COVID-19 Q&A: Impacts of the pandemic on R&D

April 23, 2020

HRI spoke with PwC partner Anup Kharode and director Brian Slizgi about how pharmaceutical and life sciences R&D teams are dealing with COVID-19 and considerations they should make as the virus abates and restrictions are lifted.

PwC Health Research Institute (HRI):

We’re seeing reports that medical centers are closing to in-person visits, including those associated with clinical trials. What are you hearing in terms of how R&D is being affected by the outbreak?

Anup Kharode, PwC Partner:

There’s certainly a heightened focus on patient safety and data integrity, especially for trials that are further along in the study life cycle, where a significant amount of data has been collected.

For those studies around life-threatening diseases, there are significant efforts being made around sites to ensure patient health is being protected. Other areas of focus are monitoring the progression of the pandemic to understand what the implications are for sites going forward in terms of when subjects can be reenrolled and when sites can be reactivated.

Companies are planning for those activities to get trials back in motion. We’re hearing this same theme across sponsors. There will be a tremendous burden placed on study startup groups at sponsors and contract research organizations (CROs) as stay-at-home orders are lifted.

HRI: What are the surprises or unanticipated trends?

Anup Kharode: The disruption of the portfolio in terms of how companies quickly shifted gears to focus on treatments or vaccines related to the virus given the regulatory environment to accelerate treatment availability, the CARES Act funding for vaccines and treatment related to coronavirus itself. There has been this laser focus on trying to examine existing pipelines or existing products for treatments.

There’s certainly a heightened focus on patient safety and data integrity, especially for trials that are further along in the study life cycle, where a significant amount of data has been collected.

HRIWhat are you seeing around the movement to virtual trials, particularly with the FDA’s guidance around remote monitoring?

Brian Slizgi, PwC Director:

We’ve not seen a shift to virtual trials across the board. There had been a lot of philosophical discussion before the COVID pandemic about virtual trials with a small proportion truly virtualizing, many with the support of vendors.

One of the biggest challenges had been virtualizing many of the more serious therapeutic areas and the cascade effect on trial designs. I think we’ll see a significant acceleration of innovative clinical trial methods, including virtual trials, once this quarantine is lifted.

Remote monitoring is seeing an interesting shift as a result of COVID. Historically the industry has adapted to a reduced source data verification [SDV] and risk-based monitoring [RBM] approach.

What is interesting is how rapid the innovation has accelerated in this space. Almost immediately after the quarantine was put into effect, many investigators were able to grant remote electronic health records (EHR) access for sponsors and their CRO partners to conduct remote source data verification.

I suspect this innovation far beyond the boundaries of traditional monitoring and reduced SDV will likely carry forward into the post-COVID drug development environment and provide a pathway for improved data quality and patient safety balanced with responsible economics.

Anup Kharode: This has been a lightning rod for companies to understand the value of trial virtualization. In the cases where remote data collection was possible and being implemented, companies are reaping the benefits.

Also, companies that have invested heavily in digital therapeutics are now really pleased that they got a head start on this front to virtually engage patients, collect insights and understand how patients are responding to therapies, aligned with ongoing wellness efforts.

HRI: With remote monitoring and virtualized models, does that also expand patient access to clinical trials?

Brian Slizgi: Clinical trial access has been a significant issue in drug development. Sponsors routinely partner with the same investigators in order to enroll patients in their studies, and as a result, we’ve seen significant access challenges.

This topic has become a significant point of investment and dialogue among sponsors over the past few years, but we’ve not seen any significant uptick in clinical trial diversity. I do believe that remote and virtualized trials conduct methods are likely to drive a significant improvement in access as we as an industry will “bring trials to the patient or subject.”

Simply put, underserved populations will have access to leading investigators and treatments at the forefront of drug development.

Anup Kharode: Another thing that the pandemic could accelerate is the leveraging of EHR data and the integration of these insights as new therapies are developed and new patient populations are studied. Given the speed at which some organizations have set in motion COVID-19 trials, using EHRs will be critical to understanding patient populations, demographics, and preexisting conditions to understand responsiveness, efficacy and safety.

HRI: How can companies prepare for when the physical distancing is lifted? What are you expecting?

Brian Slizgi: A lot of companies have not been thinking about that yet. Once you’ve fought the fire, how can you rebuild it?

Anup Kharode: Decisions about critical studies and the progression of the pandemic and the staggered means by which the stay-at-home orders are going to be lifted could be informed through predictive models. These will inform tough decisions about halting studies, issuing protocol amendments or perhaps activating more sites than they had imagined.

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Anup Kharode

Partner, Pharmaceutical and Life Sciences, R&D Advisory Services Leader, PwC US

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