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PROactive draws to a close, delivers on its promises – an interview with project coordinators


Thierry Troosters

IMI: What is the chronic obstructive pulmonary disease (COPD) and why was it important to have a project such as PROactive in the first place?

Thierry Troosters: COPD is a very prevalent disease; it affects mainly smokers but also people who inhale noxious particles, for example in the workplace. It’s reasonable to say that about 10% of people over 45-50 suffer from this disease, which is a very large group of patients. Not everyone is symptomatic and needs the same treatment. The disease is complex because the main characteristic is progressive loss of lung function which makes exercise and physical activity difficult. That’s why this particular project – looking at physical activity and the experience of physical activity of patients with COPD - is so important: it tackles one of the main problems that these patients experience, often very early in the disease.

IMI: Could you tell us a bit more about the new tool you developed? What does it do and why is it important?

Thierry Troosters: By following guidelines outlined by the regulatory authorities, we developed a patient reported outcome (PRO) tool to accurately measure how patients with COPD experience physical activity. This is important as we are now capable of capturing an essential part of patients’ experience of COPD and improvements or deteriorations thereof. A decade ago, physical activity monitors became available and people began using them, but little was known on how to interpret the outcomes. Now we have a tool which allows us to not only look at the amount of physical activity in COPD patients, but also to capture patients’ experience of this physical activity. I am quite pleased to see this project come to an end with the deliverable we had anticipated: a PRO tool that captures something that is absolutely crucial in the lives of these patients. We have submitted the evidence to the European Medicines Agency (EMA) and are now waiting for them to qualify the tool.

Mario Scuri: Once we get the qualification from EMA, we will have a validated PRO tool in our toolbox which we can use in clinical trials.  For example, let’s say I am developing a new drug. If I conduct long-term trials and positively conclude that my drug is improving how patients experience physical activity, based on this PRO tool, I will be able to go to regulators and say my drug is providing patients with an added, patient-centred benefit. This added benefit can be added to label claims [health claims written on drug labels] which will have value for the pharmaceutical industry, but also for the patients.

IMI: Which aspect of the project are you most proud of?

Thierry Troosters: I am most proud of the fact that we have contributed to innovation in the field. We developed a PRO tool in an innovative way by merging questions that we ask patients about how they experience physical activity with information that we get through a wearable activity monitor. This makes the life of a patient easier: before PROactive, if we wanted to develop this type of a tool we would have to ask our patients lots of questions every day to get the same (or perhaps even less reliable) information. Now we give them the wearable activity monitor and we ask them 7 questions per day. It’s a simplification in the PRO field and an innovation which could be easily exported into other disease areas.

Mario Scuri: Indeed, the scientific innovation is very clear. I am also very proud of the level of coordination and cooperation between EFPIA and academia. I come from academia, but I have enough of years of experience in the industry to understand that such collaboration could be very challenging.  I was positively surprised that the collaboration was that efficient – it was smooth sailing although not always in still waters.

IMI: Are patients already benefiting from the outcome of the project?

Thierry Troosters: Yes, patients are already benefiting in general terms because in the last six years, physical activity has really climbed up the clinicians’ agenda. I am not going to claim that PROactive is the only reason for this, but having this IMI project with several  pharmaceutical companies, the European Respiratory Society, and the European Lung Foundation, all pushing the physical activity wagon in the same direction – this  has definitely changed the landscape around the patients with COPD. As Dr. Richard Zuwallack, an American pulmonologist recently told me, today clinicians are not necessarily asking their patients ‘how do you do’ but ‘what do you do’. That is an important game changer. Once clinicians are more aware that physical activity and the experience of physical activity are important for patients, they will also take action if they feel their patients fall short in these physical activities. Nowadays there are promising and potent drugs available for patients with COPD, but it’s very important to combine those with interventions that allow patients to use the increased lung capacity which they gain from these treatments. One must not forget that physical inactivity is the main driver of mortality in patients with this disease, and it is important to make sure they increase (or maintain) their level of physical activity as part of their treatment.

Mario Scuri: Patients who have been included in the clinical trials to test our tool have also received benefits. Furthermore, once the tool is qualified and implemented in other clinical trials, it will give more patients the opportunity to monitor their physical activity and to better understand whether the treatment they’re getting is beneficial for them in that regard.

IMI: Patient involvement was an important aspect of your project. Could you elaborate a bit on how you involved them?

Thierry Troosters: We involved patients very early on in the process: even in the writing of the original project intention we approached two patient organisations to make sure we developed a project that is relevant for them. Following that, we involved patients in all stages of research – for example, we consulted them during the initial development of the items for the questionnaire to ensure that it is in the language of the patients. We carefully listened to their opinions on the usability of activity monitors. We also involved them as managers, for example they were running our ethics committee. Patient organisations were also very important during the dissemination: we engaged both the British Lung Foundation and the Lung Foundation Netherlands to make sure the messages from the consortium reach the patient audience.

IMI: How did the public-private nature of IMI contribute to the success of this project? Would it have been possible without IMI?

Mario Scuri: I think it would have not been fundable otherwise – this collaboration was the only way that such type of a project could be conducted. For pharmaceutical companies, participating in this project meant getting into a different kind of business and without this type of collaboration it would have been more difficult to get into it in the first place. The academic community had the scientific rationale but I don’t think they could have come up with the funding for such a long-term project on their own.

Thierry Troosters: Without IMI, we would have missed out on the EFPIA expertise and resources. Thanks to this project, we have implemented this tool in their clinical trials and quickly got sufficient data to submit it to the regulators for approval. That wouldn’t have been possible without IMI. Obviously, as we were part of the first batch of IMI projects, there were growing pains with the funding and the commitments of partners, but we have always experienced the willingness to resolve issues and work towards our very concrete goals.

IMI: So the pharmaceutical industry will benefit from getting a new tool for their clinical trials and the patients will benefit from understanding which treatments are helping with their physical activity. How will the academic community benefit from this project?

Thierry Troosters: In many ways. Firstly, being part of this consortium has raised our own profiles as being at the forefront of physical activity research in respiratory diseases – that was a benefit for everyone involved. Also, with this consortium we’ve built a good group of researchers that are able to collaborate in an efficient way and we’re making plans to continue that collaboration in the future. Last but not least, we’ve learned to work with the EFPIA members. I am a physiotherapist so I didn’t have many interactions with the pharmaceutical industry before, but I found it a valuable resource. What made this project a success are the complementary backgrounds and knowledge from all these companies and academic institutions. Ultimately we now have an outcome measure tool that we can use in our own independent research. The tool is available in more than 50 languages and this will surely allow future, multi-centre research for the academic members.

IMI: Now that the project is over, what are the next steps?

Thierry Troosters: Within the IMI project, we were able to develop a new PRO tool which is now done and we’re at the end of the project. It would be a problematic if we just left it on the table for people to pick up, modify, translate incorrectly and do their own thing with it. We have expressed the willingness to continue with the consortium to make sure that the tool is properly used and managed. For example, if someone needs a translation of the tool, we want to make sure it’s done properly. If someone wants to develop a tool within a new disease area, we want to make sure this development is done properly. We also want to build on the tool that we have and develop further projects. Therefore, we signed a memorandum of understanding to maintain the consortium so that if other opportunities for funded research come along we can take those opportunities as a consortium rather than as individual researchers. The idea is to stay together and safeguard our baby. 

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