Risk-based quality management (RBQM) is nothing new – it's been around in some form or another for a long time – but over that time, it has evolved into a strategy that is fast becoming the operational foundation of next generation clinical research.
Integrating quality into the design of trials creates an effective framework for addressing risks to patients, data integrity and regulatory compliance – the three cornerstones of clinical research.
In particular, two factors have led to the rapid acceleration of adapting RBQM into research – huge technological advances such as AI and increased digitisation; and COVID, which was a powerful driver in forcing researchers to put those technological transformations to immediate use.
Regulators have also evolved, coming in more quickly with guidance especially with how we need to keep a patient's voice at the epicentre research.
So, what can a typical risk-based framework look like now?
Traditionally, risk assessment was concentrated on the operational delivery but that has expanded and evolved into taking a more end-to-end approach. Every step can be examined, and the risks assessed – from the protocol, the operational risks, through the risk to patients and on to the commercial end. In looking at all these elements individually and collectively, the right decisions can be taken at the right time to advance to the next stages in the trial.
The factors in determining risk, too, are vital to the overall comprehensive approach – how severe is the risk? Is it negligible or will it do actual harm to a patient? What is the actual chance of that risk being realised?
Overfocusing on risk, of course, can stymie progress so it’s important to have perspective and remember that not all risks are equal, and also that risk is an ever-changing thing.
So, what about the future? Technological innovations will remain a game changer, providing us with huge amounts of invaluable data. That data, used meangingfully, will enable researchers to take action in real time and thus become more proactive than in the past.
It’s a process that has required evolution, but through innovation and making RBQM part of the way that clinical research is conducted, there’s an opportunity for real change in how the industry makes progress safely.
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