The SARS-CoV-2 virus presented the world with a host of clinical challenges, not least its rapid transmission rate and ability to mutate into new, possibly even more contagious variants.
New vaccines, therapeutics, and diagnostics had to be tested under unusual and unpredictable circumstances; the most promising studies weren’t necessarily prioritized for high-quality clinical trials and competed for study participants; pandemic waves swept across the globe without real-time data; and feedback from health authorities varied significantly from one part of the world to the next.
Against that backdrop, companies and institutions running clinical trials tried to keep pace with the pandemic as it swept across geographical borders.
The future of global pandemic response is top of mind for me, in my role leading a global drug development organization with more than 500 ongoing clinical trials and as a member of the international Pandemic Preparedness Partnership steering group, which is chaired by Sir Patrick Vallance, the United Kingdom’s chief scientific adviser. This group will report to leaders at the G7 Summit on June 12.
Ahead of the meeting, the U.K., which holds this year’s presidency of the group, announced in collaboration with life science industry leaders an ambitious plan to join forces on developing and deploying new treatment within just 100 days after a new pandemic threat is identified.
Unlocking a global response that makes it possible to develop new molecules and run agile and internationally mobile clinical trials at the speed required to contain a new pandemic will be essential to achieving this mission. With the benefit of hindsight and following a monumental — and continued — effort on the part of so many fighting Covid-19, here are three opportunities for focusing our efforts. While much has been learned about vaccines and diagnostics, this article focuses on the development of new treatments.
An infrastructure to prioritize the most promising compounds
As I write this, nearly 6,000 clinical studies have been registered on ClinicalTrials.gov for Covid-19. Without prioritization based on the available scientific data, the quality of the trials, and their probability of success, these trials — which often focus on the same agents or same mechanisms of action — compete to enroll for the same limited number of patients. Without an infrastructure or ability to pool data across studies, sponsors, and countries, many trials, including those testing the most promising compounds, cannot be completed, which slows the identification of the most effective treatments.
One potential solution comes in the form of a coordinated effort between pharmaceutical companies, academia, and governmental agencies as equal partners, enabling agents with the highest probability of success to be prioritized and avoiding duplicative efforts through access to shared data.
In the U.S., the ACTIV partnership, which brings 18 pharmaceutical companies together with academic experts and U.S. government agencies such as the Biomedical Advanced Research and Development Authority and the Centers for Disease Control and Prevention could be a model to inform the infrastructure required for prioritizing potential therapeutics or diagnostics for future pandemics. It could also help support the creation of a coordinated global clinical network with capabilities for data sharing.
Global coordination of clinical trials with access to real-time epidemiological intelligence
Throughout the Covid-19 pandemic, feasibility assessments and patient recruitment capabilities have been highly variable across countries and continents because of rapidly changing infection rates. Evolving public health challenges and recommendations also affected all aspects of clinical trial design and implementation.
Enrolling participants in robust clinical trials with prioritized compounds quickly and efficiently requires real-time insights into pandemic waves and global public health challenges that must be paired with agile trial designs and clinical networks able to rapidly execute and adapt.
Creating a global clinical network assimilated by all stakeholders with access to real-time epidemiological intelligence employing predictive analytics and models would enable coordinated and agile execution so these trials can enroll patients quickly and safely despite fluctuations in infection rates. This would also foster flexibility in recruitment strategy in response to shifting pandemic waves and public health challenges, and would make site identification, initiation, and monitoring more efficient.
Coordinated global health authority feedback
During a pandemic, health authorities and industry have a common goal to develop new treatments as quickly as possible, while upholding efficacy, safety, and quality standards to protect public health. That requires assimilating real-time information on the evolving pandemic, the diagnostic and treatment landscape, and advances in scientific understanding of the pathogen and disease, and it is critical that health authorities and industry stay constantly aligned on these advances and the implications for regulatory science and clinical trial design. Feedback from health authorities during the Covid-19 pandemic on the design of clinical trial protocols varied significantly in different regions of the world. This slowed the initiation and execution of cross-border clinical trials.
Global alignment from key health authorities on harmonized clinical trial design, paired with a commitment to provide rapid and uniform feedback, would speed up simultaneous global initiation and execution of clinical trials. Within the International Coalition of Medical Regulatory Authorities, 29 global health authorities actively collaborated and shared information throughout the Covid-19 pandemic. In addition, many of these health authorities have applied successful reliance regulatory pathways previously, relying on another health authorities’ assessment or sharing the review workload. This could be considered a mechanism to build on.
Taking the lessons forward
These three opportunities are closely interlinked. High-quality clinical trials for prioritized treatments would be supported by global coordination and greater access to reliable real-time epidemiological intelligence. Mechanisms to coordinate data on treatments and shifting pandemic waves, as well as health authority feedback, would inform a more cohesive global response. Beyond clinical trial design, it also offers additional opportunities for synergy within related areas such as technical product development, supply chain, and manufacturing, which have moved into focus with the current state of the Covid-19 pandemic.
There are real lessons to be learned from the past 18 months, and although it may feel paradoxical to be preparing for an unknown future pandemic when Covid-19 is still largely present, increasing coordination to build agility and resilience into clinical trials is the future of pandemic preparedness — and that future starts now.
John Tsai is head of global drug development and chief medical officer for Novartis and a member of the Pandemic Preparedness Partnership steering group.
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