 Hello Engulf, it's a pleasure to be here and to see you again. Hi Andrew, it's also a pleasure for me. Could you tell us a little bit about the Z-Qualiome eye consortium and its objectives? Yeah, of course I can. Well, I'm sure everybody knows that when we do research and when we're examining the patient's perspective, that's called quality of life research. Well, we really go and ask the patient about their disease, about how the treatment and how that's directly impacting on them. We've been doing this for at least the last 10 years in a very systematic and robust manner. If you look back in the literature, you'll see that quality of life research is now done in a very much a standardised way in most clinical trials that are run by academics and industry. However, while we've got better at doing these new standards by creating new tools, by designing new trials and publishing these trials in a standardised way, we still have one major gap. And that's having the standards that will guide us in the analysis of such data. So Ingolf, why do you think funding from the EU Innovative Medicine Initiative is actually so important for this work? First of all, we are very pleased that the EU Innovative Medicine Initiative created this in need and issued a funding call afterwards for researchers from industry and academia to collaborate together, which is very important here. And they want us to create an international consortium of experts who job it is to fix this problem. And our job as a consortium is to come up with a set of standards for how we can analyse quality of life data in cancer clinic trials and that trials that are done across the spectrum in both academic and industry setting and sponsored trials. So how did the project start, Andrew? Interesting question. You and I have always had an interest in how we standardise the work in the quality of life field. And I think our early work, we were able to pull a large group of experts, if you remember, from across different disciplines in different countries. Well, the IMI funding tools, it allows us to expand that group and to include more type of participants from disciplines and many other countries. We are now very happy to say that we've got a big consortium with more than 41 partners and stakeholders that really represent academics, regulatory agencies such as the FDA, the EMEA and HTEA bodies too. And of course, not forgetting critically, patients. So Ingolf, why is the involvement of pharmaceutical industry so important for the CISACOR consortium? Thanks, Andrew. I think the industry does a lot of clinical trials and it's so important to have the perspective of the industry because of this. And we've found so many trials to support the development of innovative medicines for patients in need. And hence, all the work packages are co-led by someone representing the public as well as the private side. But more importantly, I'm also very proud that we are also including patient consortium to learn about their needs and their specific perspective since we are dealing with the data that is uniquely provided by them. And they are so important that we decided that they also lead a full work package and have been integral also in the designing of the work of our consortium. And again, what unifies all of us regardless of whether we work for regulatory or HEA agencies for academia and industry is our shared vision that PRO data are more used than actually decision making in the future. And ultimately, and this is our big hope, we hope that these data should inform conversations between doctors and their patient of which treatment is the best for them. Can you briefly describe the scientific scope of the project and issues that you will be tackling? Yes, so our consortium actually has more than 180 members. We've already met virtually and in person and we started to prioritize our activities. We have researchers that will actually be making guidelines on how we have to analyze quality of life data from randomized clinical trials as well as single-arm trials. We have researchers who will be looking at how we should best present that data and how clinically meaningful that data will be. And of course, we have a very important work stream we'll be working on about how to present that data best to patients. So patients themselves can really fully and easily understand their data directly themselves. So Ingolf, why have these issues really not been resolved before? Andrew, I think that's a very good question and we have to say there's been a large amount of evidence provided on all of these topics, though there's data and papers out there and plenty of them. However, these often come from the perspective of one group of stakeholders, for example, such as statisticians, clinicians or psychologists. And we think, of course, this is valuable, but there's no consensus that involved all relevant stakeholders on the best methods to be used under which circumstances and how the results should be presented to all the stakeholders such as regulators, HTA bodies and clinicians and patients alike. Why is consensus and for among all these different stakeholders so critical to our work? So indeed, as you say, it is indeed critical for the work of the Cisco IMI consortium. What we're going to be doing is pulling together all these evidence, we'll be debating that evidence in a very critical manner. Then, following a really standardized process, we'll be trying to get consensus from across these 41 different organizations. So we'll be trying to do something that's really never been achieved yet and we're trying to get something done in research in a very standardized and systematic manner. So how is the work of the Cisco IMI relevant in practicing Goal? Well, it's because quality of life, symptom and functional limitation, they are such now a standard endpoint and we really need doctors, researchers, patients to be confident with the results that we show to them that means that we should not have near identical traits using very different analysis methods which we sometimes see in the literature that they give very different results and we need now to create standards and guidelines that everyone can fit on a global stage and that can be understood and followed and they give some confidence to researchers, patients and everyone looking at the results of our studies. And how do you rate the difficulty of providing global standards in the design and analysis of patient reported outcomes? You see, it may seem on the face of it a very easy project we're simply pulling existing standards together we're simply speaking to each other and we're deciding what's acceptable. However, if it was such an easy task this would have been resolved at least a decade ago or even longer. You see, in reality quality of life is still an evolving science. Now we've made huge steps in how we create measures we've got a lot of agreement on how we design trials but this is the final major gap that we've got to address. So we have a bunch of world-class stakeholders who have agreed to help who have taken a great deal of trouble to design our current work and because of that I think we are in a very good place to get the end results that we really need. Indeed, and for I think we are confident that we pour the existing data and publications over the coming years and as we start to have discussion and debate the experts in the consortium will do their very best to come to agreements or consensus on further analysis standards. At the end we don't have a choice. We have to move on our standards and improve so that the views of patients are given greater weight than ever before in decision-making. Well Engel, thank you for taking the time today to discuss this as a consortium. It's really been a pleasure. Thanks and for the pleasures on my side as well. Well thanks everybody for taking the time to listen to our video. Please do keep in touch on our website. You will see that we've got lots of other videos from academics, from the HTA bodies and even from patients talking about what the CISACO consortium does. In addition to that, as we develop the guidelines we'll be putting them on the website and we'll be encouraging you to comment and give us some feedback. So thank you again for taking the time to listen today. Bye bye.