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 development. 

Specifically:

• The approval timeline is now 30 working days for indigenous drugs, which will encourage local drug development. For global clinical trials, the review timeline is 90 working days.

• Provisions for accelerated product approval under some conditions, along with the provision of pre-and-post-submission with the CDSCO office, would add predictability and confidence in the system.

• Conditions for local clinical trial waivers for new drugs have been defined to expedite the access of the latest treatments to patients in India. Clinical trial approvals are valid for two years to initiate a study and may be extended for one more year. This would be helpful to initiate the studies quickly and providing faster access to new treatments to Indian patients.

• The new rules aim to ensure patient safety, as they would be enlisted for trials with informed consent. The ethics committee will monitor the trials and decide on the amount of compensation in cases of adverse events 

What are the specific changes in the renewed regulatory pathway that will create a more conducive ecosystem for clinical research and trials in India?

The Rules are comprehensive, well-balanced policy and will improve the ethical and quality standards of clinical trials in the country, which will further benefit patients. The conditions of waiving the local clinical trial requirement under these Rules will help early access to drugs for patients in India. Where the deemed approval for clinical trials in 30 working days for an indigenous drug will speed up the trial process and encourage local drug development.

What does this regulation mean for biotech companies?

These changes have had a significant impact on growth in India. In 2019, the highest number of clinical trial applications were registered since 2013. For Indian biopharma companies who have an ambition of becoming global, there are now specific rules and more of a roadmap to follow to gain the approval of global regulators. 

How is patient centricity changing clinical trials?

For Parexel, patients are at the heart of everything we do. We are focused on engaging and supporting the patients throughout the development cycle by incorporating their input at every stage – pre-study, during the study, and post-study: market access and beyond. Pre-study includes study design – with Patient-Centric Protocol Optimisation (PCPO). We use PCPO to incorporate the needs, views, and experiences of patients and caregivers into trial planning. This helps to create a more patient-friendly study design. This also supports the development of a more practical protocol to ease the patient burden. Throughout the study, we work to reduce the visit burden and promote ongoing trial engagement. Post-study, we work to demonstrate value and support evidence generation and patient access. Our Decentralised Clinical Trial (DCT) offering is also driven by the need to enhance the clinical trial experience to improve patient safety. 

What are the technological innovations which are impacting clinical development? What are the adoption and implementation rates of such technologies? 

It’s a very broad yet interesting topic. However, the most important question in the context of the CRO industry is: are the innovations happening keeping the patients in mind? Also, when it comes to technology innovation, it’s not just about digitalisation – it’s about how digitalisation positively impacts the customer experience. For example, how does the industry use artificial intelligence for predictive analysis? How can the entire lifecycle of study design be reduced through prediction? 

With the COVID-19 health crisis, we have observed how global situations can unexpectedly impact the ability of patients to physically visit a site which is paving the way for the increased consideration of DCT approaches. The key to success in moving to a decentralised approach is prioritising trial standards and consistency to ensure patient safety. Many sponsors have a renewed interest in DCTs as they work to maintain patient safety and data quality and Parexel is working closely with sites and members of our Patient Advisory Council to ensure that we’re keeping both the site and patient input top of mind as we shift a number of traditional trials to the home. 

COVID-19 also has made access to data and the effective use of data in clinical development even more critical as we look to reduce the time to market for new diagnostics and therapies, as well as reduce the burden on patients. Leveraging data enables us to take a more patient-centric and patient-friendly approach in identifying and developing potential cures when compared to randomised controlled trials. Another potential benefit may be the faster and near real-time evaluation of decision-making based on the data that, in turn, will help save lives and result in identifying effective therapies faster.  

Parexel also has a multi-year partnership with Datavant that enables linking of anonymised data across the entire patient journey, including electronic health records, claims and diagnostics, as well as emerging sources such as genomics, wearable devices, socioeconomic and behavioural data and more. Connecting these data sources yields a more holistic view of patient health than clinical trial data alone. By linking real-world data sources with other sources of study data, biopharma customers will be better equipped to generate and submit real-world evidence for regulatory assessment.