Part 2: ‘Learnings from China: Managing in the time of pandemic’

The upcoming ‘new normal’

“The COVID-19 outbreak began in Asia – but so have early indications of containment, new protocols, and the resumption of economic activity. … [I]t’s time to ask if the next normal could be emerging in Asia.” – McKinsey & Company, April 2020

With China having lifted travel restrictions and other countries hoping to do so in coming weeks, CROs and biopharma companies should be readying themselves to quickly adapt to the “new normal” based on learnings from the first stage of the crisis, which is focused on patient/employee safety and business continuity.

The challenges of COVID-19 on clinical research were covered in our first blog of our series: including suspended trials; challenges in recruiting and retaining patients; difficulties in getting investigational therapies to patients; and complications in collecting data, to name a few.

In this article we’ll examine the next stage of how we see COVID-19 playing out and the return to a familiar – but also a changed and changing – clinical trial ecosystem. 

One thing to keep top-of-mind: There will never be a better time to implement near-term changes based on learnings from this crisis.  In China we’re seeing investigators and sites much more open to innovations such as remote monitoring; patients have benefited from direct-to-patient delivery of study medications; and collaboration between sponsors, CROs, and regulators has shortened actions that normally take months into days or weeks.

The world is now looking to the biopharma industry to bring the hope of new treatments for COVID-19 and the most desired outcome of all – a vaccine.

This presents a golden opportunity to keep the momentum going. Crisis-born innovations that have shown their worth should be institutionalized as soon as possible.  Task forces and workflows should be coordinated centrally to ensure that country, regional and global changes align.

The new normal: Less patient travel, less anxiety, higher retention

We believe transition to the new normal will include greater use virtual trials and digitally enabled remote activities.  This will be especially important as sponsors try to recruit patients who may be reluctant to visit sites and hospitals because of fear of contracting COVID-19 or other communicable diseases.

In China and South Korea, we implemented the following to keep trials moving forward during February and March, when travel restrictions made traditional means unavailable.

• Remote source data checks.  We instructed sites to send select anonymized source documents for checking.  We believe this could be part of the new normal, dependent on local regulations with appropriate oversight and controls. At a minimum it should be incorporated as part of risk-mitigation plans.
• Remote monitoring visits.  We used a structured approach to cover monitoring processes and items normally done onsite. Thorough guidance was provided to the clinical research associates ensure focus on critical data and safety-related points.

Interest in decentralized clinical trials (DCTs) is rising.  The Chinese government recently issued a plan of action to promote virtual clinical trials to both speed development and reduce face-to-face interactions required in traditional trials.

We will go into DCTs in more depth in part three of the four-part series.

The key learnings for biopharma and CROs are two-fold:  First, companies should prioritize, accelerate, and scale the rollout of digital tools to online clinical trials.  Second, companies should collaborate broadly with regulatory authorities and other stakeholders to establish online trial management platforms, such as ethics committee review, patient consent, trial monitoring, etc.

The sense of urgency created by COVID-19 has created opportunities to accelerate the adoption of innovations to make clinical research faster and more resilient and reduce the burden on patients.  These include:

• eConsent: Implement an online consenting process.
• eSource systems: Maximize the use of systems where data is captured by the investigator when the patient is present, thus minimizing the need for source data verification (SDV).
• Access to electronic medical records (EMR): Dramatically improve efficiency and reduce the need for site visits with EMRs, using proper systems and controls to ensure patient confidentiality and the security of EMR data, this would dramatically improve efficiency and the need for site visits.
• Video calls: Host video meetings between CRAs and sites state for virtual site monitoring visits.
• Remote drug accountability: Move from paper-based drug accountability logs, the current norm, to web-based systems to ensure drug accountability across the trial lifecycle.
• Travel assistance: Provide patients with trained, accredited transportation services to shuttle them to and from sites.
• Patient education materials: Provide sites and investigators with informational materials to give to patients about risk reduction measures during a site visit.  This aids recruitment and retention.

Another way to reduce patients’ travel burden and the number of people they meet in person is home nursing, in which nurses conduct clinical study visits in the patients’ homes.  Home nurses also can coordinate integrated ancillary services, such as patient travel support, direct-to-patient investigational medical product shipment, and sample transportation.

Direct-to-patient drug shipments present another opportunity for change. We used this strategy to overcome barriers to patient travel during the crisis.  Currently we have 250+ actives DTP studies globally, not including the studies in China in which DTP was used on an emergency basis.

While we are still evolving and adjusting to the new normal, we hope this blog gives you a flavor for how COVID-19 has created many opportunities to change our industry for the better.

To learn more about our lessons learned in China with COVID-19, register for our webinar on April 23.