.A.
Regulatory studies registered between 2007 and 2015 were analyzed for year of registration, phase of development and disease burden in India (as assessed by therapeutic area of the trial), state where conducted (relative to its population). Data from the two registries was compared.
The CTRI had 3325 regulatory studies registered during the study period. From 27 in 2007, the number rose to a maximum of 550 in 2010. There was a fall over the next two years (363, 394), which rose again to 404 in 2015. Phase III trials were the maximum , followed by Phase IV (783), Phase II (778), and Phase I (214). The year wise trend for the various phases was similar to that seen with the total. The state of Maharashtra had the highest number trials registered (1666) followed by Karnataka (1175) and Tamil Nadu (1004). Populous states like Uttar Pradesh (544) and Bihar (138) had far fewer trials. The North-Eastern states had no trials at all.
Disease burden expressed as Disability Adjusted Life Years [DALYs (‘000)] was maximum for infectious/parasitic diseases (82,681.3), followed by neonatal conditions (66591.9), and nutritional deficiencies (19731.3). However, the number of trials in these areas was insignificant. Oncology accounted for high DALYs (24015) and also had the largest number of clinical trials [440 (13.23%)] in any therapeutic area. This was reflected in the Phase wise distribution as well with most Phase II (126) and Phase III (227) trials being in oncology. Phase III trials were also conducted in other areas that contributed to high DALYs like diabetes mellitus (148 trials, 9795.5 DALYs), pulmonology (111 trials, 41938 DALYs), musculoskeletal disorders (93 trials, 10368.4 DALYs) and digestive diseases (90 trials, 17771.3). Most Phase I trials were on vaccines (42), while most Phase IV trials were in diabetes (61).
A total of 1875 trials were registered from India in clinicaltrials.gov with the number being 230 in 2007. This number steadily rose to a maximum of 296 in 2010 after which the numbers fell only 90 in 2015. Most of the trials were Phase III (862) followed by Phase II (449), Phase I (325) and Phase IV (239). This trend was comparable in both registries. The trend was also comparable for the therapeutic areas in both registries.
India became an attractive destination for clinical trials after regulatory changes, which allowed conduct of global clinical trials conduct in 2005. The availability of a treatment naïve patient pool, large disease burden, experienced and English speaking investigators and relatively low costs led to further growth of this industry. Trials in both registries reflected this with increasing numbers. The fall after 2010 is likely due to the global financial crisis that occurred around 2008. New regulations introduced in 2013 hit the industry hard and this is reflected in clinicaltrials.gov registering the least number of trials in 2015. CTRI on the other hand has shown a steady upswing in numbers since 2014, suggesting that India specific trials (which may not be registered in the USA portal) may have increased. The large number of Phase III trials is a reflection of India’s participation in global trials on drugs primarily discovered outside this country. The small number of Phase I trials is also unfortunate – indicating that not enough original research is occurring in India. New drug development in areas of the country’s health needs is essential. Our results also show that India is not conducting trials in consonance with its health care needs, such as in infectious and parasitic diseases. It is on the other hand encouraging that a large number of Phase I studies are being conducted on vaccines which would help reducing the burden of infectious disease.
We also found a skew in the distribution of trials in the country suggesting that more efforts are needed to spread clinical trials and increase capacity across the country, so as to ensure that there is a more equitable selection of participants and better access to research. We can conclude that India must participate in more clinical trials especially in areas relevant to its disease burden. Policies to encourage new drug development in the areas where it is most needed must be introduced by the government.