The importance of the patient voice in clinical trials

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Published: 21 Mar 2019
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Prof Anne-Sophie Darlington - University of Southampton, Southampton, UK

Prof Anne-Sophie Darlington speaks to ecancer at the 2019 EORTC Groups Annual Meeting (EGAM) about the importance of including the patient's experiences and voice during clinical trial assessments.

Prof Darlington details the use of questionnaires to measure these patient parameters and how these must be carefully developed to allow flexibility to withstand the evolving environment of clinical trial research.

What’s really important is that when we run clinical trials that we include the patients’ experiences and include their voice in making assessments on whether or not a clinical trial is successful. So that’s the essence of it. What I will be talking about is understanding why we should include the patient voice and their experiences in clinical trials; what we do with that data and how we best measure that. So how do you get the best information from patients.

Now, in our group, in the quality of life group, we have developed questionnaires and one of the very core questionnaires for cancer patients is a QLQ-C30 which is the most widely used measure for clinical trials in the world.

What are the current challenges you face?

Obviously what we want to be able to do, we want to ask them the right questions. We don’t want to ask them too many questions because they have to be relevant and they have to be precise. So we develop questionnaires in our group but that can take some time. With all the new treatments and the really rapid development of those new treatments we have to be quite agile and quite flexible in the way that we assess these things. So our challenge is to find the best way to find the right questions to ask but making sure that we make sure that that process is done well so we cover the right issues.

What are the next steps for addressing these challenges?

What we have done in our group is really thought about how can we be very flexible while safeguarding the quality of our measures. Because what we don’t want is for people to develop measures without the proper processes in place. So we want to make sure that we adjust our processes and have a combination of questionnaires that have been developed and we call them static questionnaires, in the sense that the questions in those questionnaires stay the same, but combine that with very flexible item lists. So what you would want to see is if a trial is testing a drug and actually some patients are experiencing high levels of some specific symptom, that we are able to measure that.

How does your measure compare to others?

Like I said, we have the most widely used measure that we have in the group so that is really powerful. That means as well that we have a lot of data and a lot of history to build upon so that we can make sure that the quality is there and that’s really important for us.

Is there anything else you’d like to add?

I do a lot of work with young people as well. So within the group we want to make sure that we assess quality of life in young people, so teenagers and young adults, which is a very, very important group to consider. And that we make sure that actually the questions are relevant for younger people like education and fertility and employment and the issues that they feel around that.