Aida Asks: Interview with Stan van Belkum

This is the third episode of Aida Asks, a series in which I interview different stakeholders within Life Sciences and Healthcare about their contribution to the future of health and the way we can foster innovation through regulation. I had a conversation with Stan van Belkum , the general secretary / director of Central Committee on Research Involving Human Subjects (CCMO) .

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Aida: Thank you for consenting to this interview. Within Deloitte, we have a view around the future of health. We see the shift from managing illnesses to prevention, the empowered consumer, focus on personalized therapies, and last but not least an increased development of therapies and improved therapy quality. So all these things can only happen if the players in the ecosystem take a different role or have an aligned mindset.

I would like to focus our conversation on CCMO's responsibilities, your own passion for change and your view around the future of health. But first of all I would like to ask you what your role in CCMO is.

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Stan: Well, first, let me say that the four topics you mentioned -from illness to prevention, empowered patients, personalized medicines and increased development- align perfectly with what the Ministry of Health, Welfare and Sport and CCMO envision for the future of health care. I think that we aim at an added 5 years in good health for every person by 2030. Empowering patients is of great importance within that target, as is diversity in outlook. Do our trials benefit the entire population in the Netherlands? And are all citizens involved or is it only a certain part of the population that will benefit from health initiatives, personalized medicines and foster development?

Going back to your first question on the responsibilities of CCMO: our main role is to protect all ?trial participants, ranging from healthy volunteers in early trials to patients in later stage trials, involving pregnant women, children, incapacitated patients and trials with medicines, medical devices, treatment comparisons and psychological tests. Every trial participant has the right to protection. But we look beyond our legal tasks: e.g. we would like to contribute to stimulation of clinical research in the Netherlands and to improve patient participation in research, both leading to empowering patients in trials. We want to ensure patients are involved in the whole research cycle: from the trial concept up to the publication of trial results.

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Aida: And coming to you personally, could you tell us where your attention is focused on?

Stan: I have a passion for medicines and medical treatments from the regulatory perspective. I have always worked in this field. We have achieved much, e.g. if you look at pediatric oncology. CCMO paid a visit recently to the Princes Maxima Center for child oncology in Utrecht. In the late seventies every child with cancer died. Now, 50 years later, the majority of the children diagnosed with cancer leaves the hospital on foot. This kind of development is one of the reasons that we work in this particular domain of healthcare.

In my current role at CCMO, two things in particular appeal to me. Firstly, I carry the responsibility for almost 50 employees in this organization, making sure we join hands and we do our day-to-day’s work in the most efficient, transparent and effective way possible. And secondly, supporting participants and patients to improve their impact on the trial, good care and good information. Results should always be transparent and public. I believe that more patient input ensures improved trials and improved outcomes.

It was only when I started working for CCMO that I realized, that we have some 300,000 participants (both healthy volunteers and patients) each year in clinical trials. And I don't think general public is aware that CCMO and the affiliated medical-ethical review committees (METC’s) ensure that participants in trials are protected. We, however, are doing our utmost to improve that awareness, among others by setting up a new trial register, which has just recently gone online (www.clinicaltrialregister.nl). It is a first version which we are improving on every day. The trial register is a platform where in future every person can find information on trials. It will include running trials, finished trials and, trials that are starting up. This means that people can enroll into those trials more easily than they can today. We want to make it also accessible for those inhabitants that are unable to speak Dutch or English. In two to three years, we expect this register to be an information hub for everyone living in the Netherlands.

Aida: That is a great achievement. Can you tell me what the greatest challenges are that CCMO faces?

Stan: The greatest challenge CCMO faces presently is, that under all new European legislation, like CTR, MDR and IVDR, we need to operate as a single country, not as an individual hospital, organization or association, and not as an individual ethics committee. This means that we need to strengthen the cooperation in the Netherlands between all stakeholders involved, from research organization to government, from innovative industry to CRO’s and academic to general hospitals. By strengthening that national role as a united country, we also have a better position in Europe. The Dutch Clinical Research Foundation (DCRF) is the basic platform we use to establish this national cooperation successfully.

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Aida: This is a critical point you mention as for achieving the envisioned future of health it is fundamental that the whole European health ecosystem is aligned, has the same mindset and even more so operating as one. However, CCMO is the Dutch regulator. What do you need to attain more influence and success in the objectives you have?

Stan: The stakeholders have a natural tendency to listen to the regulators. But at the same time, we all need each other. So as a regulator, we need to cooperate. So again, this is why then DCRF is of such major importance to us and to the stakeholders. We are looking for consensus jointly with the stakeholders, meeting them halfway if necessary.

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Aida: You talked about working towards a united country from a clinical trials perspective. How far are you in reaching that objective?

Stan: I think that we are well and truly on our way. One of the challenges facing us is that hospitals have their own responsibility for maintaining safety for participants in trials. And that is a huge responsibility. So the individual responsibilities from the different hospitals may clash in multicenter/multinational research. Consequently, if we stimulate uniformity and harmonization in assessing and performing clinical trials that would lead to more uniform approach as a country. I think we are on the right track!

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Aida: And what's the next step?

Stan: Deloitte and CCMO are jointly creating a strategic business plan for the next 5 years. This document, which we expect to be finalized in the first quarter of 2023, is crucial for our next steps in the direction we are going to take. It is going to be the basis for further discussions with the ministry and we will use it for creating the support base with stakeholders on several new initiatives we want to take.

Still, we have to remember, we are a very small organization, the strategic plan is ambitious and the timelines to success challenging. So, also in realizing targets of our plan, collaboration with our stakeholders is key.

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Aida: For me the key take away is that when we look at the future of health, it is fundamental that every single stakeholder in the ecosystem redefines the role they have to play and align the mindset. Thank you for telling us what CCMO is doing and the transformation that it wants to achieve.

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