CTA: What are the benefits of patient reported outcomes?

FM: It depends on your end point, but they allow getting real data from the patient without the interference of the investigator. It is real-world data, which is more reliable and on-time information. If you ask questions like ‘what pain did you have two weeks ago?’, the patient might not remember that. But when the patient provides this information at home, or on an ongoing basis via electronic diaries, we get more reliable data.

CTA: How does PregLem operate when it comes to patient reported outcomes?

FM: We use electronic diaries. We give patients smartphones with a special software inside and they complete the information at home.

CTA: What have been the challenges that you have seen so far?

FM: Sometimes it is difficult because the devices are not working as expected, or some patients have trouble filling in the data or the transfer of data does not work that well because the network in some countries is not very good. But we try very hard to make sure it works. Sometimes we use paper diaries as a backup, so in the end we do not have a lot of missing data.

CTA: What should be done to make the devices work more effectively?

FM: We have to keep it simple in terms of what kind of data we want to collect. You should not try to put everything into the electronic diary; you have to focus on your end point. Also, you have to try to ensure that data requires a minimal amount of manipulation from the investigator as well as ensuring the diary is easy to use for the patient.

CTA: So far, what have the results been for Preglem?

FM: The final outcomes have been good. We were quite happy with the results and with the data reported in terms of quantity and quality. This helps us a lot when it comes to approval from the European Commission.

CTA: Are patients willing to contribute?

FM: When the device works correctly, yes. When there is a bug in the system or it takes too long to transfer the data or it is too difficult to fill out the information, they might give up and stop completing the diary. That is why it is so important that we ensure the diary is simple and easy to use.

CTA: How do you ensure that your diaries are ‘patient-friendly’?

FM: We use a vendor for that. It is important that vendors understand our needs and that they explain to us the constraints they may be in place. They have to guide us along the way and not say yes to everything we say, so that we can put a proper system in place to enable us to get the results we need.