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Today’s trials, tomorrow’s health

There are so many benefits for patients and society, but also for the healthcare itself, from performing clinical trials. So why are the sponsor initiated trials so hard to bring about?

And how come that lack of resources is the most common reason for not performing clinical trials, when the clinic is more than well compensated for the cost of the trial from the sponsor? These questions were addressed at a seminar hosted by SwedenBIO during the Almedalen week in Visby 2022.

“These questions were addressed at a seminar hosted by SwedenBIO during the Almedalen week in Visby 2022.”

Values and challenges with sponsor initiated clinical trials

On the theme “Today’s trials, tomorrow’s health” the seminar illuminated the values and challenges with sponsor initiated clinical trials.

Clinical trials are a prerequisite for new therapies to reach patients. Through performance of, and participation in, studies the patient can be an early adopter of the latest state of the art treatments, and they are of course necessary for the development and introduction of new innovative therapies for the many patients. But there are also a causal and intricate relation where development and introduction of new therapies are a prerequisite for development of the next generation of treatments. Without clinical trials and introduction of new therapies, there will be no more trials and that is where the development-journey stops!

“In other words, it is extremely important that we implement the results from our research activities. If we do not use the modern innovative therapies in our healthcare, we can’t conduct clinical trials. The spiral effect can quickly turn downward.”

If trials are not conducted in healthcare, the clinic will lack knowhow for the next generation of research and development. And, if the clinic does not use the latest standard of care treatment, the patient has not got the right comparative treatment for the studies and are ruled out from performing further studies. In other words, it is extremely important that we implement the results from our research activities. If we do not use the modern innovative therapies in our healthcare, we can’t conduct clinical trials. The spiral effect can quickly turn downward.

 

Karin Meyer, PhD, CEO of the Center for Translational Research Sweden, Mantas Okas, Physician, Capio Sankt Görans hospital, Frida Lawenius, Deputy Director General, SwedenBIO and Marie Morell, (M), Chair of SKR’s healthcare delegation, regionråd Region Östergötland

 

Looking for places where they can perform high quality studies

The companies scouting for were to conduct their trials and research activities are looking for places where they can build a strong and competitive knowhow environment, where they can perform high quality studies. Sweden and the Nordics are known to be good to work in and there is an interest from the companies to build a strong environment for research activities here.’

“For five planned trials in the first quarter of 2019 resp 2021, 27 sites were contacted. 16 turned down the proposal due to lack of resources and the result were two studies initiated at two sites.”

So what’s the status today? Sweden and the Nordics are proud life science nations with flourishing research, innovation and industry and national treasures such as health data. Suzanne Håkansson, Senior Director Government Affairs, AstraZeneca, gave an example from AstraZeneca’s studies on lung cancer. For five planned trials in the first quarter of 2019 resp 2021, 27 sites were contacted. 16 turned down the proposal due to lack of resources and the result were two studies initiated at two sites.

Obstacles

Recurring is the lack of resources. But the company sponsored trials pay all the cost associated with the treatments in the study and a fee to the clinic that more than well compensate for salaries and other costs, not to forget all the soft values such as enhanced knowledge, a stimulating and developing workplace and perceived better care from the patients. Copenhagen Economics finds in a study from 2019[1] that each clinical trial initiated by a pharmaceutical company improve the Swedish GDP with one million SEK and the public budget with 0.9 million.

“Each clinical trial initiated by a pharmaceutical company improve the Swedish GDP with one million SEK and the public budget with 0.9 million.”

Despite resources on an aggregated level, the scarce and stressful situation is very much a reality for the clinic. With no procurement for research and no scheduled research activities, the time the clinician spend on research are perceived as “off for research”. A slim staffing, with no slack or resources to cover up for colleagues participating in studies, makes it hard for the superiors to make the decision to do without. And administration eat both care and development for breakfast. Another obstacle is that the same budget cover both staff and treatment, no need to emphasize introduction of modern and innovative therapies and leaves the clinic to choose between staff or pharmaceuticals. Focus on the postponed healthcare due to the pandemic makes it even harder to prioritize the postponed studies and research.

“In all, lack of driving forces, inefficiency and an incentive structure that hinder rather than promote research activities, makes studies hard to conduct irrespective of the overall economic resources and benefits.”

In all, lack of driving forces, inefficiency and an incentive structure that hinder rather than promote research activities, makes studies hard to conduct irrespective of the overall economic resources and benefits.

Think out of the public healthcare box

For an alternative the companies turn to the clinical research organizations. According to Karin Meyer, CEO of the CTR-group, they have more inquiries about patient studies than ever before. In an ambition to be a part of the solution and to reduce the pressure on the public healthcare system, they built up their own clinical trial sites next to the hospitals, with staff, equipment and processes in place, and modern it-solutions for more virtual trials.

“A one-stop-shop for the clinician with the deep expertise in the therapeutic area to come to.”

A one-stop-shop for the clinician with the deep expertise in the therapeutic area to come to. And this is only one example of how we can think out of the public healthcare box to fill the gaps in the research – innovation – introduction -loop, that constitutes the holistic structure that needs to be in place to be an attractive and sustainable life science nation.

Endurance and patients

Beside the holistic perspective and recognition of the causality, what is needed is endurance. Long-term conditions with a clear mandate for the clinics to build a stable foundation and to employ for both care and research and with procurement for research and development where time and money dedicated for research activities are purchased. There must be incentives for research activities and the use of health data must be solved.

“It is not good enough when there is no chance for an innovative product to submit a tender and get business in the region where it has been developed, when they instead should lead by example.”

Last, but not least, without patients no studies. We must make sure that patients can participate in clinical studies even if they do not live next to a research hospital. And we need pricing models and procurement processes that make it possible for the patients get the new therapies. It is not good enough when there is no chance for an innovative product to submit a tender and get business in the region where it has been developed, when they instead should lead by example.

“We all need to do our bit and we need to do it together – companies, hospitals, politicians and patients, and to prioritize clinical research and development if we want a sustainable healthcare for the generations to come.”

Hard as it can be to change a public healthcare system, creative and alternative solutions to ease the pressure on the healthcare system are needed along the way, with study sites or provision of skills such as study coordinators. We all need to do our bit and we need to do it together – companies, hospitals, politicians and patients, and to prioritize clinical research and development if we want a sustainable healthcare for the generations to come.

Participants in the seminar

Jessica Lundström, Market Access Director, Bristol Myers Squibb, Suzanne Håkansson, Senior Director Government Affairs, AstraZeneca, Mantas Okas, Physician, Capio Sankt Görans sjukhus, Karin Meyer, CEO, CTR, Lise-lott Eriksson, Chairman Blodcancerförbundet, Marie Morell (M), Chairman SKRs healthcare delegation, Camilla Waltersson Grönvall (M) and Mikael Dahlqvist (S), Riksdagens socialutskott. Moderator: Frida Lawenius, Deputy director general, SwedenBIO

 

Karin Meyer, PhD, CEO of the Center for Translational Research Sweden, Mantas Okas, Physician, Capio Sankt Görans hospital and Frida Lawenius, Deputy Director General, SwedenBIO

 

[1] Det samhällsekonomiska värdet av företagsinitierade kliniska prövningar, Copenhagen Economics, Läkemedelsindustriföreningen 2019 01 10

Text by Frida Lawenius, Deputy Director General, SwedenBIO