How do we ensure that clinical studies are based on the needs and prerequisites of patients, and is it a right for patients to take part in clinical studies? This issue was discussed during a seminar in Almedalen on 5 July.
The seminar was introduced by the Swedish Research Council’s Director-General, Sven Stafström, who described the Research Council’s mandate within clinical studies.
The Swedish Research Council was formed in 2001, and in 2005 it was made responsible for the financing and long-term planning of national research infrastructure. In 2013, it was mandated to improve access to registers and facilitate the use of register data in research. In 2014, the Research Council was given a mandate to support and develop the prerequisites for clinical studies, where an important part of the work is to create collaboration with and between Sweden’s healthcare regions. The Swedish Research Council collaborates with the healthcare regions in several ways, for example through the Committee for Clinical Therapy Research and in conjunction with the assignment to evaluate the ALF agreements.
The mandate linked to Clinical Studies Sweden concerns making Sweden an attractive country for locating studies. Patient commitment plays an important part in this.
“Almedalen is a natural place for discussing challenges that healthcare and politics must solve together.”
Håkan Billig, chair of the Committee for Clinical Studies, established that healthcare has changed as patients have changed from being passive to active participants, but that as far as research is concerned, there still exists great development opportunities in terms of patient involvement 1.
Håkan Billig also shared the result of two articles pointing to the importance of research for increased quality in healthcare 2,3.
“An article published in the BMJ looked at 33 studies, of which 28 found that the quality of healthcare increased at the units taking part. Another study showed that mortality had decreased in the units that conducted clinical studies. At the same time, we know that the opportunities vary for patients to take part in research in Sweden today.”
There are laws and directives that indicate patient participation. Funding bodies have also started to notice the importance of patient participation. One example is the Swedish Research Council’s calls within therapy research. Håkan is convinced that other funding bodies will also impose similar requirements for this within the near future.
“There exists a wish to involve patients, and there are no legal or political obstacles to this. The question is not when or if, but rather how this is to be done.”
Håkan also pointed out that, just as for the British NHS, there are advantages if those who will be using the results that impact on the operation are included when prioritising and financing research.
“County councils and regions need to be part of prioritising resources for research, based on operational needs. The need for collaboration and collaboration itself is everybody’s responsibility.”
Susanna Axelsson, Director-General of the Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU), describes how SBU summarises published research to provide answers to important clinical questions. A large proportion of the studies reviewed are not relevant.
“A British article published in The Lancet indicated that 85% of health research is wasted 4. Why is this? Well, it is because the research question is not relevant to the person it relates to, that is to say the patient. For example, within knee joint arthritis, there is masses of research into medicines. But when the patients were asked, it turned out that what they wanted to know more about was surgical treatment and continuing advice.”
Susanna emphasises that user influence is needed in research.
“We can see that there are gaps in knowledge. The question is, how should we prioritise? How do we spend money on things that are beneficial, and that make a difference?”
Jonas Andersson, chair of the Healthcare Board in Västra Götaland Region, established that in Sweden, we are good at finding gaps in knowledge and research questions, but that we must get better at creating benefits in healthcare based on this knowledge.
“We must also get better at cooperating in Sweden. We cannot have the Västra Götaland Region competing with Skåne; we must be able to cooperate. There cannot be a winner and a loser; all must be part of it. Clinical studies are one of the keys to better quality in healthcare, but unfortunately they are not prioritised in the everyday work. Within the Västra Götaland Region, we are trying to engage primary care in clinical studies and on finding a better model for increased commitment and more studies.”
Sara Riggare was diagnosed with Parkinson’s disease 14 years ago. Sara is a doctoral student within digital self-care at Karolinska Institutet, and is using her academic knowledge to help patients understand what researchers are actually writing, that is to say she interprets the academic language. On average, Sara sees her own doctors for two hours per year, but estimates that she spends more than 8 000 hours per year on self-care.
“There is a lot of knowledge to be learnt from patients, and many patients want to contribute. It is also a right to contribute to your own future and to have the opportunity to see the results of the research you participate in.”
Together with a large number of parties, both patients and researchers, and with a grant from Vinnova, Sara is carrying out a project to develop the concept of leading-edge patient.
To conclude, all panel members were asked the question: “What is the most important factor for having more clinical studies on patients’ terms?”
Picture, from left to right: Helena Bornholm, Susanna Axelsson, Jonas Andersson, Håkan Billig, Sara Riggare
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