Innovative Drug European Associates

Silver Linings: How Regulatory Learnings from the Covid-19 Pandemic Could Bring Future Improvements to Research

I’m a huge believer that even in the very worst of circumstances, there is always a silver lining (or two) to be found. We  have already seen some of these playing out during this pandemic in the many ways people are coming together to spread hope and goodwill between and across communities. One positive that the coronavirus might bring specifically to regulatory processes for medicine and medical devices, is a shortening of response times from the regulatory authorities and better ways to share information simultaneously between global authorities, leading to improved harmonisation. The COVID-19 pandemic has forced regulators to find new ways of communicating on global projects and to act urgently to deal with this unpredictable and critical situation.

To address the coronavirus effort, regulators have adopted new processes and are making use of interoperable databases and systems to share information. They are using these systems and processes to ensure studies and data from coronavirus research are widely and rapidly shared in order to speed up the process of bringing vaccines and treatments to patients.

I certainly hope – and expect — that there will be some trickle down from those learnings once this crisis is over. Allowing the life sciences industry and academia to push forward with efforts to improve global harmonisation when it comes to sharing data and study results. More rapid, harmonised approaches will ensure that everyone in the research community is aware of what is working and what is not in each disease category so that discovery efforts and clinical trials aren’t focused on areas that have been shown to be ineffective elsewhere.

These next few months will be crucial for achieving the breakthroughs needed to tackle the pandemic, and good regulatory processes will be key to advancing those objectives. Times of crisis are often the catalyst for positive change and there’s every reason to be optimistic that this current sense of urgency will help us improve the regulatory landscape and lead to better processes for all breakthrough therapies in the future.

The fact is that, as an industry, we’re good at recording what we do day-to-day. It is what researchers do, and it’s part of our Good Practices – we carefully record data because if we don’t write down what we did and what we observed, it didn’t happen (according to the audit trail at least). If we record the learnings we gain from this period and transfer those to regulatory processes more generally, we can at least say that some good has come out of a very dark period in our history.

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