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Fremtidens Kreftbehandling: Kreft og kliniske studier. Et veikart for bedre kreftbehandling.

Integrating clinical trials in cancer treatment

How can we make clinical trials an integrated part of cancer treatment in Norway so that more patients can gain access to new and better treatments?

We arranged a webinar with key experts and politicians to answer this question. Watch the entire webinar on Youtube:

“The number of patients that get considered to participate in clinical studies in Norway is too low and it is difficult to arrange clinical studies across borders in the Nordics. This is unacceptable, but how can we change it?” This is how the moderator Ketil Widerberg, general manager of Oslo Cancer Cluster, set the scene for our first webinar, which was live-streamed from Kreftforeningens Vitensenter in Oslo.

A visionary plan

The Norwegian Ministry of Health and Care Services has said that clinical studies should be an integrated part of patient treatment in Norway. This is especially relevant when it comes to the advent of new cancer treatments and the fact that the number of clinical trials is decreasing in Norway. The Ministry is now working on a Clinical Studies Action Plan to be completed in 2020.

Maiken Engelstad, Deputy Director General of The Department of Specialist Health Care Services, gave a presentation on its contents so far. An overarching goal is to get more, useful clinical studies to Norway, so that more patients can receive better treatments, and ultimately achieve a more efficient health service.

Engelstad mentioned many important aspects to achieve this. For example, to create more collaborations between the industry and public sector, with NorCRIN as a “one-stop-shop” for clinical studies. Engelstad stressed that Norway needs to build capacity, so that feasibility, recruitment and approval is accelerated. Engelstad also talked about building competency, by including clinical research, gene therapy and artificial intelligence in education. Moreover, Engelstad wants to increase the multitude of different studies, catering to both big and small patient groups, vulnerable patients, assessing both new and established treatments, and conducting the trials both locally, nationally and internationally. 

“We need to look to Norway’s advantages, such as real world data, which can be used from designing the drugs to implementing new therapies in the clinic.” Maiken Engelstad

Engelstad said that there needs to be a national and regional framework in place to achieve this, with regulations, financing, infrastructure and competency. Engelstad finally highlighted that one of the biggest challenges is to achieve a cultural change towards conducting clinical trials in Norway.

The tangle of rules

The legal framework that regulates clinical studies in the Nordics is very difficult to navigate for patients who wish to participate in and for companies that wish to arrange clinical trials. Wenche Reed, Head of Research in The Section for Research, Innovation and Education at Oslo University Hospital, talked about how complicated it is to interpret the regulations. 

“There are many laws to consider when conducting clinical studies. It is not easy to navigate the legal landscape – not even for lawyers!” Wenche Reed

Reed explained that the advent of personalized medicine in cancer is challenging the division between patient treatment and clinical research. Moreover, the ethical and legal framework for handling big data is being challenged, because of new developments using artificial intelligence in diagnostics.

Tearing down the barriers

The introductory presentations were followed by a lively panel discussion, divided into three sections. The first section included a video message from Tone Skår, project manager in VIS Innovation and founder of the MED.hjelper project and #SpørOmKliniskeStudier social media movement. Skår emphasised the importance of informing patients of the possibility of participating in trials and creating incentives for doctors and hospitals to run the trials.

Sigrid Bratlie, Special Adviser in The Norwegian Cancer Society, commented that a cultural change is needed. Bratlie said we need to look at concrete cases to learn how to conduct successful clinical studies in cancer personalised medicine.

Bratlie highlighted that Norway has world-class cancer research milieus, especially in cell therapy, but the total number of clinical trials is dwindling. Europe risks falling far behind the US and China, because of the complicated legal framework.

“The Biotechnology Act is just one small piece of the puzzle. Soon there will be a hearing for the Genetechnology Act. We need to look at the bigger picture and how the different laws interact.” Sigrid Bratlie

The second part of the panel conversation turned to both clinicians and industry for their perspectives. Daniel Heinrich, Senior Consultant Oncologist at Akershus University Hospital and Head of The Norwegian Oncology Association, wants to offer his patients the opportunity to try new treatments, which potentially can be better than the standard treatment. Heinrich highlighted that it is difficult for patients that need to travel to different hospitals and private clinics for testing because the hospitals lack capacity. He said that the directives need to come from above, from hospital management, the Directorate of Health and the politicians.

“It is almost impossible to include patients in studies in other countries now. Often it is difficult to understand why!” Daniel Heinrich

Baldur Sveinbjørnsson, Chief Scientific Officer in Norwegian cancer start-up Lytix Biopharma, has tried to arrange a clinical trial in Norway, but found that it was better to conduct it from a hospital in Copenhagen. When patient recruitment was too slow and costs were mounting every day, Sveinbjørnsson travelled around the Nordics to attract patients. There was great interest, but the differing regulations and processes in the Nordic countries put a stop to recruitment.

“We have started looking towards the US and filed an application to the authorities to conduct our next clinical study there.” Baldur Sveinbjørnsson

Hege Edvardsen, senior adviser in Legemiddelindustrien (LMI), thinks Norwegian companies should be able to conduct their trials in Norway. Edvardsen said we need to establish a “one-stop-shop” for clinical studies in Norway. Edvardsen said that the pharmaceutical industry often turns to the most successful cancer centres and hospitals when placing their clinical trials.

“Dedicated enthusiasts are the ones running the clinical studies, but we need targeted financing, so the people doing the work are acknowledged.” Hege Edvardsen

The final part of the panel discussion included two politicians’ visionary perspectives for the future.

Marianne Synnes Emblemsvåg, politician for The Conservative Party of Norway – Høyre, said she was touched by the ambitious plans in the Action Plan. Emblemsvåg commented that she is an impatient person, but that the bureaucratic process takes time to change.

“We need to market Norway in a way that makes us attractive for clinical trials.” Marianne Synnes Emblemsvåg

Emblemsvåg commented that there are many exciting developments considering artificial intelligence and diagnosing cancer, but that they come with some very challenging ethical considerations.

Tuva Moflag, politician for The Labour Party of Norway – Arbeiderpartiet, agreed that things take time to change. Moflag emphasised that part of the political work is to “clean up” some of the bureaucratic mess and to remove the legal barriers.

“We should have high ambitions for clinical studies, considering that we are a rich country and should assume responsibility for our patients.” Tuva Moflag

Moflag also stressed that there needs to be infrastructure, personnel and financing to complete it. Creating a culture of innovation, so that medical personnel feel they are part of something bigger than themselves.

The webinar ended with some final comments from Engelstad, who had been listening and taking diligent notes to bring with her in her work with the Action Plan going forward.

We want to direct a special thank you to all the meeting participants, to the organising partners and to everyone who followed the live stream.

Our next meeting in this series will take place this fall. More details will be published on our website closer to the event.

 

Event organisers:

OCC logo

Kreftforeningen logo

LMI logo

AstraZeneca logo

 

Janssen logo

MSD logo

 

 

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Debate from Arendalsuka

Together for precision medicine

During Arendalsuka 2019, we arranged a breakfast meeting on the development of cancer treatments of the future, together with LMI and Kreftforeningen.

Arendalsuka has become an important arena for those who want to improve aspects of Norwegian society. We were there this year to meet key players to accelerate the development of cancer treatments.

Our main event of the week was a collaboration with Legemiddelindustrien (LMI) and The Norwegian Cancer Society (Kreftforeningen). We wanted to highlight the cancer treatments of the future and whether Norway is equipped to keep up with the rapid developments in precision medicine. (Read a summary of the event in Norwegian on LMI’s website)

First speaker, Line Walen (LMI), presented the problems with the traditional system for approving new treatments in face of precision medicine.

The second presenter, Kjetil Taskén (Oslo University Hospital), introduced their new plan at Oslo University Hospital to implement precision medicine.

Then, Steinar Aamdal (University of Oslo) talked about what we can learn from Denmark when implementing precision medicine.

Lastly, Ole Aleksander Opdalshei (Norwegian Cancer Society) highlighted a new proposal for legislation from the government.

The exciting program was followed by a lively discussion between both politicians and cancer experts.

There was general agreement in the panel that developments are not happening fast enough and that the Norwegian health infrastructure and system for approving new treatments is not prepared to handle precision medicine, even though cancer patients need it immediately.

The panelists proposed some possible solutions:

  • Better collaboration and public-private partnerships between the health industry and the public health sector.
  • More resources to improve the infrastructure for clinical trials, with both staff, equipment and financial incentives.
  • Better use of the Norwegian health data registries.

After the debate, we interviewed a few of the participants and attendees. We asked: which concrete measures are needed for Norway to get going with precision medicine?

Watch the six-minute video below (in Norwegian) to find out what they said. (Turn up the sound)

 

Did you miss the meeting? View the whole video below on YouTube (in Norwegian).

 

Full list of participants:

  • Wenche Gerhardsen, Head of Communications, Oslo Cancer Cluster (Moderator)
  • Line Walen, Senior Adviser, LMI
  • Kjetil Taskén, director Institute for Cancer Research, Oslo University Hospital
  • Steinar Aamdal, professor emeritus, University of Oslo
  • Ole Aleksander Opdalshei, assisting general secretary, The Norwegian Cancer Society
  • Marianne Synnes (H), politician
  • Geir Jørgen Bekkevold (KrF), politician
  • Tuva Moflag (Ap), politician
  • Per Morten Sandset, vice principal for Innovation, University of Oslo
  • Audun Hågå, Director Norwegian Medicines Agency

 

Thank you to all participants and attendees!

The next event in this meeting series will take place in Oslo in the beginning of next year. More information will be posted closer to the event.

We hope to see you again!

 

Organisers:

 

 

 

 

 

Sponsors:

 

 

 

 

 

The panel at the breakfast meeting on the future of cancer treatments in Oslo.

Giving patients a stronger voice

How can the voices of cancer patients be heard when evaluating new methods of treatment?

A breakfast seminar was held yesterday in the series called The Cancer Treatments of the Future. Over 150 people attended at Litteraturhuset in Oslo, among them were relevant key players from the healthcare sector, governmental agencies, patient organisations and the public. The aim was to identify new opportunities to improve patient involvement when evaluating new methods of treatment.

The seminar was jointly arranged by Oslo Cancer Cluster, Legemiddelindustrin (LMI) and The Norwegian Cancer Society. The sponsors of the event were Astra Zeneca, Janssen and MSD.

 

Anne Grethe Erlandsen

Anne Grethe Erlandsen, the State Secretary of the Norwegian Ministry of Health and Care Services.

Anne Grethe Erlandsen, the State Secretary of the Norwegian Ministry of Health and Care Services, first talked about creating a healthcare service with the patient as the starting point. She said that it is important to involve the patient in the decision-making processes to bring in new perspectives, ask questions and challenge the healthcare service.

“The patient is the most radical agent of change in the healthcare sector.”
Anne Grethe Erlandsen

 

Ellen Nilsen

Ellen Nilsen, Special Adviser at Nye Metoder.

Next, Ellen Nilsen, Special Adviser at Nye Metoder, which is the national system for managed introduction of new health technologies within the specialist health service in Norway. Nilsen gave a presentation of Nye Metoder and its processes.

 “Anyone, including patients, their relatives or patient organisations, can submit a proposal for a new method of treatment.” Ellen Nilsen

The proposal is then managed by the regional health authorities in The Commissioning Forum, which commissions a full Health Technology Assessment (HTA) from The Norwegian Medicines Agency. Anyone can submit input to The Commissioning Forum by e-mail or in a form on the website.

Decisions are then made by the regional health authorities in The Decision Forum, based upon the HTA. Patient organisations are also represented in a reference group that meets every six months. The patient representatives are only observers, but have the right to make verbal contributions.

  • Learn more about Nye Metoder by reading this presentation in English from their official website.

 

Health Technology Assessment (HTA) is the evaluation of a new method of treatment, often in comparison to existing treatments. The treatments are assessed according to a set of criteria: the severity of the disease, the utility of the treatment and its cost effectiveness.

 

Anette Grøvan, Senior Adviser at The Norwegian Medicines Agency.

Anette Grøvan, Senior Adviser at The Norwegian Medicines Agency.

Then, Anette Grøvan, Senior Adviser at The Norwegian Medicines Agency, presented how they are developing a pilot project to involve patients in their HTAs. They have sporadically received input from patients and patient organisations in the past, but they wish to implement a better system for it now.

“Satisfied patients are important to us. Everyone should have a voice, regardless of their diagnosis or disease.” Anette Grøvan

They believe the patients can contribute with their experiences of living with the disease, the quality of existing treatments and their expectations on new treatments.

 

 

A panel discussion, moderated by Markus Moe, the Editor-in-Chief of Dagens Medisin, was then held with the following participants:

  • Tove Nakken, Head of brukerutvalget* at Oslo University Hospital and Deputy Head in Lymfekreftforeningen (The Norwegian Lymphoma Society)
  • Heidi Brorson, member of brukerutvalget* at the South-Eastern Norway Regional Health Authority and Special Adviser in the Norwegian Cancer Society
  • Anette Grøvan, Senior Adviser at The Norwegian Medicines Agency
  • Jan Frich, Chief Medical Officer at the South-Eastern Norway Regional Health Authority and Senior Adviser in the Commissioning Forum
  • Odd Terje Brustugun, oncologist at Drammen Hospital

*”brukerutvalget” is a selected group of patient representatives that exists in each regional health authority

 

Panel discussion at the breakfast meeting about the future of cancer treatments.

The topic of the panel discussion was how to improve patient involvement when evaluating and approving new methods of treatment.

 

Nakken first highlighted the lengthy processes in Norway: “Patients want to take part of the treatments that have been approved in our neighbouring countries. But the bureaucracy in Norway takes too long.”

Brustugun agreed that there is a gap between the treatments available in Norway and abroad, and that this is affecting an ever-growing patient population: “The patient’s perspective is important, because there is a large group of patients that can potentially become long-term survivors if given the new treatments.”

Frich said the overall cost of pharmaceuticals in Norway has actually increased over the years, mostly due to new and expensive cancer therapies. He explained they are legally obliged by Stortinget to evaluate new methods according to a specific set of criteria. The reason that a treatment isn’t approved may be that the effect of it has not been documented well enough.

Brorson called for greater transparency in the decision-making processes: “If there was more openness about the decision-making, the patients would have a greater understanding for it and become better informed.”

Grøvan added: “We are not finished developing the system for patient involvement and there are a lot of considerations to make sure that it becomes structured and fair.”

 

The audience at the breakfast meeting on the future of cancer treatments.

The engaging panel discussion inspired the audience to make their own comments and reflections.

 

The fruitful discussion led to many constructive ideas on how to improve patient involvement. Hopefully, these kinds of collaborative discussions can inform politicians to take the necessary steps forward to improve cancer patients’ lives.

Oslo Cancer Cluster wants to thank the speakers, the sponsors, the organisers and everyone who attended! This discussion will continue at Arendalsuken 2019, at our event August 15. We hope to see you there!

 

  • Here is a summary of the event, written in Norwegian, from LMI’s official website.

Can Norway compete internationally on health?

Can Norway take a leading international position within the health industry? This was the main question for one of our discussions at Arendalsuka last week.

A report released in April this year shows a Norwegian health industry on the rise. However internationally, Norway is still comparatively small even compared to our Nordic neighbors.

SEE VIDEO FROM THE MEETING (Facebook, in Norwegian)

See our other events during Arendaluka:

  1. Fremtidens kreftbehandling i Arendal (In Norwegian)
  2. Tim: Pasienten som kommer hjem (In Norwegian)

Feasibility study
Oslo Cancer Cluster, Norway Health Tech, LMI, Innovation Norway and the The Research Council of Norway have, based on the ambition of creating a profitable health industry in Norway, conducted a feasibility study regarding the strategical positioning of the Norwegian health industry. 30 key position holders within the industry have contributed to the report, giving their views on how Norway can build a stronger health industry.

READ THE REPORT

The event in Arendal featured a a debate panel consisting of Ketil Widerberg from Oslo Cancer Cluster, Kathrine Myhre from Norway Health Tech, Monica Larsen from Legemiddelindustriforeningen, Hans Eirik Melandsø from Innovasjon Norge and Anne Kjersti Fahlvik from The Research Council of Norway.

Collaboration key
Collaboration between public institutions and the innovative private sector is important to create a health industry of some size, both according to the report published in April and the participants in the Arendal-panel. Oslo Cancer Cluster facilitates this kind of innovative public-private collaboration.

– We represent the whole value chain when it comes to cancer treatment and innovation. Research institutions, hospitals, as well as both small and large companies, Ketil Widerberg explained.

One example of how Oslo Cancer Cluster contributes to a functioning health industry is the new Car-T cancer treatment developed by Novartis. Important research and treatment conducted by the department of cell therapy at the Radium hospital is funded for clinical studies by the pharmaceutical company Novartis, the production is made possible by Norwegian innovations from Thermo Fischer, while the Norwegian Medicines Agency works hard securing international treatment approval.

– This type of collaboration saves lives while creating employment and income, said Widerberg.

Three ways to recreate success
The question is how do we recreate these type of success stories, and Widerberg emphasized three different aspects: More clinical studies, releasing the shackles on our health data and cultivating high-end research.

– Today, a successful Norwegian Centre of Excellence loses it’s funding after 10 years. If the research is a success, it should be doubled, he said.