Thanks to the COVID-19 pandemic, the general public probably knows more about Clinical trials for drug development than ever before. Throughout 2020, people all over the world anxiously consumed news accounts of how biopharma was working nonstop to identify promising vaccine candidates, eagerly watched for updates on clinical trial initiation and progress, held their breath as the FDA evaluated prospective therapies, and cheered when Emergency Use Authorization was granted.
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 and must be addressed in order to maintain public confidence in the clinical trial process many people now credit with saving their lives during this past year.
The first involves reports this week about the FDA’s determination that Cytoden’s claims about the efficacy of its investigational COVID-19 antibody treatment leronlimab, which the company said were based on clinical trial data, were not in fact supported by final trial results.
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The second situation that must be addressed is how outdated traditional clinical trial processes were prior to the global pandemic. Until the advent of COVID-19 the standard timeline for drug development was a very long, drawn out process. However, during the global pandemic the life sciences industry compressed that period to nine short months – an unheard of phenomena. The passionate leaders of biopharma leveraged every tool at their disposal to turn the tide on this global public health threat. By leveraging decades of incredible science and the power of artificial intelligence (AI), these visionary leaders catapulted clinical trials from archaic to 21st century standard. Though it is true that the entire world united to achieve this goal, that is no excuse for not making this our standard for curing/preventing the illnesses amongst humanity. 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 the astounding acceleration of COVID-19 therapies and vaccines achieved this past year. A default to pre-pandemic timelines and clinical trial processes must 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 integrating technological innovation into the clinical trials process with the same rigor with which we integrated scientific innovation over the last few decades.
Beginning today, on Clinical Trials Day 2021, let the life sciences industry and all of its partners make it our mandate to maintain this new level of achievement forced from us by COVID-19. Let us move forward, not backwards, and continue to astound and amaze the world by applying the same technology, passion, and commitment to accelerating clinical research for all diseases.
