The last years ushered in a new era of collaboration and flexibility. Now we must ensure the integrity of our scientific processes amid this shift.
Normally, medical treatments require lengthy development cycles and approval processes. But when COVID-19 struck our society, no one wanted to wait. Given the rate of contagion and the need for relief felt by health care systems around the world, few if any medical professionals raised objections to redesigning the authorization process to deprioritize long-term data in favor of achieving results in the shortest possible time.
All of us saw how swiftly the global scientific community was able to step up: utilizing advances in technology and cooperation to create a pioneering, lightning-fast collaboration.
An industry that is usually extremely structured adjusted its processes. Researchers shared their data across borders. Regulatory bodies in Europe and the U. S. cooperated extensively with private companies. Scientists adapted their previous knowledge of earlier viruses to this new challenge. This is, in many ways, a tremendous victory. The ability to gather, share and analyze data has reached new heights. But we must not lose sight of a key piece of the scientific process that risks being left behind amid these technologically enabled advances: The scientific community must continue fostering debate and building consensus — and it must be done in a way that keeps pace with these new, accelerated decision-making processes.
Data Isn’t Enough
Why is debate so essential? Because data will always require interpretation. For centuries, the practice of science has relied on the sharing of ideas and data derived from experiments. By sharing information in a way that allows it to be fact-checked, scientists are able to build on each other’s results, overcome their own limitations and participate in discovery processes on a global scale. This exchange has taken place primarily through two channels: publishing (for example in scientific reviews) and meeting (for example in professional gatherings).
It is only through this kind of interplay that scientists can hash out their differences and co-create consensus. As modern technologies and circumstances allow — and, at times, require — us to accelerate data production and analysis, we must also find ways to facilitate rapid debate. It is essential in a system as complex as the life sciences arena, especially in this new, COVID-era landscape, with its plurality of stakeholders.
Bolstering Deliberation: The Need for Debate
To maintain the integrity of the scientific community’s judgment, we must match these new technological and scientific achievements with equally powerful social innovations.
Firstly, we must raise public awareness of the reality that all data requires interpretation, and that in matters of public health this vital task is the responsibility of regulatory agencies. In addition, regulatory agencies must encourage vibrant — and transparent — debate within their own ranks. Enabling the scientific community to have timely and easy access to this sort of vigorous discourse is perhaps the best way to inspire trust in accelerated and/or innovative treatments.
But the need for internal debate at these agencies is more than a matter of public relations. When circumstances change drastically (whether due to a new virus like COVID-19 or due to groundbreaking treatment models such as gene therapy), these kinds of engagement are the best way to ensure that new approval processes are safe.
The need for a renewed support for debate doesn’t stop there. Whether internal-only or visible to the public, we know that every clinical study must be accompanied by a debate among experts considering the structure and parameters of the study. This is especially true when it comes to the accelerated and novel treatments we expect to see in the coming years. We argue that the time to put these measures in place is now — before the next urgent call to action.