As the biomedical sector rapidly mobilizes to address the novel coronavirus pandemic, we are encouraged to see the strong embrace of collaboration, master protocols and platform studies, all in the spirit of delivering the most useful information in the fastest way possible to save lives. The most prominent example is the launch of the adaptive platform study, Solidarity, by the World Health Organization and its partners. Solidarity was initiated to study four COVID-19 treatment regimens with the ability to seamlessly add other investigational treatment study arms. In addition, Solidarity’s design reduces administrative demands on clinical study sites, particularly important at this time when patients with COVID-19 are overwhelming healthcare systems in many of the more than 100 countries participating in the study.
While Solidarity will raise the visibility of platform studies, it is EU PEARL that will deliver the operational, legal, ethical and regulatory framework needed to ensure this innovative approach is adopted for a much broader range of diseases.
Among our EU PEARL collaborators are physicians actively caring for COVID-19 patients and experts collaborating in the design of protocols and trials for COVID-19 studies. The experience we quickly gain through this pandemic will enrich our capabilities to successfully implement EU PEARL.
In our roles in industry, hospitals, and research institutions, we see one clear lesson from the current emergency: we must unite. Ideally, for rapidly evolving pandemics, research should be global, and at the very least must be coordinated by central pandemic research teams, such as the WHO or EU-based structures, working in collaboration to ensure valid and rapid results. Lives depend on our ability to improve upon the way we have approached clinical research in the past.
The choice of the WHO to adopt an innovative design for Solidarity underscores the timeliness of EU PEARL and the importance of its mission. It also provides opportunities for our EU PEARL efforts including gathering and applying learnings and best practices from teams currently developing platform study frameworks to address COVID-19.
Although the concept of EU-PEARL pre-dates the emergence of this novel coronavirus, and the initiative is not designed to solve or improve response to pandemics, the EU-PEARL frameworks created through the initiative may assist in the rapid design of global platform trials for future pandemics. The promise and urgency of EU-PEARL has never been more evident. When complete, EU PEARL frameworks will be in high demand for all research teams creating multicompany and multipartner platform trials around the world.
We look forward to continuing to collaborate through EU PEARL to bring the benefits of platform trials to many more patients in the years ahead.
Ann Van Dessel is EU-PEARL’s project leader. She is Head of JNJ Regulatory and Clinical Operations at JNJ.
Joan Genescà is EU-PEARL’s project coordinator. He is Chief Liver Unit at Vall d’Hebron Barcelona Hospital Campus and Professor of Medicine at Universitat Autònoma de Barcelona (UAB). He also heads the Liver Diseases group at Vall d’Hebron Research Institute (VHIR).