- Sofia Lindén
Kicking off the Clinical Trials meeting series
CONNECT gathered Norwegian stakeholders in oncology to discuss industry-sponsored clinical studies.
Industry-sponsored clinical studies in Norway were in focus at the kick-off meeting for a new meeting series hosted by CONNECT Working Group 2 on 20 September 2022.
The National Action Plan for Clinical Studies in Norway by the Ministry of Health and Care Services has set out several ambitious goals. They wish to double the number of clinical studies by 2025 and that 5 per cent of all patients in the Specialist Health Service should be treated in a clinical trial.
Cathrine Notland, Medical Lead Oncology at Pfizer Norway, opened the kick-off meeting by introducing the topics for discussion.
“To achieve the goals set out in the action plan, we need good collaboration and understanding about the different actors involved in clinical studies. How are countries and sites chosen? Which parameters are evaluated? How can hospitals attract and succeed with such studies?”
Watch the meeting here (only in Norwegian):
How pharma companies pick clinical sites
The first speaker to tackle these complex issues was Nicolas Vaugelaude-Baust, Medical Head at Novartis Norway. He explained how Novartis monitors progressions and deliverables in clinical studies.
“The number of commercial clinical studies in Norway has been in steep decline. This is a great shame and affects both the patients and the development of skills in the clinic. Europe has lost ground in comparison to USA and emerging markets when it comes to attracting clinical trials,” Vaugelaude-Baust commented.
Vaugelaude-Baust said that the pharmaceutical industry invests approximately USD 179 billion in research and development globally every year. It has also become more expensive to run development programs. This means pharma companies are more selective when choosing clinical sites and they gather historical data to see which countries deliver well.
“Norway delivers great quality, but it is not enough to be best in the Nordics or Europe. You need to be best in the world. In addition to delivering great quality, you need to be fast. Norway has some advantages, with strong health registries and unique ID numbers that can connect these registries. The Norwegian population is also highly technological, which is a great advantage when running decentralized studies.”
What pharma companies can do locally
Then Cathrine Notland presented how Pfizer work locally to attract clinical studies in oncology to the region. The status for oncology studies in Norway was dismal during 2017-2019 with few active studies and few new feasibility requests for participation in new studies. Pfizer therefore set up a Nordic Task Force to turn the negative trend around.
“First of all, it is difficult to get requests if you are not in the top prioritized countries. The next obstacle is to respond to the request quickly and be selected for participation. When you have been accepted, you also need to recruit the number of patients requested to be an attractive country in the next round,” Notland explained that this is a loop you need to get into, and work hard to stay within.
The Task Force was created as a collaboration between the local Medical Oncology Team and the clinical departments at Pfizer. They prepared for new studies and therapeutic areas, and they also “promoted” Norway as a suitable country for selected clinical studies internally. They systematically mapped out the challenges and worked strategically to change them.
“We saw for instance that Norway had very long start-up timelines in our internal system, which we did not recognize and with documentation of timelines for recent studies, were able to reduce this. This made Norway an eligible country to be selected for studies. We also saw there historically had been much focus on attracting phase 1 and 2 trials, but that we had a greater chance of success with phase 3 trials,” Notland commented.
The number of feasibilities for oncology clinical trials in Norway has increased the last two years.
“The number will always fluctuate over the years with various study-programs being initiated or ending, so we cannot say that the increase is only due to our internal work. And one thing is the number of feasibility requests, but the most important part is to be selected to participate in studies. We are completely dependent on Norwegian hospitals to collaborate with us on this and we are so happy that we this year are starting several new studies in Norway,” Notland emphasized.
How hospitals can attract clinical trials
The final speaker was Odd Terje Brustugun, senior oncologist at Drammen Hospital. The hospital has a relatively small cancer clinic but has been successful in getting industry-sponsored clinical trials.
“It is possible to attract clinical trials, even at a smaller hospital, but there are some critical factors, which I call the seven P’s: Patients, Personnel, Projects, Penger (Money), Partnerships, Prestige and Passion,” Brustugun said.
Brustugun explained that to find eligible patients for clinical studies, the hospital needs to market and inform about on-going clinical studies, which Drammen Hospital has done through the website and a mobile app.
Another bottleneck, according to Brustugun, is having enough health personnel available to deliver the clinical trial. At Drammen Hospital, they have invested in two doctors that work actively with and feel ownership to clinical trials.
A point Brustugun stressed is picking the right projects and that a small hospital has the best chance of running phase 2 and phase 3 trials.
“The most critical factor is money. Time is money, so you need to get started quickly. Facilities also cost money. This is something the hospital management needs to take seriously, because there is an economical gain in running clinical trials, since you get treatments for free,” Brustugun said.
Brustugun then talked about the importance of being a good partner, both externally with the industry and internally between hospital departments, as well as across borders with other Nordic countries.
“This is something the hospitals should view as a non-material gain, because you will be seen as a hospital at the research front and gain a good standing in the milieu,” Brustugun commented on the prestige aspect.
Finally, Brustugun emphasized that there needs to be a passion from the hospital staff to
perform clinical trials. It needs to be in the heart of the health personnel in the hospitals.
Did you find this topic interesting? The next meeting in the series will highlight Academic / investigator-initiated studies – How to succeed in the hospitals: what is needed? How does the industry view support of independent research? How can you navigate strategies and different industry processes? Please register via Zoom here: https://us02web.zoom.us/meeting/register/tZ0pduqsrjksHNc6S63nvugf2983HILOZd3L