Are we seeing a breakthrough in clinical trial efficiency?

I joined my first CRO as an “International Black Belt” in 2005. Having come from a forward-thinking manufacturer who had been implementing six sigma and lean philosophy, I was dumb-founded by what I saw. After the first few weeks, I mentioned to a colleague that most of what seemed to happen in clinical trials was about checking because the process could not be relied on to be right the first time. Manufacturing learned in the 1980s and 1990s that checking (or “inspection” as they call it) is costly, inefficient, and ineffective. This colleague recently repeated this back to me. We’ve all seen examples in clinical trial – TMF documents being checked before sending, checked on receipt, then checked during regular QCs; reports going through endless rounds of review; data queries being raised for items that can have no impact on trial results or patients. When challenged, often the response is that we’ve always done it that way. Or that QA, or the regulators, tell us we have to do it that way. I’ve spent my career in clinical trials trying to get people to focus on the process:

- What is the purpose?
- What are the inputs and outputs?
- What is the most efficient way to get from one to the other?
- How can we measure the process use the measurement to continuously improve?
- What is the perspective of the “customers” of the process?
- What should we do when a process goes wrong?

And I’ve had a number of successes along the way – the most satisfying of which is when someone has an “Aha!” moment and takes the ideas and runs with them. Mapping a process themselves to highlight where there are opportunities to improve, for example. But I do often wonder why it is so difficult to get the industry to make the significant changes that we all know it needs. Process improvement should not be seen as an optional extra. It is a necessity to stay in business. It seems unfair to blame regulators who have been pushing us along to be process focused – for example with the introduction of Quality Tolerance Limits in GCP in 2016.

COVID-19 has caused so much loss of life and impacted everybody’s lives. It has been hugely to the detriment of the people of the world. And yet, there are some positives too. In clinical trials, suddenly, people are starting to ask “how can we make this change?” rather than “why can’t we make this change?” At meetings in the Metrics Champion Consortium we have heard stories of cycle times that were thought impossible for developing a protocol, for example, of a company that has switched from 100% Source Document Verification to 0% after reviewing evidence of the ineffectiveness of the process; and of companies implementing remote and centralized monitoring in record time. There are some great examples from the COVID-19 RECOVER study in the UK. And, at the same time, pharmaceuticals and the associated clinical trials are seen as critical to helping us turn the corner of the pandemic.

Let’s hope this new-found momentum to improve continues in our industry when this pandemic is finally declared over. And we can bring new therapies to patients much quicker in the future – with less cost and with quality and safety as high or even higher than in the past. We are showing what’s possible. Let’s continue to challenge each other on that assumption that because we’ve always done things one way, we have to continue.

Picture – Gerd Altmann, Needpix.com