The use of PROs in early-phase trials

10 February 2023

Today in FridayScience something native to us – earlyphase clinical trials and Patient Reported Outcomes (PROs), which is becoming a ‘hot topic’.

PROs are becoming increasingly important in early-phase clinical trials as they provide insight into the benefits and risks of new drugs from a patient’s perspective. They can inform dosage selection, support regulatory review, and enhance PRO strategy in later-phase trials.

However, when developing a PRO strategy for early-phase trials, a number of methodological considerations should be addressed such as selecting appropriate concepts and measures, engaging with stakeholders, and specifying endpoints in advance.

Traditional measures for assessing safety and tolerability rely on clinical report, but it’s worth to note that patient reporting of adverse events and tolerability can provide an even more comprehensive insight into patient experience!

The use of PROs in early-phase trials is still limited but it is gradually increasing in fields such as #oncology and inflammatory disease.

Read more: Nature Medicine – The value of patient-reported outcomes in early-phase clinical trials