Part 1: ‘Learnings from China: Managing in the time of pandemic’

An unprecedented crisis

The coronavirus struck China in January like an avalanche – an abrupt and intractable threat that prompted Chinese authorities to impose a total lockdown in Wuhan to stop the virus’ spread.  Soon after, travel restrictions were put in place across China.

For sponsors and CROs, the crisis was unprecedented: How could they protect the safety of trial participants (and their own employees) while also continuing the vital task of collecting trial data? 

Patient safety is #1.  Everything else is secondary

For our teams at Parexel, the answer was to prioritize, analyze, collaborate, and act to move trials forward, putting patient safety first. The task was monumental and required nimble, adaptive solutions to orchestrate hundreds of sponsor trials involving tens of thousands of patients. In collaboration with our sponsors and regulators, we quickly adapted our normal procedures to fit new rules and overcome obstacles to ensure patients received investigational drugs without interruption.

Prioritize, analyze, collaborate, act, repeat

We began with a detailed review of all our trials in China to prioritize patients at greatest risk because of the travel restrictions – oncology trials, for example. How could critically important investigational medical products (IMPs) be delivered to patients when they were prohibited from traveling to investigator sites?  How much IMP stock did each site have on hand?  Which IMPs required temperature control during transport and storage?  What was the situation on the ground at each hospital/investigator site?  Trial by trial, site by site, we answered these and other critical questions.

Using this information, we coordinated with sponsors, investigators, regulatory authorities and other stakeholders to develop action plans.  Collaboration has been key.  We consulted each stakeholder to obtain their input and buy-in before pursuing a course of action.  This helped us circumvent barriers and created an environment of trust – a much-needed commodity in times of crisis.  Every step of the way, the global Parexel coronavirus task force communicated lessons learned in China to our colleagues around the world to pre-empt challenges and minimize trial interruptions.

We prioritized critical operations and essential outputs to ensure patient safety and business continuity, including:

• Patient/employee care
• Drug/IMP supply
• Patient enrolment/retention
• Monitoring
• Data integrity
• Regulatory

A Holistic Approach to Patient Care

As the crisis deepened, patient anxiety emerged as a widespread concern that could have jeopardized trial retention. If patients didn’t feel safe and secure, they were unlikely to continue in the trial.  We worked with sites and investigator staff to answer patient questions about the risks associated with visiting a site/hospital, how to mitigate those risks, and the critical role of trial participation in the development of new therapies.  We provided sites with masks to give to patients, and sites explained best practice for lowering risk of infection.  Reducing patient fear and anxiety through information and support has been a key lesson learned.

Leave no stone unturned in collecting data in new ways

After patient care, our next highest priority was to keep trials in motion: collecting data as much as possible, documenting protocol deviation, and maintaining data integrity.  We worked with sponsors and regulators to adapt to the new rules and navigate restrictions that varied by region. One of our first actions was to evaluate almost 300 sites, mostly hospitals, to determine their availability for patient monitoring and visits. Because many of our trials involved the same sites, this strategy allowed us to quickly determine the impact of “no travel, no-go zones” by site and adjust accordingly.  Among our many solutions, we

• Contracted with specialized, safety-accredited taxi services to transport patients to hospitals that allowed subject visits.
• Sent patients to local labs for testing when a central lab was inaccessible
• Scheduled virtual and remote visits to replace site visits
• Rescheduled essential visits to later dates

One of our biggest successes was delivering drugs/IMPs to patients’ homes.  Within two weeks' time, we identified qualified delivery vendors, instituted vendor training, and orchestrated a delivery platform that ensured patient confidentiality.

Key Lessons Learned

By employing creative strategies, our preliminary analysis indicates that we successfully reduced the incidence of missing data during the most critical period between late January to mid-March.  Key lessons learned were to leave no stone unturned in collecting data in new ways; to proactively discuss the potential protocol deviation and protocol amendment as needed; and to carefully document how the data were collected so that it can be evaluated and considered for analyses after data-base lock.

Another success and lesson learned was the use of remote monitoring techniques that we previously had applied primarily to observational studies.  In early March, after working with sponsors and regulatory authorities, we began to use remote monitoring for some interventional studies.

This article touches the highlights of our COVID-19 experience in China.  As the travel restrictions have been lifted and things return to a more familiar state, we are communicating our learnings to Parexel staff around the world and to our esteemed clients.

The next article in this series will be about the return to “the new normal”’ and what biopharma companies and CROs should be doing now to quickly adapt to a new but forever altered clinical trial landscape.

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