The clinical research segment, like many other businesses, is dealing with a complex, new normal as the world struggles to tackle the coronavirus pandemic.
Parexel executives Peyton Howell, chief commercial and strategy officer, and Sanjay Vyas, senior vice-president, India country head and head of Clinical Trial Supplies and Logistics, tell Scrip how the company is working with sponsors to handle the challenges and mitigate disruptions posed by the outbreak.
Many sponsors, they note, are now more inclined to considering decentralized trials as they work to sustain patient safety and data quality. Parexel is also striving to take several aspects of ongoing studies “directly to patients in their homes and in their communities.”
The global clinical research organization (CRO) and biopharmaceutical services company also appears enthused by the prospects for clinical trials in India, after new rules last year provided improved certainty around approval timelines and set out norms for trial waivers. The Indian regulator has more recently also issued a broad notice around managing trials in the context of the coronavirus outbreak. (Also see "COVID-19, Lockdown Affect Trials in India But Coping Efforts In Hand" - Scrip, 31 Mar, 2020.)
Internationally, regulators including the US Food and Drug Administration and the European Medicines Agency have put in place guidance on managing trials during the pandemic. (Also see "US FDA Offers More Advice On Mid-Trial Changes For Pandemic-Impacted Studies" - Pink Sheet, 30 Mar, 2020.) (Also see "EU Urges Sponsors To Assess COVID-19 Impact Before Starting New Trials" - Pink Sheet, 23 Mar, 2020.) (Also see "COVID-19: EMA Tackles Trial Data Interpretability" - Pink Sheet, 26 Mar, 2020.)
Broadly speaking, what is Parexel's overall assessment of the impact of the coronavirus outbreak on CROs – more opportunities after a limited period setback or have trial timelines and potential outcomes been hurt?
Peyton Howell: While much is still unknown at this point, in the short-term we are seeing a temporary slow-down in enrollment of new patients for clinical trials, as investigator sites and hospitals are justifiably prioritizing care over clinical research activities. However, we have actually been able to keep many studies progressing by leveraging remote monitoring, telehealth visits and other aspects of home-based care. Several companies have publicly announced that they are putting enrollment into ongoing trials on hold due to the pandemic, but nearly all of these companies are working to make sure that patients where clinical research is really their only care option are supported as much as possible. At Parexel we are working to minimize 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. 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 a number of fronts to accelerate recruitment and to find new treatments faster.
Sanjay Vyas: Parexel is working closely with sponsors to mitigate the impacts of COVID-19 on clinical research. As an organization, we are bringing as many aspects of ongoing studies directly to patients in their homes and in 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 Decentralized 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 touch points. 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. Our goal is to ensure that as an industry, we are able to maintain our ability to respond and deliver new therapies for patients, even in these most challenging and unprecedented times.
Pre-COVID-19, we saw huge interest in China, which permitted the use of clinical trial data from studies conducted outside the country for regulatory submissions. Parexel last year formed alliances with PKUCare Luzhong Hospital, West China Medical Center, and Shanghai Xuhui Central Hospital ─ providing enhanced support for customers doing Phase I studies in China. How have things progressed and does COVID-19, in some ways, provide opportunities for new studies?
Howell: Parexel now has eight offices, approximately 2,000 employees across all functions in Greater China and more than 8,000 employees in the Asia-Pacific region. Parexel has seen a consistent increase in the number of Phase I studies both in healthy subjects and patients being conducted in China in recent years. While there is great opportunity in the region, many companies struggle with having the local infrastructure required to initiate early phase studies quickly and efficiently, which is critical to success in the long-term.
Through these local partnerships, Parexel is able to provide on-the-ground support for rapid start-up and study execution, complementing our proven early phase clinical pharmacology expertise, along with project and data management and regulatory consulting capabilities with the aim of providing customers with proven strategies for success in China. Parexel is addressing the current COVID-19 situation on a global scale, contributing actively to the vaccine development efforts for COVID-19 while continuing to develop a broad range of therapies with the potential to change and save patient lives.
Our efforts extend beyond our own organization to include collaboration on a harmonized risk-based monitoring approach aligned with regulatory agencies as part of the broader industry response being led through the Association of Clinical Research Organizations. At the heart of everything we do are the patients waiting for new therapies. Our focus during this time remains first and foremost on them and the health and well-being of our 20,000 employees worldwide actively working to deliver on their needs.
Companies like Novartis are using their data analytics platform (Nerve Live) to help improve trial site selection and placement and separately has alliances to blend virtual and traditional trial models, with increasing degrees of decentralization scaling towards a mostly site-less model. (Also see "Six Questions For Novartis CEO Narasimhan" - Scrip, 2 Mar, 2020.) How does Parexel hope to tap into the potential of data analytics, AI in the clinical research segment? Is the acquisition of Model Answers geared in that direction?
Howell: We have significant work and capabilities in leveraging “Big Data” and data analytics at Parexel and it’s a central part of our ongoing investments as part of the ongoing innovation of clinical research. As a result of the COVID-19 crisis, we have seen a renewed enthusiasm to consider decentralized trials or hybrid approaches. This is particularly from a regulatory perspective, where new guidance is coming out swiftly with a number of agencies proactively stating their preference for a DCT [decentralized clinical trial] approach to support patients.
The key to success in moving to a decentralized approach is prioritizing trial standards and consistency to ensure patient safety. Many sponsors are becoming more open to 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.
Parexel has been leveraging data as a critical part of the clinical trial process for some time, through real-world evidence [RWE] studies, decentralized and hybrid trial approaches. Through our partnerships with leading data and analytics companies, we have the ability to access diverse data sets, and to anonymize and link the data to make connections and insights that enhance the clinical development process.
Data can also be used for modeling and simulation in the early stages of development to help reduce risk and increase the likelihood of success by producing a more informed trial design.
Our recent acquisition of Model Answers provides Parexel greater access to the specialized talent and processes necessary for effective modeling and simulation for our customers. The COVID-19 situation 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 during these challenging times. Leveraging data enables us to take a more patient-centric and patient-friendly approach in identifying and developing potential cures, when compared to randomized controlled trials.
Another benefit may be the faster and near real-time evaluation of decision-making based on the data that, in turn, will save lives and result in identifying effective therapies faster.
There’s significant interest around Real World Evidence to support regulatory decisions about product safety and effectiveness of drug therapies. Does Parexel see its alliance with Datavant giving sponsors a distinctive edge in the area?
Howell: The use of Real World Evidence and development and use of synthetic controls arms is a unique strength of Parexel in part because we can also leverage the insights of our industry-leading regulatory consulting team. Across the industry, real world evidence is becoming an essential component to evaluating the safety and effectiveness of drug therapies and ultimately to delivering therapeutic advances. However, one of the most significant barriers to generating real-world evidence is overcoming limitations of single data sources. Our partnership with Datavant is providing Parexel the ability to link disparate data sets to drive the complex analyses necessary for providing innovative scientific and clinical data strategies.
Some experts expect to see outcomes-based pricing in the CRO space, with a potential upside when outcomes are delivered early. Does Parexel already have something on those lines in place?
Howell: For Parexel, our priority is always on delivering for our customers and putting the patient at the heart of everything we do. While we don’t discuss specific commercial terms and approaches, our goal is always to be flexible and aligning with our sponsors to meet their needs in order to get the treatments faster to the market to benefit patients. The focus we see is on performance-based alignment to support transparency and accelerate drug development.
In general, have the Indian New Drugs and Clinical Trials Rules, 2019 increased sponsor interest in India, now that the regulations provide more certainty around approval timelines and clarity around compensation issues?
Vyas: 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 the result of the New Drugs and Clinical Trials Rules. This has been an important change for the drug development industry in India and for patients in need. Obviously, it’s very early to predict, but we are very hopeful based on the increased sponsor interest in clinical research in India will result in significant new growth and opportunities for our team in India.
Do provisions in the Indian rules that permit a Phase III trial waiver for new drugs approved and marketed in specific countries, subject to conditions, represent a significant boost for both patient access and sponsors?
Vyas: We are very supportive of these advances. Previously, it was a regulatory requirement that sponsors conduct Phase III studies in India in order to receive regulatory approval in India. However, due to the recent waiver per the New Drug and Clinical Trial Rules, it is not required that a Phase III study be conducted in India. This will allow sponsors to launch their products faster with more predictable timelines in India and thereby expedite access of latest treatments to the Indian population.
Are there still sponsor concerns about placing studies in India given the past shadow of compliance issues that came up at some Indian CROs or is that well in the past now?
Vyas: Our industry remains committed to research quality and patient well-being. Regulatory scrutiny overall has been higher in India and sponsors routinely require audits. Given the importance of patient safety, these are all reasonable and welcome changes that are critical to advancing our industry and making new therapies available to the patients who need them.