Parexel has deployed at-home care and monitoring as well as delivered supplies and drug products Direct-to-Patient to minimise the impact of the Covid-19 pandemic on ongoing clinical trials, says Sanjay Vyas, Parexel’s Senior Vice President, India Country Head & Head of Clinical Trial Supplies and Logistics (CTS&L). In an email interaction with Viveka Roychowdhury, he also analyses India’s revised New Drugs and Clinical Trials Rules 2019 and the moves to create a more patient-friendly study design, on the eve of Clinical Trials Day, celebrated on May 20 every year.
How are CROs like Parexel handling the disruptions in clinical trials caused by the COVID-19 pandemic?
Overall, our industry has responded and is meeting the challenge. Times of great challenge can also lead to innovation, and Parexel is working with our customers and partners on several fronts to accelerate recruitment and to find new treatments faster. At Parexel we are working to minimise the impact of the pandemic on current studies as much as possible while at the same time starting a wide range of new work specific to COVID-19. As an organisation, we are bringing as many aspects of ongoing studies directly to patients in their homes and their communities. For example, we are leveraging direct-to-patient shipments of supplies and drug products via our in-house clinical trials supplies and logistics services. We are working with clients to deploy at-home care and monitoring via our Decentralised Clinical Trials service. We are leveraging remote source data verification and expanding our data-driven monitoring partnership. Our Patient Innovation Center has been at the forefront keeping patients engaged and motivated through regular touchpoints.
During this time, we are also supporting customers and investigator sites who are navigating a new and evolving regulatory and financial landscape and working with clients to develop business continuity strategies. With more than 1,000 on-staff consultants worldwide, including 80+ former regulators and inspectors who have extensive knowledge of and expertise with the GxP, CMC and cGMP review and inspections, Parexel is well-equipped to support life sciences manufacturers in safely ensuring business continuity.
According to reports, India does less than 1.2 per cent of global clinical trials even though the country has the second largest population in the world and some of the highest disease burdens for certain conditions. What has led to this discrepancy and how can this be rectified?
The drug development landscape in India has certainly evolved in recent years through a period where clinical trials were nearly shut down or actively disengaged followed by a period of uncertainty about conducting trials with limited government guidance. Today, we have a fairly articulate system of guidelines forcing good governance and strong compliance as a result of the New Drugs and Clinical Trials Rules 2019. This has been an important change for the drug development industry in India and patients in need.
What has been the impact of India’s revised New Drugs and Clinical Trials Rules 2019 notified by the Ministry of Health & Family Welfare in March 2019, on the number of clinical trials being conducted in India?
It’s very early to predict, but we believe sponsors will see the benefits of conducting clinical research in India. In 2019, the highest number of clinical trial applications were registered since 2013. With the new rules for clinical trials being announced in 2019, we believe we will begin to see faster approvals of new drugs as a result of the waive of the requirement of local clinical trials for drugs that have already been approved in other countries, which will help expedite access of latest medications to the Indian population.
What are the measures that have been taken to make the trial approval process faster and more transparent?
Overall, the new rules that have been established are comprehensive, well-balanced and will likely improve the ethical and quality standards of clinical trials in the country, which also will further benefit patients and industry. The rules are intended to revive the clinical research industry in India, bringing more global clinical studies to India and promoting Indian indigenous drug...
(All Rights Reserved)