How Do We Get Drug Labeling Based on Patient Reported Outcomes?

With Ari Gnanasakthy, MBA, MSc, Principal Scientist, Patient-Centered Outcomes Assessment at RTI Health Solutions.


A frequent request we receive from clients relates to labeling, and we often get requests saying we want label based on some questionnaire - EQ-5D or QLQ-C30 or AQLQ or something along those lines. This is often a sign that the study team has not thought through the whole process of getting a labeling from regulators - the FDA or the EMA.

Before we start the process of labeling, the important thing to realize is that - what is it that we want to say? What is it that you want to say? What is the value message? What's the value proposition in simple language that can be understood by patients or other stakeholders as well.

There is no point of having a labeling language full of statistical jargon, like hazard ratios, and p-values, and the name of the instruments. It's important that the value message is patient friendly and simple. And there are good examples of that.

It's important that we decide on the value message - the simple value message - before we go to proposal.

So how to get there?

This means once we decide on the message - simple message - then we go through the process of thinking about the questionnaire, the analysis planning, the assessment schedule, the briefing book, the interactions with the regulators, the dossiers, and so on and so forth. So, you realize there's a lot involved when pursuing a labeling.

We are only happy to go through this process of helping you to understand the pros and the cons - how you get there. And this may save you a lot of heartache, headache, and resources.