Thanks to the COVID-19 pandemic, the general public knows more about clinical trials for drug development than ever before. Throughout 2020, people all over the world learned how biopharma was working nonstop to identify promising vaccine candidates, eagerly watched for updates on clinical trial initiation and progress, and cheered when the FDA granted Emergency Use Authorization.
The fact that the world’s collective hopes were realized speaks to the extraordinary effort, commitment, and drive of talented clinical research and development professionals at Pfizer-BioNTech, Moderna, and Johnson & Johnson/Janssen, as well as the partners who supported them.
The ability to safely, effectively, and transparently develop life-saving COVID-19 vaccines in record time throws into stark relief two situations that are diametrically opposed to this success. Both of these must be addressed in order to maintain public confidence in the clinical trial process, which many people now credit with saving their lives during this past year.
The first involves reports in mid-May 2021 about the investigational COVID-19 antibody treatment Leronlimab. While Cytoden asserted efficacy based on clinical trials, the FDA determined that final trial results did not support those claims. Such misrepresentation undermines the public’s newly heightened awareness of, investment in, and reliance on the ability of biopharma to conduct and accurately report on clinical trial outcomes.
The second situation that must be addressed involves outdated clinical trial processes. Until the advent of COVID-19, the standard drug development timeline was measured in years. However, during the global pandemic, the life sciences industry compressed that period to nine short months–an unheard-of phenomenon.
The passionate leaders of biopharma used every tool at their disposal to turn the tide on this global public health threat in record time. By leveraging decades of incredible science and the power of artificial intelligence (AI), visionary leaders catapulted clinical trials from an archaic to a 21st-century standard. Now that the world has had a taste of what is possible with science and AI, it is unlikely that anything less should be accepted in the future.
The world owes the life sciences industry its gratitude and appreciation for its astounding acceleration of COVID-19 therapies and vaccines. A default to pre-pandemic timelines and clinical trial processes will not be tolerated by a global population with an ever-increasing clinical trial IQ, and that is a good thing. We as an industry must challenge ourselves to meet these newly established benchmarks by embracing technological innovation with the same rigor that’s been applied to scientific innovation over the last few decades.
I encourage the life sciences industry and all of its partners to move forward, not backward, when it comes to clinical research. Let’s continue to astound and amaze the world by applying the same technology, passion, and commitment to accelerating clinical research for all diseases as we did for COVID-19.
