PICO Ahoy!

Both agencies and pharmaceutical companies appear to be raising the alarm to general quarters, largely due to the advent of Joint Clinical Assessments (JCAs) currently being implemented across Europe and how they approach indirect treatment comparisons utilising PICOs (Population, Intervention, Comparator, Outcomes)

But what’s fueling this kerfuffle? Is this a new trend, or is it unexpected? The short answer to both is “no!”

The current evolution in this field has been underway for nearly two decades, steadily gaining traction among Health Technology Assessment (HTA) bodies since the late 1990s. This shift is particularly evident in the increased emphasis on systematic reviews and meta-analyses in healthcare decision-making, especially in countries like the UK and Canada

So, why the commotion?

As Hector Barbossa aptly puts it, “The code is more what you'd call 'guidelines' than actual rules.”

This quote from Pirates of the Caribbean perfectly captures the situation. For years, various voices have suggested that development plans must adapt to these emerging trends. Yet, due to their historically localised impact and non-mandatory nature, global teams have often ignored this counsel

This oversight may have been detrimental, impacting both historical assets and those currently seeking marketing authorisation, as valuable opportunities for optimal study design and data generation have likely been missed. In hindsight, a preventable mistake

But what of the future and will JCAs finally shift the balance? Perhaps, perhaps not

Sometimes folks need to see the grappling hooks before adjusting course. PICO ahoy indeed