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.