Updated: May 15
The future is volatile and unpredictable. We can’t know for certain what’s going to happen, but we can plan for different scenarios. So why were so few companies ready for a global pandemic and international lockdown? Were you? And more importantly, what are you doing about ensuring your company is a winner coming out of this crisis, and not a loser?
The regulatory authorities have been trying for years to get companies to adopt risk-based quality management, but large numbers are still either pre- or mid- adoption. COVID-19 has forced risk management to the top of the agenda of every executive in the sector.
Every company involved in the planning or conduct of clinical trials has been affected by COVID-19. It has stopped patient and site visits, created supply shortages and logistical issues, restricted access to site staff and patients. It has accelerated the use of technology in trials and in operations, and forced both sponsors and CROs to re-evaluate and change long-established ways of working. For many it has raised a significant question: why would we go back to the old ways when we have proven we can do things differently/better/faster/more effectively?
For example, the ability to source data verify on site has almost disappeared overnight, so companies are having to find more efficient and effective ways to assess data quality and proactively identify risks to data quality and patient safety.
Having overcome the initial impact, many companies are already looking beyond lock-down to the future and working out how to restart stalled studies. They are also asking themselves difficult questions like, “how do we future-proof both new and existing studies”, and “what can we learn from this situation and how do we make our business more agile and robust for the future?”
That leads to the next important question, “how do we ‘right-size’ our business?” That means cutting out what is not required in order to focus on what’s really important to future success. ‘Right-sizing’ means something different for every business because each is unique, but there are some common themes appearing that are important.
One thing that leading organisations are doing is improving their risk planning. COVID-19 isn’t the first pandemic, and it won’t be the last. But it has opened people’s eyes to other significant risks, such as environmental, economic and geopolitical risks that can have a detrimental impact on studies. Environmental impacts such as fire, flood, hurricanes and volcanoes have all impacted people’s ability to travel in certain parts of the world over recent years. If, as many commentators predict, there is a global recession looming, what impact will that have on trials? Given the huge, different and varied risks, what could and what should we do to try and ensure business continuity?
One of the questions we get asked most often is, “What are other people doing?” Without breaching any client confidentiality, over the coming weeks, we’re going to be sharing ideas and good practice from what we’re seeing from companies from Asia, Europe and the US. What has been interesting is the willingness of so many people to collaborate because this is new and challenging for everybody.
While the future is volatile and unpredictable, we can all make plans to reduce risks and better ensure that we are ‘winners’ coming out of a crisis. To help with your thinking, we’ve put together a series of 9 webinars with associated materials with our view of how COVID-19 will change your trials forever:
How COVID-19 will change your trials forever (expanding on the themes and topics above)
How to bring your current trials out of COVID-19
Right-sizing your clinical trials and operations - What is ‘right-sizing’ and what’s possible?
Risk Assessment and Management
Integrated Strategic Monitoring Plans, remote and central monitoring
Reducing the fragility of your clinical portfolio
Change management and culture - life in the 90% economy
Safety, quality & efficiency - operational excellence examined
Why TRI are the best people to help you transform your clinical trials
If you have any comments, questions or observations about how COVID-19 will change clinical trials, please email me at firstname.lastname@example.org and as I’d love to hear from you.