Det antages ofte, at patienterne per definition har gavn af at få tilbudt nye produkter, behandlinger osv. At de sågar lider under langsom ibrugtagning af nye produkter i sundhedsvæsnet.
Det er dog ikke tilfældet. Det er veldokumenteret, at overdiagnostik og overbehandling er et udtalt problem i mange sundhedsvæsner. Det udgør et patientsikkerhedsmæssigt, økonomisk og etisk problem.
Derfor skal en europæisk life science-strategi facilitere mere og bedre klinisk forskning. Vi har brug for at finde ud af, hvilke produkter patienterne har gavn af.
Det er ikke bæredygtigt at blive ved med at lægge nye varer på hylderne. Derfor er det nødvendigt også at teste eksisterende behandlinger, produkter osv. LVS mener ikke, at man kan bruge en life science-strategi til noget uden at tage sundhedsvæsenets generelle problemstillinger i betragtning.
LVS foreslår derfor, at en europæisk life science-strategi indeholder:
- Udbredelse af platformsforsøg.
- Involvering af patienter og pårørende i alle former for evaluering af sundhedsydelser.
- Choosing Wisely – i Danmark Vælg Klogt, som tilbyder at identificere og bistå med at de-implementere unødige behandlinger. Et arbejde baseret på et ligeværdigt samarbejde mellem læger og patienter.
- Finansiering af klinisk forskning for at tage højde for den ulighed, der findes mellem patientgrupper og sygdomsområder.
LVS bidrag til en europæisk life science-strategi:
The Organization of Danish Medical Societies (LVS) is honored to participate in a Danish contribution to a European life science strategy.
The very first consideration of a life science strategy is to be mindful of patient safety and patient benefit. This applies to all stages of the patients’ journey through the healthcare system from the diagnostic process to treatment, care, and follow-up.
Patient benefit is often mistakenly taken for granted with regards to new treatments and products. However, it is well documented that overdiagnosis and overtreatment constitute challenges to many health care systems. This is not only a costly problem. It also poses significant risks to patients, and it exacerbates inequity in health.
European health care systems are under pressure from demographic factors, economic restraints, and a shortage of healthcare personnel. This means that there is no room for spending time and money on products that are not demonstrably beneficial to patients and worth the investment.
Arguably, products that have been tested and can be marketed as tested and found to be beneficial to patients would be a commercial benefit to Danish and European life science companies as well as an ethical advantage.
Therefore, LVS strongly supports measures that facilitate more and better clinical research across the EU, including in Denmark.
We need to improve clinical research close to and together with the patients that facilitates:
• Testing new treatments, procedures, and examinations before they are introduced on a large scale into the health care systems.
If evidence of benefit is identified early, it will save time and money for the healthcare system as well as the life science companies.
If the product fails in tests; health care systems and companies can move on quickly and redirect their efforts.
The benefit for patients is obvious.
• Testing established treatments, procedures, and examinations.
Adding on to treatments, procedures and examinations in the Danish and European healthcare systems indefinitely is not sustainable for patients (burden and safety), economies, and the climate.
There is an urgent need for a universal evaluation of what we offer patients and spend time and money on in our health care systems.
Good clinical research with stakeholder involvement embedded in all parts of health care is the tool for a systematic evaluation of what we do.
The Danish Choosing Wisely organization (Vælg Klogt) is established as a unique cooperation model where Danish Patients organization and LVS work together to avoid the unnecessary in the Danish Health care system. Employing this unique cooperation model across Europe is highly recommended.
As an example, measures that will facilitate the necessary changes in the Danish health care system include:
• Providing a budget that follows clinical activities. Money for clinical research should follow the patients and facilitate collaborative networks of clinical academics.
Inadequate funding for clinical research is a major barrier for clinical research. Too much time is spent on searching for funding that should have been spent on doing clinical research.
The lack of funding for patient groups and illnesses that presently do not attract commercial interest leads to underdeveloped clinical research environments. This is a major ethical issue in Danish and European health care as well as highly unfortunate for patients, the health care system, and the effort to minimize inequity in health.
It also represents missed opportunities for public-private partnerships in these areas. Private partners need a robust and predictable public clinical research set-up, particularly when it comes to partnerships with life science startups.
• Establishing strong methods centers close to clinical activities. The aim is to facilitate high quality diagnostic studies, clinical trials, and stakeholder involvement.
The COVID-pandemic demonstrated that good, collaborative research can rapidly improve diagnostics and treatments.1 Building on these experiences, hospitals in the EU are currently building common, lasting research structures, e.g., platform trials, but these efforts rely on enthusiast in selected areas, and they are uncoordinated and massively underfunded.
Denmark and the EU should aim at being world leading in developing and employing common lasting and readily available structures for collaborative diagnostic studies and advanced clinical trials (e.g., platform trials) together with all relevant stakeholders, including patients and industry.
This will benefit all and reduce waste, overdiagnosis, overtreatment and inequality.
• Investing in permanent digital infrastructure close to clinical activities and patients for clinical work and clinical research.
There is no time to waste when it comes to taking advantage of digital developments and using them to improve Danish and European clinical work and clinical research.
A digital infrastructure, including advanced modelling, built near the electronic health care records will facilitate clinical use (e.g., patient-like-me solutions and algorithm based decision support) and clinical research (developing and improving these tools and supporting diagnostic studies and advanced clinical trials).
Establishing common data models (structure and content) and platforms for federated analyses will enable immediate access to large sets of live patient data without having to move data – they stay where they have been generated by the various sources (e.g., the servers behind the electronic health record systems). There are currently efforts in several places to establish common data models (e.g., OMOP by academic groups and the Danish Medicines Agency), but it is necessary to ensure better coordination and funding.
• Establishing the legal framework that supports the integration of clinical work and clinical research.
This has been on the top of the wish list for a long time and must be realized now.
• Reducing the bureaucratic burden for collaborative clinical research.
The research that does change clinical practice is often collaborative including patients across several countries, because this increases the likelihood of benefit in more health care systems. For the industry, multinational clinical trials are often a regulatory requirement to get marked access.
It is, however, a problem for academic researchers and industry who want to do clinical research across several European countries (e.g., a European clinical trial) that the workload with ethical approvals, contracts, data transfer agreements, and insurances is massive and hence very time consuming and costly.
Ironically, these massive efforts add little quality to the research once the first ethical approvals have been obtained. But they do delay and even prevent improvements in patient treatment and care in Europe.
All reductions in the bureaucratic burden for collaborative clinical research done by academia and industry will benefit European patients, health care systems, clinical researchers, and the life science industry. If done broadly, the benefits would be huge and the risks low, at least on the academic side.
• Benefit for disadvantaged patient groups.
As always, Denmark and the EU should work proactively to ensure that these technologies also benefit disadvantaged patient groups and contribute to minimizing health care inequity.
1 https://www.recoverytrial.net/