Photo: Handlingsplan for kliniske studier, regjeringen.no

New political paper: Action Plan for Clinical Studies

illustrasjon av handlingsplan for kliniske studier

The Norwegian government wants to double the number of clinical studies by 2025, but is this goal ambitious enough?

The highly anticipated political paper “Action Plan for Clinical Studies (2021-2025)” was released in Norway by the Ministry of Health and Care Services this week. The government’s vision is to make clinical studies an integrated part of patient care.

A clinical study is a type of research study that tests how well new medical approaches, such as screening, prevention, diagnosis, or treatments, work in people.

The action plan is the first of its kind and has been requested by researchers, clinicians, the health industry and patient organisations for several years.

The number of clinical studies in Norway is on a negative, spiralling trend. This is especially alarming for cancer patients, who are eager to receive novel treatments.

The Norwegian Health Minister Bent Høie now sets the goal to double the number of clinical studies in Norway and include 5% of all patients in the specialist health services before 2025.

“The action plan includes many important points, we believe the bar should be raised higher,” commented Ketil Widerberg, general manager of Oslo Cancer Cluster.

“Our goal should be to make clinical studies available for all cancer patients in Norway – not just a small fraction.”

The government also announced in the State Budget proposal in October 2020 that NOK 30 million will be allocated through the NorTrials scheme. The funds will be used to employ study nurses and improve competency in clinical research.

The Norwegian Health Minister also calls for a change in work culture, in order to make clinical trials an integrated part of patient treatment.

Another major obstacle is the difficulty to recruit patients quickly. The regional health authorities are now tasked with developing a best practice for patient recruitment.

Oslo Cancer Cluster contributed input to the development of this political paper in September 2019. Our major suggestions included:

  • the need for financial incentives to improve patient recruitment,
  • establishing Norway and the Nordic countries as an international testbed for innovative medicine,
  • authorities to collaborate with industry on guidelines on how to approve precision medicine treatments and the documentation requirements.

Read our entire input here (in Norwegian): Innspill Kliniske Studier til Helse- og omsorgsdepartementet (September 2019) fra Oslo Cancer Cluster

 

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Dr Deborah Owen, Partner, Dehns, is looking forward to help Norwegian companies in the cancer field. Photo: Dehns

Dehns acquires Norwegian office

Dr Deborah Owen, Partner, Dehns. Photo: Dehns

Our member Dehns announced this week that the company will set up a local office in Oslo.

The law firm Dehns has acquired the Norwegian Intellectual Property consultancy firm Leogriff. This means Dehns will now have an active Norwegian presence with a local office in Oslo.

Dehns is a law firm specialized in patents and trademarks. Dehns’ attorneys have insight in many different technologies in the engineering, chemistry and biotechnology sectors.

With this acquisition, Dehns gains the highly-experienced Leogriff team with all their additional competencies, skills and expertise in Intellectual Property. Leogriff’s clients include companies, investors, research institutes and universities.

What does this mean for Norwegian companies in cancer innovation and life science?

“Companies in the cancer field and life science sector face many challenges and need an excellent network of advisors to navigate these successfully.”
Dr Deborah Owen, Partner, Dehns.

“Intellectual Property (IP) issues are key to such companies at all stages, and we are delighted that the opening of the Dehns’ Norwegian office provides an expansion of the Dehns’ team to provide even greater experience and expertise in areas relating to IP management and strategy consultancy, which will be of real benefit to Norwegian companies of all sizes in these sectors,” continued Owen.

Dehns was founded in 1920 and is one of Europe’s leading firms of patent and trademark attorneys. The company has more than 230 staff across 8 offices: London, Munich, Oxford, Brighton, Manchester, Bristol, Sandwich and, now, Oslo.

Dr Adrian Samuels, Partner, Dehns. Photo: Dehns

Dr Adrian Samuels, Partner, Dehns. Photo: Dehns

“We are delighted that, having been working closely with Norwegian innovators and industry leaders for over half a century, Dehns’ ongoing success will be supported by this direct investment in Norway.”
Adrian Samuels, Partner, Dehns.

For more information, please read Dehns’ press release or visit Dehns official website.

Carlos de Sousa, CEO of Ultimovacs, who has launched a new collaboration study in ovarian cancer with the Nordic Society of Gynaecological Oncology, the European Network of Gynaecological Oncological Trial Groups and AstraZeneca. Photo: Ultimovacs

New clinical study in ovarian cancer

Carlos de Sousa, CEO of Ultimovacs

Our member Ultimovacs has announced a new Phase II clinical trial for ovarian cancer patients.

DOVACC is a new clinical study from Ultimovacs that will investigate the effect of combining the cancer vaccine UV1 with a checkpoint inhibitor and a PARP inhibitor in patients with ovarian cancer.

This is the first time this type of combination treatment is tested in a clinical study. Patients with advanced ovarian cancer, who have relapsed after receiving two rounds of chemotherapy treatment are eligible for the study.

The study will be sponsored by the Nordic Society for Gynaecological Oncology – Clinical Trial Unit (NSGO-CTU). This group is a part of the European Network of Gynaecological Oncological Trial Groups (ENGOT), which is also a part of the study.

“The collaboration with the NSGO-CTU and ENGOT is exciting for us as they are very experienced with conducting clinical trials in the field of gynaecological oncology. Their expertise and network will support the recruitment of patients at multiple participating study sites across Europe,” commented Jens Bjørheim, Chief Medical Officer at Ultimovacs.

The global pharmaceutical company AstraZeneca, will contribute with two different cancer drugs to the study. These include the checkpoint inhibitor durvalumab and the PARP inhibitor Olaparib.

Ultimovacs is evaluating the company’s universal cancer vaccine UV1 and has also received NOK 10 million from Innovation Norway.

“A key benefit of UV1 is its safety profile, which enables a triple combination study with a PD-L1 inhibitor and now for the first time also with a PARP inhibitor, in an indication in desperate need of new treatment options,” commented Carlos de Sousa, CEO of Ultimovacs.

“The evaluation of UV1, durvalumab and olaparib in this Phase II triple combination study is an important next step in changing the standard of care for patients with ovarian cancer,” added Dr. Mansoor Raza Mirza, Medical Director of the NSGO-CTU and Chair of the ENGOT.

DOVACC is a randomised study, which will include 184 patients. The study is divided into three control arms, or patient groups. The first group includes 46 patients who will receive PARP inhibitor. The second group includes 46 patients who will receive both the PARP inhibitor and the checkpoint inhibitor. The third group includes 92 patients who will receive UV1 and both AstraZeneca drugs.

The multi-centre study will be held at more than 30 hospitals in about 10 countries in Europe.

The first patient will be recruited during the first half of 2021 and results are expected in 2023.

Ultimovacs currently have a broad clinical development programme, with over 500 patients enrolled in Phase II trials.

Read more in the press release from Ultimovacs

 

Jutta Heix, Head of International Affairs at Oslo Cancer Cluster and Project Manager of the new initiative CONNECT, which 22 public and private partners have joined to accelerate the implementation of precision medicine for Norwegian patients. Photo: Stig Jarnes/Oslo Cancer Cluster

Landmark public-private agreement for precision cancer medicine

Scroll down to read the press release in Norwegian.

While more than 30 000 Norwegians are diagnosed with cancer every year and the incidence is still increasing, more precise treatments can save lives. CONNECT is a new initiative aiming to ensure that precision medicine reaches the patients.

“A serious cancer disease is an existential challenge for the individual. Cancer research gives hope. The pharmaceutical industry and the public health sector, clinicians and executive authorities, have to collaborate to offer new treatments, balancing the latest research with hospital operations,” says Åsmund Flobak, Oncologist at St Olav’s Hospital, Trondheim University Hospital.

The new initiative, called CONNECT (Norwegian Precision Cancer Medicine Implementation Consortium), is a direct response to Health Minister Bent Høie’s political guidance to accelerate the implementation of precision medicine for Norwegian patients. It also responds to the Health Minister’s ambition to increase research and collaboration between public and private actors, including hospitals, other public stakeholders, the Norwegian Cancer Society, and the pharmaceutical industry.

CONNECT is one of four interconnected initiatives that will ensure infrastructure and collaboration on diagnostics, clinical trials, implementation of advanced precision medicine and use of health data e.g. for health economics analysis. This could eventually affect how Nye Metoder (The National System for Managed Introduction of New Health Technologies within the Specialist Health Service in Norway) is adapted for personalized medicine and treatments for small patient groups in cancer.

See the fact boxes about the different initiatives at the bottom of this page.

Precision medicine for the future

Precision medicine, or personalised medicine, is a type of treatment tailored to the individual patient based on individual diagnostic and clinical information. In simple words, it is about giving the right treatment to the right patient at the right time.

“The research front is continuously moving forward. With modern technology, today’s clinicians can analyse specific changes in the cancer of each patient. There are individual changes in a patient’s tumour that can be treated with targeted therapies tailored to every individual patient,” says Bjørn Tore Gjertsen, Director of Research at Haukeland University Hospital, Helse Bergen Health Trust.

“Precision medicine changes healthcare. The implementation of precision medicine requires new types of interactions and partnerships among patients, clinicians, companies, regulators, and payors. CONNECT is a new public-private partnership allowing all stakeholders to jointly address key obstacles and piloting novel solutions,“ says Jutta Heix, Project Manager for CONNECT and Head of International Affairs at Oslo Cancer Cluster.

A nationwide effort towards a common goal

CONNECT is a unique national partnership where the central players join forces to accelerate the implementation of precision medicine.

All six university hospitals in Norway are partners in CONNECT. More than ten leading pharmaceutical companies have joined the initiative so far. As representative for patients, the Norwegian Cancer Society will play a central role.

“We are also having a good dialogue with the Norwegian Directorate of Health, the Norwegian Institute of Public Health and the Norwegian Medicines Agency about participating in CONNECT and contributing with their competency. The Institute of Public Health joins as an observer from the start and the Directorate of Health has expressed an intention to join as an observer as well,” says Kjetil Tasken, Head and Director of the Institute for Cancer Research at Oslo University Hospital.

Karen Marie Ulshagen, Area Director at the Norwegian Medicines Agency, says in a comment that the Medicines Agency supports the project and intends to engage.

“A culture for public-private collaboration is not created through strategic plans, political ambitions or celebratory speeches, but through actions and behaviours that set a new standard. CONNECT is not about money or donating pharmaceuticals. It is the combined expertise of the different players and agencies that will increase the competency essential to ensure the implementation of precision medicine. Novartis is happy to participate, and I think that is true for the other industry players too,” says Lars Petter Strand, Head of Medical, Novartis Oncology Norway. He has worked closely together with representatives from Roche, BMS and Merck in the working group for CONNECT.

CONNECT and the associated public initiatives work towards common goals: giving patients access to medicines they otherwise wouldn’t receive, increasing the precision medicine experience of clinicians and researchers nationwide, generating data and insights important for analysing the outcomes and adopting health technology assessments for these new treatment concepts. Via CONNECT a structured dialogue, information sharing and planning for national precision medicine and diagnostics will be established, with Oslo Cancer Cluster having the coordinating role.

Unique public-private partnership

CONNECT will be an arena for all partners and stakeholders to address important issues and will ensure a balanced, broad, and informed approach and debate.

“This is a concrete and important milestone for public-private collaborations in the health sector and builds on the ambitions from, among other things, HelseOmsorg21. This is a completely new way to work in Norway and I hope it paves the way for more collaborative projects and pilots between private and public players in healthcare,” says Karita Bekkemellem, CEO of Legemiddelindustrien (LMI).

 

Press release in Norwegian:

Inngåelse av historisk offentlig-privat kreftsamarbeid

Mer enn 30 000 nordmenn diagnostiseres med kreft hvert år og antall krefttilfeller øker, mer presis behandling vil kunne redde liv. CONNECT er et nytt initiativ med mål å sørge for at presisjonsmedisin når pasientene.

– Alvorlig kreftsykdom er en eksistensiell utfordring for den enkelte. Kreftforskning er håp. Privat legemiddelindustri og offentlig helsevesen, både behandlere og overordnet byråkrati, må samarbeide for å kunne tilby ny behandling i grenseflaten mellom forskningsfront og sykehusdrift, sier Åsmund Flobak, lege ved Kreftklinikken St Olavs hospital.

Det nye initiativet, som kalles CONNECT, er en direkte respons til helseminister Bent Høies ønske om å akselerere implementering av presisjonsmedisin for norske pasienter. Det svarer også helseministerens ønske om mer forskning, og aktivt samarbeid mellom offentlige og private aktører som blant annet sykehus, andre offentlige interessehavere, Kreftforeningen og legemiddelindustrien.

Avtalen er en del av flere initiativ som vil sikre en infrastruktur og samarbeid for diagnostikk, kliniske studier, implementering av avansert presisjonsmedisin og bruk av helsedata til blant annet helseøkonomiske analyser. Dette vil etter hvert kunne påvirke hvordan systemet for Nye Metoder tilpasses persontilpasset medisin og behandlinger til små pasientgrupper innen kreftområdet.

Se faktaboks om de ulike initiativene nederst i saken.

Presisjonsmedisin for fremtiden

Presisjonsmedisin, eller persontilpasset behandling, er en form for kreftbehandling som er tilpasset spesielt den enkelte pasient. Kort fortalt handler dette om å gi riktig medisin til riktig pasient og til riktig tid.

– Forskningsfronten flytter seg stadig fremover, og med moderne teknologi kan leger i dag undersøke detaljerte forandringer i kreftsvulster hos hver enkelt pasient. Det finnes individuelle forandringer i arvestoffet som kan behandles med målrettede behandlinger som er tilpasset hvert enkelt individs behov sier Bjørn Tore Gjertsen, forskningssjef, Helse Bergen

– Presisjonsmedisin forandrer hele helsetjenesten og krever nye typer samarbeid og partnerskap mellom pasienter, klinikere, selskaper, regulatoriske myndigheter og betalere. CONNECT er et helt nytt offentlig-privat samarbeid som vil gi alle parter felles muligheter for å adressere utfordringer og prøve nye løsninger, sier Jutta Heix, prosjektleder for CONNECT og leder for internasjonal kontakt i Oslo Cancer Cluster.

Samler hele Norge for felles mål

CONNECT er et unikt partnerskap der alle de sentrale aktørene er samlet for å akselerere innføringen av presisjonsmedisin.

Alle seks universitetssykehus i Norge er med som partnere. Over ti ledende legemiddelselskaper har også gått med i initiativet. Som representant for pasientperspektivet er Kreftforeningen sentral.

– Vi har også hatt en god dialog med Helsedirektoratet, Folkehelseinstituttet og Legemiddelverket om å delta i CONNECT og bidra med sin kompetanse. Folkehelseinstituttet kommer inn som observatør fra starten, Helsedirektoratet har uttrykt en intensjon om å være med som observatør i CONNECT, sier Kjetil Tasken, leder for Institutt for Kreftforskning ved Oslo Universitetssykehus.

Karen Marie Ulshagen, Områdedirektør, SLV sier i en kommentar at Legemiddelverket støtter prosjektet og har en intensjon om en nærmere tilknytning dersom det er mulig.

– Kultur for offentlig-privat samhandling skapes ikke ved strategiske planer, politiske ambisjoner eller festtaler, kun gjennom handling og adferd som setter en ny standard. CONNECT handler ikke om penger eller donasjon av legemidler, det er den faglige ekspertisen fra de ulike aktører og instanser som utgjør kompetanseløftet som er essensielt for å sikre innføring av presisjonsmedisin. Novartis er glad for å kunne ta del i dette, og det tror jeg gjelder de andre industriaktørene også, sier Lars Petter Strand, Medisinsk Direktør i Novartis. Han har arbeidet tett sammen med representantene fra firmaene Roche, BMS, Merck i arbeidsgruppen for CONNECT.

Målet er at CONNECT og de underliggende initiativene sammen kan bidra til å gi pasienter tilgang til medisiner som de ikke ellers ville fått, helsepersonell og forskere får unik erfaring med denne type medisiner og diagnostikk, og helsevesenet vil få data og erfaring fra hvordan presisjonsmedisin fungerer og påvirker måten vi i dag regner helseøkonomi. Gjennom CONNECT skal det etableres strukturert dialog, kunnskapsutveksling og planlegging for persontilpasset medisin og diagnostikk hvor Oslo Cancer Cluster vil ha den koordinerende rollen.

Unikt offentlig-privat samarbeid

Alle medlemmer og interessenter vil kunne ta opp saker som er viktige for dem, da målet er at CONNECT blir en arena som sikrer en bred, balansert og informert debatt.

Dette er et konkret og viktig løft for offentlig-privat samarbeid på helsefeltet og bygger videre på ambisjonene fra blant annet HelseOmsorg21-rådet. Det er en helt ny måte å jobbe på i Norge og jeg håper det baner vei for flere samarbeidsprosjekter og piloter mellom private og offentlige helseaktører, sier Karita Bekkemellem, Administrerende direktør i Legemiddelindustrien (LMI).

 

Fact boxes:

InPreD (Infrastructure for Precision Diagnostics) is a national infrastructure for advanced molecular diagnostics that will secure a robust, interactive structure facilitating clinical cancer trials on a national level by providing equal access for patients to advanced diagnostics, state-of-the art competence and technology.
IMPRESS-Norway (Improving public cancer care by implementing Precision medicine in Norway) is a prospective, non-randomized clinical trial evaluating efficacy of commercially available, anti-cancer drugs prescribed for patients with advanced cancer diagnosed with potentially actionable alterations as revealed by standardized molecular diagnostics. IMPRESS-Norway is a nation-wide study and all hospitals with an oncology and / or hematology department will be invited to participate in the study. As of December 2020, 17 Norwegian Hospitals have agreed to join IMPRESs. The study will use a combined umbrella and basket design and a Simon two-stage model of expanding cohorts to follow up potentially effective combinations of biomarker and drug on specific indications. Sampling of biological material will be performed at presentation, during treatment and upon progression. Additional biomarker and translational analyses including whole genome sequencing (WGS) on tumour material and liquid biopsies, identifying mechanisms underlying drug sensitivity versus resistance will be performed.
INSIGHT (Regulatory framework for implementing precision medicine into the Norwegian health care system) will develop an analytic framework for using synthetic control data for evaluating effects of small-scale one-armed clinical trials, as in IMPRESS-Norway. INSIGHT will use the developed control arms and data from IMPRESS-Norway and InPreD to evaluate cost-effectiveness of the PCM-model and suggest new reimbursement scheme that reflects the uncertainty in PCM. Concrete ethical and legal challenges when integrating clinical research as part of standard-of-care e.g. the need for informed consent, access and data sharing, storage of molecular data as part of diagnostic pipeline will also be addressed. Taken together, the project will deliver fundamental knowledge and suggest regulatory changes/models necessary for implementation of PCM.

 

CONNECT Founding Partners:

  • Akershus universitetssykehus HF
  • Helse Bergen HF
  • Helse Stavanger HF
  • Olavs hospital HF
  • Universitetssykehuset Nord-Norge HF
  • Oslo Universitetssykehus med Kreftregisteret og OUH Comprehensive Cancer Center
  • Folkehelseinstituttet
  • Oslo Cancer Cluster SA
  • Kreftforeningen
  • Legemiddelindustrien
  • Roche Norge AS
  • Bristol-Myers Squibb Norway Ltd NUF
  • Novartis Norge AS
  • Merck AB NUF
  • Takeda AS
  • Amgen AB Norge NUF
  • AstraZeneca AS
  • AbbVie AS
  • Bayer AS
  • PubGene AS
  • Pfizer Norge AS
  • NEC Corporation