Photo: Shutterstock.

Senior consultant Thrasyvoulos Tzellos in Harstad is national coordinator for several trials on skin conditions. Over the past three years, the skin disease research community at the University Hospital of North Norway (UNN Harstad and UNN Tromsø) have built up sound expertise in clinical trials.

The result of this focus on clinical trials is satisfied patients and greater staff expertise.

‘Our patients have used pretty much every medication going and nothing has worked. In these trials, they get the opportunity to test brand new biological drugs for atopic eczema. There has been a great deal of interest from patients, and we haven’t been able to include everyone who has wanted to participate,’ says Tzellos.

In the global clinical trial referred to here by the dermatologist, Harstad, Tromsø, Bergen and Oslo have recruited almost as many patients as Japan and the USA, among the 30 countries taking part across the world.

The senior consultant is based in Harstad and cooperates closely with the expert skin disease research communities at UNN Tromsø, Oslo University Hospital and Bergen University Hospital on the atopic eczema trial. He has long experience of participating in clinical trials from his native country Greece, and from Germany.

Impressive efforts in the North

Siri Kolle is responsible for clinical trials at Inven2, and is impressed by the work of Tzellos and his colleagues.

‘The skin disease research community at UNN Harstad and Tromsø have expertise, a good patient base and deliver on trials commissioned by the industry. This shows that Norway can also attract clinical trials in this field of therapy. We find it particularly pleasing to see that UNN is flexing its muscles in clinical trials, as there is a great deal of potential for more trials at the hospital, and it is important to show that we have clinical trial competence throughout Norway,’ says Kolle.

Inven2 has negotiated a contract with AbbVie and the other pharmaceutical and med-tech companies that run trials at the hospital, on behalf of the University Hospital of North Norway (UNN). Inven2 is also responsible for financial follow-up while the trials are in progress.

‘Our role is to organise all the legal, contractual and financial aspects of clinical trials on behalf of UNN in such a way that we contribute to making it an attractive partner for industry,’ says Kolle.

Moving in the right direction

Tzellos thinks Norway is moving in the right direction with respect to clinical trials.

‘It is also important that everyone is moving in the same direction and wants to see more clinical trials taking place in Norway, from the Ministry of Health and Care Services to hospital management, patients and expert communities. There is now a shared understanding that clinical trials are good for patients and for hospital finances,’ says Tzellos.

Tzellos also thinks we must start competing for clinical trials with our neighbouring countries.

‘The pharmaceutical companies are obliged to carry out clinical trials of new treatments. It is extremely important that such trials are conducted in Norway, and not just in Sweden and Denmark. Norway has a good reputation abroad and good electronic systems, the industry trusts us and the results we produce, and we have patients who want to participate in clinical trials. In other words, Norway has all it takes to become a lead player in clinical trials,’ says Tzellos.

Happy with the cooperation

The biopharmaceutical company AbbVie has one trial under way and another that is about to start in cooperation with, among others, UNN Harstad and UNN Tromsø.

‘Both are phase III trials on the use of biological drugs in patients with moderate to severe atopic eczema for whom other available treatment has not been effective,’ says Sissel Bondhus. She is responsible for these trials in Norway on behalf of AbbVie.

One of the trials is what is known as a register study, which is important as the results are vital to whether AbbVie can apply for a marketing permit or not for this indication.

‘The cooperation with Tzellos and his colleagues has been excellent. Setting up a clinical trial is very complicated. It’s not just a matter of cooperating with the key personnel involved in the trial, but also with the lab, pharmacy and others at the hospital. Tzellos has the advantage that he has international experience of trials and therefore understands what is important when you are participating in a clinical trial,’ says Bondhus.

A speedy start-up and the inclusion of patients within the stipulated deadlines are important to pharmaceutical companies when they are set to test new drugs. And Harstad and Tromsø have proven to be world-class in the trial they are currently running.

‘We definitely want to continue our collaboration with this research community as it runs very smoothly. Running trials is expensive so it’s important that the hospitals have both the resources and patients needed. We are a small country in a global context and we compete with other countries for interesting trials. We must therefore show that we deliver on both quality and patient numbers,’ says Bondhus.

Testing biological drugs

Thrasyvoulos Tzellos (UNN Harstad) and Øystein Grimstad (UNN Tromsø) are involved in phase II and III trials on biological treatments for chronic skin diseases.

‘The biological treatments represent much of the future for skin diseases, cancer and rheumatic conditions. The clinical trials are not available to patients until they have tried many other systematic treatments without effect. We run double-blinded, randomised trials where neither we nor the patients know who is given the medicine and who is given the placebo,’ says Tzellos.

Capacity is currently overwhelmed at Harstad and Tromsø, and we cannot take on more clinical trials.

‘One nurse is currently undergoing Good Clinical Practice (GCP) training, which will increase our capacity in the time ahead,’ says Tzellos. We would nonetheless like to see further investments so that clinical trials don’t have to be turned down. The skin disease research community at UNN Tromsø already has a very competent and engaged clinical research nurse.

‘I think Norway should introduce the same incentives as in England, the USA and other countries. There, trial personnel, doctors and nurses receive a small percentage of the revenue from the trial to compensate for the extra work and responsibility a trial entails,’ says Tzellos.

He is very conscious of his responsibility in connection with clinical trials, and often pops into the clinic to check the trial participants’ blood samples to ensure that all is well.

Read more:

https://www.pingvinavisa.no/sikrer-inntekter-og-faglig-utvikling-med-finansiert-forskning/

The post Conducting clinical trials on skin diseases – with flying colours appeared first on Inven2.

Photo: Shutterstock

After only four years of research studies, Akershus University Hospital (Ahus) is now able to offer patients participation in a total of 17 gastroenterology trials. The trials are mainly on Crohn’s disease and ulcerative colitis, two chronic inflammatory diseases of the bowel that can be very debilitating for those affected.

When they are not treating patients, Professor Jørgen Jahnsen, trial coordinator, and nurse Synnøve Louise Aure and their colleagues spend their working hours in a small terrace house beside Akershus University Hospital, where they can come together and work without interruption.

These people have a lot on their plate, which is no wonder since in the space of just four years, they have built a robust base for clinical trials in the field of gastroenterology. At least 17 trials are currently in progress, and Jahnsen is national coordinator for almost all of them. Synnøve keeps patients records and research protocols in order and cooperates with industry. They are run off their feet, but their reward is satisfied patients with Crohn’s disease and ulcerative colitis diagnoses.

‘They are young people, often the parents of little children, and it is important to be able to offer them treatment that enables them to go about their daily lives,’ says Aure.

The hospital’s catchment area totals around half a million people, which is 10 per cent of Norway’s population.

Few trials elsewhere in Norway

Ahus leads the field in gastroenterology trials in Norway, and conducts both researcher-initiated trials and trials on behalf of industry. They are currently also running two register studies. The enterprises they are conducting trials on behalf of are AbbVie, Boehringer Ingelheim, Celgene, Dr. Falk, Gilead, Roche and Takeda.

The trials at Ahus are mainly phase II and III trials, while phase I trials, which are highly experimental in nature, are not being conducted.

Jahnsen was recruited to work on clinical trials back in the 1980s, on gastric ulcers and reflux, which was how he became involved in trials in diseases that cause inflammation of the bowel.

‘It is exciting to lead the field and be able to offer something new to patients who are without other treatment options,’ says Jahnsen.

He says that there have been a lot of developments in the treatment of these diseases, particularly in the 2000s when biopharmaceuticals were introduced. Many new drugs have also been developed containing small molecules, known professionally as small molecules therapeutics. The advantage of these drugs is that they can be taken as tablets, which makes a great difference for the patients, as they no longer have to visit the hospital.

The research personnel are key

Jahnsen worked for 27 years at Aker Hospital. The medical clinic there had an outpatients unit with sufficient resources to run clinical trials, which worked very well. When he took up his position at Ahus, they started from scratch.

‘The key to establishing a clinical trial unit is that you must have competent research personnel and research nurses in place. We have that here,’ says Jahnsen.

‘Another criterion for success is being available at all hours,’ says Aure who juggles all the trials and patients and even gives worried patients her private mobile phone number.

‘You also have to be flexible because you may suddenly become aware of a very ill patient who should be included in a trial, which means that you have to do a quick rethink and do everything you can to make it happen,’ says Aure.

Another important factor is that the doctors at Ahus know about the trials, so they often pop in to discuss patients and find out whether any trials are available that are suitable for them. They also hold weekly staff meetings and Aure regularly sends emails about new trials to doctors who treat gastro patients.

Happy with the collaboration

The company AbbVie has a number of products for inflammation of the bowel in clinical development. They started cooperating with Jahnsen and Aure at Ahus back in 2016, according to Kathrine Rasch-Halvorsen. Together with her colleague Cathrine Jacobsen, she works on a number of trials set to start and already running at Ahus.

‘Our impression of Ahus is that Jahnsen and Aure are very motivated, flexible and efficient, while also being good initiators, which produces excellent results. We find that the clinical trials of our products that they are responsible for run very smoothly,’ says Rasch-Halvorsen. She has more than 20 years’ experience of running clinical trials in Norway.

‘For example, Aure will drive to a patient’s home in the evening to give them their medication if necessary, which is just exceptional,’ says Rasch-Halvorsen.

Although standard treatment is effective in many patients with Crohn’s disease and ulcerative colitis, there are still many people who do not benefit from it, and who are then given the opportunity to test the monoclonal antibodies that AbbVie is testing as a drug targeting new points of attack that cause inflammation of the bowel. AbbVie is also set to run gastroenterology trials in Tromsø and Levanger, in addition to several Norwegian hospitals, but they have yet to start recruiting patients.

‘My impression is that the hospitals that succeed in clinical trials in Norway are those where the management set aside resources for the trials and where they appoint clinical research nurses who are 100% dedicated to running the trials. This gives the work an expedient structure, and the doctors who are involved are satisfied, as are the patients and the clients who commission the trials,’ says Rasch-Halvorsen.

The post LEADER IN CLINICAL GASTROENTEROLOGY TRIALS appeared first on Inven2.

Photo: Elisabeth Kirkeng Andersen.

Five children suffering from a very rare disease are being given the opportunity to try a new drug that may help them at Rikshospitalet University Hospital. Sander, aged eight, is one of them, and he looks forward to all his visits to the hospital.

Finding the Pediatric Clinical Trial Unit at Rikshospitalet University Hospital is not easy, but after taking a lift, walking through a corridor, turning right, then left and walking down a passage, I find a nice room with even nicer people.

It is lunchtime and the whole team have set aside time to tell me more about the trial the unit, as the only one in the Nordic countries, is conducting together with a number of other countries across the world, from the USA to Australia.

‘A total of 23 children and young adults aged 3–30 years have this disease in Norway. We call it AT, an acronym for its Latin name Ataxia Telangiectasia, also known as Louis-Bar syndrome. Those affected have lowered life expectancy, and there is currently no treatment to slow the development of the disease. So it’s great that we can at least offer this trial to five children aged 6-9 years,’ says Asbjørg Stray-Pedersen. Stray-Pedersen is a senior consultant, geneticist and works in Newborn Screening at Rikshospitalet.

He is also conducting the trial on the treatment EryDex, developed by EryDel, a small Italian start-up company. The trial is randomised and double blinded, so neither she nor her colleagues know which of the children are given a placebo or the drug. Only Aase Jorun Klaveness who operates the machine that prepares the drug knows that.

The trial started in January 2019 and will run over a prolonged period. Each child receives treatment every third week at the Pediatric Clinical Trial Unit at Rikshospitalet. They spend the whole day at the hospital with their family and the staff at the unit.

Sander’s day

I return to the Pediatric Clinical Trial Unit the following week to meet one of the children, Sander, who is taking part in the trial. Sander, his mum Mariann and nine-month-old little brother Jonas and Mariann’s cousin arrive at the unit at 8.30 in the morning.

They live in Alvdal and came to Oslo a day early so they could go to the Christmas Market at Spikersuppa and for Sander to get a haircut.

‘We try to do something fun in connection with the visits to the hospital so Sander can associate them with something enjoyable,’ says his mum Mariann.

Sander was born in October 2011. His mum suspected something was wrong when he was a baby because he was so bothered by colds. The health clinic refuted this, and said he was an ordinary little boy.

It was not until 2013 that he was diagnosed with AT, and was then found to also be suffering from a type of blood cancer called acute lymphoblastic leukaemia (ALL), a common complication of AT. The family spent a lot of time at Rikshospitalet during this period. Sander recovered from the cancer. His mum Mariann thought that his motor skills improved while he used dexamethasone in connection with his cancer treatment. Dexamethasone is one of the components of EryDex, which is being tested in the trial Sander is now taking part in.

The family had already at that point heard of the trial and that it was coming to Norway, and really hoped that Sander would be one of those selected to take part. And he was. He will spend the entire day at the hospital to be given a new dose of the drug that is being tested.

Sander is a lovely boy. Bright, trusting and cheerful. He is just six months older than my own twins. He loves dinosaurs, his favourite colour is green and he likes maths and Norwegian at school.

‘He is one of the gang at school, goes home with his pals and goes to gymnastics and used to play football,’ his mum says.

Sander is engrossed in his iPad at the hospital, but, even though I’m a stranger, he is still happy to talk to me and to the nurses who will attend to him today.

First he is weighed and then his height is measured, before he has to lie down in a hospital bed where warm bags are placed around the anterior of the elbow to make it easier to insert a venous catheter. The bags of warm water are actually hospital gloves and they can be made into fun figures if you blow them up and draw faces on them, and before long a gang of them are in the bed looking up at Sander.

His mum buys him prawns in the café which Sander eats while he looks at his iPad. He has to come here 12 times in all, at intervals of three weeks.

More common in Norway

There is a lot of AT expertise in Norway, especially at the child habilitation service at Hamar Hospital under Innlandet Hospital Trust. They follow up many of the children and use video recordings to document the development of the disease.

There are particularly many cases of AT in Hedmark County, due to a genetic variant that can be traced back to the Rendalen area. The ‘Rendal mutation’ is one of many different genetic variants in the gene that the disease is linked to.

‘This is a hereditary disease, known as autosomal recessive disorder. This means that both parents are carriers of the condition, but do not have the disease. The parents of children with AT are not usually related to each other, and do not know that they are carriers of the same disease before they have children,’ says Stray-Pedersen.

‘The disease is not immediately evident. The unsteadiness which is very characteristic of AT becomes apparent when the children are around one and a half years old. This means that many families have a second child before their first child is diagnosed. In some families, the second child is also affected,’ explains Stray-Pedersen.

However, there are indications that AT can be identified in children during ordinary newborn screening for immunodeficiency, a common complication of the disease.

‘This poses an ethical dilemma. We can diagnose the disease in babies, but there’s no treatment for it. However, it may be important for families to know about the child’s disease at an early stage. The child and family can then avoid a long investigation process, and the parents will be aware of the risk associated with any subsequent pregnancies,’ says Stray-Pedersen.

‘I dread identifying babies with AT during newborn screening as long as we have no effective treatment to offer these children, but it does provide the motivation for clinical trials. If the treatment is found to work, it will be important to start it at an early stage to slow and stop the progression of the disease,’ says Stray-Pedersen.

Two of the five participants in the trial on the new treatment are siblings. In Norway, there are five cases of siblings having the disease.

‘You must come back’

Sander and I talk about Halloween. He had a skeleton costume and I show him a picture of my children dressed up as a Zombie doctor and Hermione Granger. Then we talk about his dog, a labrador called Kitty, and I tell him about our cat Elly and that it’s her first birthday and that she’s going to have an advent calendar. Kitty is also going to have one.

Sander is still in the hospital bed. Anaesthetist Camilla comes in after a little while. She is going to insert the venous catheter in Sander, and he and his mother watch her eagerly. This can be quite a trial, because it is sometimes hard to find good veins. But Camilla succeeds at the first attempt. Sander’s mum is amazed and wants her to come back in three weeks’ time when Sander is due to be given a new round of the drug.

‘And we must give you something since you did it so well,’ says Sander.

‘It was you that did well,’ replies Merete, the clinical research nurse. Sander lay completely still and didn’t make a noise while Camilla inserted the venous catheter, and simply watched what she was doing.

Then Merete draws 50 ml of blood from Sander. The blood is going to go into a machine which may or may not mix his blood with the drug. As this is a double-blinded, randomised trial, only the person operating the machine knows which of the children will be given the drug. But Sander’s mum Mariann is convinced that Sander is one of them.

‘He has improved since we started the trial. His motor skills are better and he seems more lucid. His assistants at school say that he has more stamina and doesn’t get as tired as he used to,’ she says.

But nobody knows, apart from the woman operating the machine.

It takes around an hour and a half to mix the drug in the machine, and then the blood has to be returned to Sander’s body. In the meantime, he has to talk to a clinical research nurse who has come down from the hospital in Hamar. This is also part of the research protocol, to ensure that Sander is faring well from a mental health perspective during the trial. The rest of us leave the room while Sander talks to her.

His mum tells me that both she and her husband have relations in Rendalen. But they don’t know of anyone else in the family who suffers from the disease. Both Sander’s four-year-old little sister and Jonas are unaffected.

Hope for continued involvement

This trial is going to continue, and the Pediatric Clinical Trial Unit would be delighted to be involved.

The inclusion criteria for this phase were that the children must be aged 6–9 years, and that they had to be capable of some walking without the support of a wheelchair or someone holding their hand.

‘This age group has been selected because the children are old enough to follow instructions and for their motor skills to be tested. They also still have a lot to gain from treatment. During this age range, children with AT usually deteriorate a lot, and many of them lose the ability to walk. This also makes it challenging to measure the effect of treatment,’ says Stray-Pedersen.

Complex treatment for rare disease

‘This trial is a good example of how we in Norway can conduct complicated trials and thus help improve treatment for this patient group who are without other treatment options,’ says Siri Kolle. She is responsible for clinical trials at Inven2, and has been responsible for the research agreements for this trial.

Inven2 has drawn up the agreement for the trial with the Italian start-up EryDel on behalf of Oslo University Hospital (OUS) and Innlandet Hospital Trust.

‘What is also special about this trial is that two hospitals participate in the trial with different roles and logistics but work together as one joint research team. The Pediatric Clinical Trial Unit at Oslo University Hospital, with its expertise in conducting early-phase studies, advanced treatment methods and state-of-the-art research premises ensures that the technical implementation of the treatment is correct and in accordance with the strict guidelines for this drug,’ says Kolle, and goes on:

‘The habilitation service at Innlandet has conducted all the extensive testing of the development of the disease, which is vital to the company being able to assess whether the treatment is effective or not. This is also where the patients attend ordinary check-ups. The constant focus is on children’s experience and participation, and the quality of the data generated,’ says Kolle.

She is deeply impressed by the manner in which the trial is being conducted.

The post New hope for children with rare disease appeared first on Inven2.