In response to Covid-19, the global drug development community has moved faster and further than ever before. But what did we learn from this emergency? Actors across the ecosystem, from drug developers to regulators, are considering how we can apply practical insights for the benefit of patients in the future.
While drug developers were able to quickly develop safe and effective vaccines, much time and resources were wasted on projects that doubled the effort or ignored existing scientific evidence. Implementing the lessons learned and reusing tools effectively used during this pandemic will be critical to hit the next one. Future drug research and development programs need to make more extensive use of these three strategies:
Rethink clinical trials
The average cost to get a drug to market is approximately $ 2 billion, more than half of which is invested in clinical trials. Traditionally, researchers recruited patients whose main benefit was their availability, and therefore many drugs have been developed without ethnically, economically, or geographically diverse clinical study populations. The pandemic pushed researchers into telemedical and technology-enabled decentralized studies, which continued despite the raging pandemic. As more people become available for study, drugs and dosages can be developed more effectively and accurately than ever before for more types of patients.
But before doing clinical trials, many researchers used biosimulation, which uses in-silico computer-based modeling with virtual patients. The fast and relatively inexpensive biosimulation provides a wealth of information about how a drug would work and how best to design a study before the drug is ever tested on patients. The demand for speed has brought biosimulation to the fore and has further developed the way of thinking and practice in the direction of computer-based experiments. I am proud that the organization I lead has worked with developers of Covid-19 vaccines and therapeutics to optimize the study design and dosage for different populations through biosimulation.
Working together to accelerate actions
During Covid-19, the scope and effectiveness of the collaboration was unprecedented, with results shown in the astounding pace of vaccine development and approvals. Still, there is plenty of room for improvement in 2020 due to the pitfalls.
Establishing cooperative clinical studies took too long. When they started there was wasteful duplication: 218 clinical trials tested hydroxychloroquine; many open source projects were ‘closed’ rather than ‘open’; and poorly designed, repetitive studies for Covid-19 treatments gave little insight into what worked and what didn’t. In an emergency, time and resources are limited; we could have used both better.
The UK stood out for its collaboration with its national studies. A large study of dexamethasone has shown that the cheap, widely used steroid significantly reduces recovery time in severe Covid-19 cases. This study was successful because the UK NHS was able to conduct efficient, randomized studies coordinated with a central repository in more than 176 hospitals.
Proactively prepare for the next pandemics
At the beginning of the pandemic we learned the lesson in the Boy Scout motto again: “Be prepared”. The U.S. government has so far spent or invested a staggering $ 8 trillion reactively on the pandemic, which does not yet include the enormous toll of human suffering.
Preparing for future pandemics is a serious investment today and means securing supplies and supplies of critical materials, planning controls and communications, and ensuring drug development systems remain able to develop the vaccines and treatments they need. We can also prepare by actively tracking known and emerging threats, modeling their likely spread, and running scenarios of potential cures and treatments. Public-private partnerships should be encouraged; NGOs like the Bill & Melinda Gates Foundation played an important role in working with drug developers to accelerate treatments and vaccines through collaborative action and data coordination.
Covid-19 teaches us many lessons the hard way. Sector-wide, innovative approaches such as virtual trials and accelerated approval routes were adopted out of necessity, and hard-won insights resulted in vaccines and treatments developed in record time. This pandemic has shown that collaboration, biosimulation and decentralized studies, as well as active preparation programs, lead to fast and effective drug development when we really need it.
These successes will change future drug development. Not only must we incorporate these findings into our planning for the next pandemic, but we must apply them to all of our drug development efforts so that we can accelerate the development of new drugs for those in need.
Photo: metamorworks, Getty Images