If we could learn only two things from the last few months, they are that lack of preparedness can cost lives and livelihoods, and that rapid change and collaboration can yield amazing results. Prior to Covid-19 the level of investment required to prepare for a pandemic was perceived by many as outlandish – perhaps it may never happen and most probably there were more important things right then and there that needed to be prioritised. However, as Bill Gates said in his Ted Talk “The next outbreak, we’re not ready” the investment would be modest compared to the potential harm.
Before this pandemic many people hadn’t heard of clinical research and gave little thought to how their medical treatments are tested, manufactured and distributed. Now clinical research carries the hopes of the world – not just in finding solutions to Covid-19, but also in finding treatments for the millions of people suffering from long-Covid. As an industry we have had to move at a faster pace than we have ever moved before, rapidly adopting new ways of working and collaborating at a level we had never experienced before. However, in this fast-paced environment it’s important that we also take stock and learn: What have we done well? Not so well? What could be done even better?
With the benefit of hindsight potentially many of the tragedies and ethical issues that shaped current ICH-GCP could also have been avoided. So as an industry we need to consider risk mitigation not just in terms of what the Regulations require us to do, but also in terms doing what we know is right, ensuring that we do everything in our power to avoid risk to patient safety and data integrity. We need to look at how our business processes and clinical research strategies are underpinned by solid foundations in terms of people, processes and systems.
We can learn a lot with the benefit of hindsight, but as we look to broaden collaborations and solve the biggest health issue the world has faced for a hundred years strategic foresight, quality, capacity, pace and risk reduction are the strategic imperatives and the reasons why IAOCR and GCSA continue to be dedicated to shaping best practice frameworks, facilitating broad collaborations and pioneering industry standards. As Bill Gates says “This is not the movies. We have one chance”!