The impact of COVID-19 on R&D in life sciences

The effects of the pandemic on the life sciences industry have been profound and far-reaching.

Introduction

The urgency to understand the coronavirus, identify effective treatments, and develop robust vaccines has galvanized and mobilized the global scientific community in a way that’s unprecedented in modern history. There’ve been unparalleled levels of collaboration between industry, academia, government, and regulatory bodies with innovative approaches in clinical trial design, data collection and analysis, and regulatory strategies. A recent report from McKinsey1 provides a comprehensive overview of the impact of the COVID-19 pandemic on research and development activities within life sciences and the potential industry response. Many macro-level trends have been accelerated due to the pandemic—such as the use of digital telehealth technologies, innovative clinical trial designs that are adaptive and more inclusive, or the use of cloud-based systems for data capture. Other trends have highlighted structural barriers that still need to be addressed. These include the need for accelerating the collection of clinical trial data through trial software integration with electronic medical records (EMR), as well as the need for greater interoperability—like the ability for healthcare technology systems and devices to exchange, interpret, and store data using common standards. A key unknown that remains, however, is which of these advances will stick after an effective vaccine is found and the immediate crisis has passed. Some genies will be difficult to put back into the bottle, like the advance of digital health technologies, and the convenience of telehealth approaches for patients. Others may fade, as the benefits of altruistic collaboration are replaced by the desire to re-establish avenues for competitive advantage and differentiation, for example the use of master clinical trial protocols for vaccine development. A recent editorial in Nature Reviews Drug Discovery2 also serves as a call to action for how COVID-19 should catalyze change in other areas of clinical development to better serve all patients.

Many macro-level trends have been accelerated due to the pandemic— such as the use of digital telehealth technologies, innovative clinical trial designs that are adaptive and more inclusive, or the use of cloud-based systems for data capture.

Of the many topics covered in the McKinsey report, two of the key areas of disruption due to COVID-19 are highlighted below

COVID-19 impact on clinical trial operations

There’s been severe disruption to clinical trial operations as a result of COVID-19. By May 2020, more than 50% of companies had paused recruitment for the majority of trials, and 75% had paused site activation for the majority of trials1 . In those ongoing trials, disruption caused by COVID-19 has driven an extraordinary number of deviations in clinical trial operations— such as missed patient visits and lower new enrollment—raising questions about data and broader trial integrity. Most companies have moved swiftly in revising core components of their trial policies, for instance by delaying new trial starts or pausing new enrollment, and they’ve actively triaged the feasibility of keeping only those trials deemed essential up and running1 . For trials that are continuing, clinical leaders have begun focusing on operational agility through a host of digital and “quick-win” tools that reduce patient and site burden. These include remote patient engagement—and, where possible, the ability to assess endpoints virtually—plus in-home nurse visits, shipping investigational medicinal products directly to patients with appropriate support, and conducting site-level outreach to ensure monitoring. In addition, one area highlighted by McKinsey for companies to consider as a longer-term response to the current crisis is to create greater resilience in sourcing models. The debate between efficiency and resilience will be paramount as companies think about R&D—for example, rebalancing research work by contract research organizations (CROs) across countries, or reevaluating clinical supply chain diversification to minimize vulnerabilities, even if it comes at a greater cost1 .

COVID-19 impact on regulatory considerations and approaches.

Within the U.S., the FDA has granted numerous Emergency Use Authorizations (EUAs) to allow unapproved drugs and devices to be used to treat or manage COVID-19 and its clinical consequences3. EUAs are granted when there’s some evidence to suggest a device or drug might be useful to treat COVID-19—but that level of evidence hasn’t yet met the FDA’s usual thresholds for a full approval4. This means the drug or medical device company has permission to market their product within strict guidelines, like only to COVID-19 patients who’ve met certain criteria. This is important because it allows companies to start to generate real-world evidence with their products that could potentially be used in the future to support conversion of the approval from an EUA to full regulatory approval, in addition to generating sales revenue. There’s gradually increasing acceptance of using such data to support regulatory filings as the FDA starts to take a more pragmatic approach that goes beyond the stringent requirements for double-blind, randomized controlled studies, the current gold standard. It will be a strategic priority for any company who has obtained a EUA for their product or device within the U.S. to seek to convert that to a full approval, and retain access to the hugely profitable U.S. market segment.

Key questions to consider:

• With your current clinical pipeline, have you been forced to put things on hold during COVID?
• Have these changes forced you to see a noticeable increase in deviations? How has your current team been able to support those deviations or data integrity? Do you have enough clinical data coordinators or quality teams in place to deal with these deviations?
• When you resume your trials, how will the current climate change how you staff for trials, or the number of support staff you need to manage them more remotely or virtually?
• Are you concerned by the risk of potential delays to your filing?
• As you consider your overall CRO strategy, are you considering cost effective opportunities for site diversification?
• Do you have a perspective on the value of using real-world evidence to supplement your clinical data and regulatory filings? Have you explored diverse and adaptive clinical trial designs to accelerate your clinical trial operations?

Sources:

COVID-19 implications for life sciences R&D: Recovery and the next normal, Agrawal et al, published May 2020

https://www.nature.com/articles/d41573-020- 00149-2, published Sep 2020

https://www.fda.gov/emergency-preparednessand-response/mcm-legal-regulatoryand-policy-framework/emergency-useauthorization#covid19euas

https://www.fda.gov/medical-devices/ coronavirus-disease-2019-covid-19-emergencyuse-authorizations-medical-devices/faqsemergency-use-authorizations-euas-medicaldevices-during-covid-19-pandemic