Mitigating impacts of a global pandemic in the clinical development space
The evolving public health emergency is forcing scientists to develop COVID-19 vaccines on an unprecedented timeline, and many developers are moving at a pace that has never been seen before. The current pandemic experience is transforming and shaping the way we conduct clinical trials. In this post, David M. Johnston, Ph.D., executive vice president, global clinical development, shares how the clinical development team at PPD has successfully navigated the COVID-19 pandemic.
As with so many of us, the plans and initiatives PPD had on deck for 2020 changed drastically only a few months into the year as COVID-19 took the globe by storm. Investigator sites were closed, some studies were delayed and there were a number of regulatory changes. At PPD, priorities shifted as we looked for ways to overcome challenges created by the pandemic so that we could continue to support our clients’ projects, ensure trials progressed safely for the patients involved and generate evidence desperately needed to improve the health of people around the world. And over the course of just a few months, we’ve worked together as one PPD to mitigate these, and other, impacts.
Study modifications due to COVID-19
Nearly all studies managed at PPD required some sort of modification as a result of COVID-19. A team was quickly formed to coordinate study impact mitigations and plan for recovery as restrictions are lifted. This team aided in revising forecasting on a country-by-country basis to generate modified plans.
For studies that were impacted by sites being closed, we worked with the study sponsor teams to change to telemedicine virtual visits where possible and used some combination of our decentralized solutions. We also worked with partners to deliver study investigational product (IP) directly to patients for dosing at home, either by the patient or via a home health nurse. In some cases, we were able to convert patients from traditional sites to metasites in close proximity to the original site.
For investigator sites that were still open but not allowing visits from clinical research associates (CRAs), our study teams worked to reschedule visits or convert on-site visits to remote monitoring visits. We also have explored ways to perform remote site activation, and, in some cases where allowable, remote document review and verification. We increased the use of data analytics and centralized monitoring to help us manage active studies and identify issues.
Additionally, our teams developed planned deviations to support ongoing projects, carefully documenting any changes to protocol to protect the study data, following rapidly changing regulatory guidance.
For COVID-19 vaccine and therapeutic clinical studies, PPD has achieved startup in very short timelines by using innovative approaches. PPD began its innovation and virtualization journey well before the pandemic, enabling us to embrace and execute a wide variety of solutions. We combine our extensive therapeutic and laboratory expertise with our vast global resources to offer a distinctive caliber of vaccine development services and accelerate development with proven capabilities and dedicated resources. During this pandemic, we have broken many of our own records for speed, including multiple cases where we went from clinical trial agreement to patient dosing in under 24 hours for specific sites.
As we move forward, our focus is shifting more to recovery. Our teams have worked together to develop a tool for reforecasting studies, taking into account COVID-19 impacts due to country restrictions. This tool, called Preact, allows teams to visualize the impact on enrollment milestones and uses machine learning and augmented intelligence from user inputs with real-time study actuals to generate simulations that predict enrollment.
Even though we are still in the midst of the global pandemic, we’ve already started to evaluate and catalog what we did right and what could be improved in preparation for a potential second wave of this pandemic and for any future broad study disruption.