S. Harachand, Contributing Writer05.02.22
Participation of contract research organizations (CROs) in India for global clinical trials has been on a steady uptick, of late, due to the COVID-19 pandemic and the improving regulatory climate.
What is more surprising is India clocked the highest tally in the recent years in terms of global clinical trial approvals in 2021, a year that witnessed the country battling with its most devastating wave of the pandemic.
Of course, the CRO sector did take a hit registering a decline in numbers the previous year when companies the world over began massively cutting back on recruiting patients due to shutdowns of all civic activities as a measure to tame SARS-CoV-2 infections. More than 2,000 trials registered on ClinicalTrials.gov were terminated owing to the challenges of doing clinical research during the pandemic.
Notwithstanding the small drop, the trial approval numbers continued to remain close to that of the preceding year reflecting the upward trend that started at least a couple of years back.
Clearly, the pandemic plays a lead role in the growth story. Estimates show that studies on therapeutics and vaccines against the pandemic virus account for as much as 15 percent of the ongoing clinical trials in India.
Experts are of the view that the past two years have turned out to be transformational as this period put the clinical research industry on a learning curve. It has encountered how to bring in better adoption of technology and, at the same time, how to ensure patient continuity and patient safety.
Big Pharma too endorses that India is again high on their radar as a destination to run global clinical trials.
Meanwhile, many leading CROs and clinical trial experts hold that India's recent overhaul of the clinical trials regulations plays crucial in pushing the figures upward.
India revamped its rulebook governing clinical research in 2019 removing certain contentious clauses with an aim to foster a regulatory environment conducive to the growth of the sector.
Extremely low costs have always been a major attraction that brings global firms to Indian shores to conduct clinical trials. However, often this cost advantage is subsumed by long-hauled regulatory approval timings.
The new set of rules mandate predictable timelines for the approval process while bringing more clarity into certain clauses pertaining to paying compensation for trial victims, which many CROs found highly ambiguous.
On earlier occasions, clinical trials in India drew a lot of flak after a series of scandals involving allegations of unethical practices and bad press saying the trial participants were being treated like “guinea pigs” without proper informed consent.
Therefore, ensuring the rights, safety and welfare of participants is one of the key focuses of the new regulations. In addition, efforts are made to make sure that SOPs and data generation are in line with globally accepted practices.
Even as these more cohesive and comprehensive rules lay the roadmap for how all clinical research should proceed, CROs contend that the quality of clinical research is going to grow.
As it is, globally recognized processes, quality standards and operating models mandated by the New Drugs and Clinical Trials (NDCT) 2019 have naturally pushed up costs making trials in India a bit more expensive. The cost advantage, however, does not seem to fade. Conducting a clinical trial at an Indian site is still far less costly than other leading destinations.
Aside from the cost advantage, an enormous and a genetically diverse base of treatment-naive population makes India an important location for conducting clinical trials.
India's nearly $2 billion clinical trials market is expected to reach $3.15 billion, growing at a faster clip in the next three years, according to some estimates.
Notably, India hosts only 1.2% of the world’s clinical trials at present despite having a high burden of disease.
Another key factor that makes India more compelling for global CROs is its rich talent pool. There are few places in the world where one can access a large volume of skilled professionals on a regular basis like India. The cost of maintaining a site in India remains way below that of the U.S. or EU.
A large reserve of talents with over 10 years of experience is another attraction that motivates outsourcing companies.
AstraZeneca India underscored this point while launching a clinical data and insights (CDI) division in India last October for the management of data-related aspects of its clinical trials. The CDI team works across therapy areas and portfolios, supporting early and late-stage clinical programs from phase 1 to phase 3 with an integrated end-to-end approach for clinical data, analytics, insights and risk management.
S. Harachand
Contributing Editor
S. Harachand is a pharmaceutical journalist based in Mumbai. He can be reached at harachand@gmail.com.
What is more surprising is India clocked the highest tally in the recent years in terms of global clinical trial approvals in 2021, a year that witnessed the country battling with its most devastating wave of the pandemic.
Of course, the CRO sector did take a hit registering a decline in numbers the previous year when companies the world over began massively cutting back on recruiting patients due to shutdowns of all civic activities as a measure to tame SARS-CoV-2 infections. More than 2,000 trials registered on ClinicalTrials.gov were terminated owing to the challenges of doing clinical research during the pandemic.
Notwithstanding the small drop, the trial approval numbers continued to remain close to that of the preceding year reflecting the upward trend that started at least a couple of years back.
Clearly, the pandemic plays a lead role in the growth story. Estimates show that studies on therapeutics and vaccines against the pandemic virus account for as much as 15 percent of the ongoing clinical trials in India.
Experts are of the view that the past two years have turned out to be transformational as this period put the clinical research industry on a learning curve. It has encountered how to bring in better adoption of technology and, at the same time, how to ensure patient continuity and patient safety.
Big Pharma too endorses that India is again high on their radar as a destination to run global clinical trials.
Meanwhile, many leading CROs and clinical trial experts hold that India's recent overhaul of the clinical trials regulations plays crucial in pushing the figures upward.
India revamped its rulebook governing clinical research in 2019 removing certain contentious clauses with an aim to foster a regulatory environment conducive to the growth of the sector.
Extremely low costs have always been a major attraction that brings global firms to Indian shores to conduct clinical trials. However, often this cost advantage is subsumed by long-hauled regulatory approval timings.
The new set of rules mandate predictable timelines for the approval process while bringing more clarity into certain clauses pertaining to paying compensation for trial victims, which many CROs found highly ambiguous.
On earlier occasions, clinical trials in India drew a lot of flak after a series of scandals involving allegations of unethical practices and bad press saying the trial participants were being treated like “guinea pigs” without proper informed consent.
Therefore, ensuring the rights, safety and welfare of participants is one of the key focuses of the new regulations. In addition, efforts are made to make sure that SOPs and data generation are in line with globally accepted practices.
Even as these more cohesive and comprehensive rules lay the roadmap for how all clinical research should proceed, CROs contend that the quality of clinical research is going to grow.
As it is, globally recognized processes, quality standards and operating models mandated by the New Drugs and Clinical Trials (NDCT) 2019 have naturally pushed up costs making trials in India a bit more expensive. The cost advantage, however, does not seem to fade. Conducting a clinical trial at an Indian site is still far less costly than other leading destinations.
Aside from the cost advantage, an enormous and a genetically diverse base of treatment-naive population makes India an important location for conducting clinical trials.
India's nearly $2 billion clinical trials market is expected to reach $3.15 billion, growing at a faster clip in the next three years, according to some estimates.
Notably, India hosts only 1.2% of the world’s clinical trials at present despite having a high burden of disease.
Another key factor that makes India more compelling for global CROs is its rich talent pool. There are few places in the world where one can access a large volume of skilled professionals on a regular basis like India. The cost of maintaining a site in India remains way below that of the U.S. or EU.
A large reserve of talents with over 10 years of experience is another attraction that motivates outsourcing companies.
AstraZeneca India underscored this point while launching a clinical data and insights (CDI) division in India last October for the management of data-related aspects of its clinical trials. The CDI team works across therapy areas and portfolios, supporting early and late-stage clinical programs from phase 1 to phase 3 with an integrated end-to-end approach for clinical data, analytics, insights and risk management.
S. Harachand
Contributing Editor
S. Harachand is a pharmaceutical journalist based in Mumbai. He can be reached at harachand@gmail.com.
