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The wind of change is blowing over the global clinical trial landscape and India is placed rather well to take on the research work being done by the biopharmaceutical industry.
Recently, the United States Food and Drug Administration (USFDA) outlined efforts proposed to modernise the conduct and design of clinical trials, to make them more agile without compromising data integrity or participant protection, the regulatory agency said, about the on-going efforts.
Months before that, the United Kingdom’s regulator, MHRA (Medicines and Healthcare products Regulatory Agency) said it would streamline clinical trial approvals in the biggest overhaul of trial regulation in 20 years. These legislative changes would help make UK one of the best countries in the world to conduct clinical research for patients and researchers, it added.
Closer home, industry-watchers observe that India stacks-up well against its counterparts, as drugmakers get back on the rails with their research pipelines, and as the dedicated focus on Covid-19 products eases.
Sujay Shetty, Partner and Global health leader with PwC, points out that India has made advances in healthcare infrastructure, regulatory governance of clinical trials and the number of trial investigators for example, a long way from the state of this industry in 2014.
Regulatory reforms post 2013 and the New Drugs and Clinical Trial Rules of 2019 have streamlined approval processes, reduced timelines by 30-40 per cent, and introduced several exemptions and provisions to improve the overall efficiency of conducting clinical trials, a recent PwC study, pointed out.
Outlining key drivers of change in the global clinical trials industry, Sujay says, the impact of the Russia-Ukraine war is being felt by the industry, as some trials saw patient recruitment being halted; and the USFDA is pushing for greater diversity in the population represented in the trials presented to it.
In fact, the PwC study quotes Peter Ronco, Head of Global Development, Janssen R&D (J&J) saying, “We had about 60 to 70 studies running in Ukraine at the point of the invasion and so we are now looking as a company about how we move that book of work elsewhere around the world.”
The study also quotes Peyton Howell, Chief Operating and Growth Officer, Parexel, saying, “We are mitigating the risk (Russia-Ukraine situation). We do think it opens the door in terms of opportunities for India.”
Work in progress
However, not all challenges have been ironed out in India.
It is important for trial sponsors to work with quality contract research organisations (CRO) in India, located largely in the top cities of the country, says Sujay. The challenges that still need to be addressed include increasing awareness on clinical trials, ensuring more quality trial sites, and to encourage more volunteers to participate in trials that help bring out better drugs for patients.
Globally, India accounts for about four percent of global trials and three percent of trial participants. This needs to improve, say industry representatives, given the large disease burden in the country. But, with strong safety-catches in place to protect patients volunteering for these trials.
“Everyone needs to play their part,” says Sanjay Vyas, Executive Vice President and Managing Director, Parexel (India), on the role of multiple stakeholders (hospitals, investigators, sponsors, pharmaco-vigilance committees, etc) in adopting the best practices and protecting the patient.
#Nolookingback
The pandemic had seen global systems work on a war-footing to get drugs, vaccines and other medical products to patients. There were faster approvals and flexibilities in the system, including the use of technology and remote systems to get trial medicines to patients and monitor them, recalls Vyas, and this eco-system should not lose steam.
Pointing to a trending campaign during the pandemic, he says, there indeed should be “#NoLooking Back”. India is on the list of top-sites for drugmakers looking to undertake global trials and this is an opportunity, he said, as it paves the way for faster patient access to these therapies.
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