Clinical Trials: Patients Are Willing, But We Haven’t Quite Managed It Yet

“In all these roles, I’ve been involved with clinical trials, but it has not been easy. My experience has been that while the patients are willing, we are not succeeding quite as we should. We are far from reaching our potential,” Skeie notes.

He believes that the increase in study activity, as outlined in the action plan for clinical trials, has primarily occurred in clinics and units that were already engaged in such studies. “It is very challenging to implement this broadly across all hospitals. I’m focused on improvements on the clinic level,” Skeie adds.

This was a key point of discussion during a panel conversation at Arendalsuka, at a meeting organized by NorCRIN, NorPedMed, and NorTrials. During this meeting, several clinicians, hospital leaders, and representatives from industry and patient groups discussed why many Norwegian patients still do not have access to clinical trials.

Many participants highlighted the challenges related to balancing the demands of reducing waiting lists and maintaining high production, with the increasing number of tasks associated with clinical trials. They also emphasized the need for dedicated, professional study personnel and the integration of research into medical education. Time is the scarcest resource in hospitals, and there is also a lack of good role models in some clinics.

Dedicated Personnel Are Crucial

“Dedicated personnel and allocated time are absolutely essential to making this work,” says Camilla Tøndel, Professor of Pediatric Medicine at the University of Bergen and Head of the Clinical Research Post for Children and Adolescents at Helse Bergen.

“I have been involved in drug trials for over 15 years and have participated in around 50 studies, so this is something I am truly passionate about. What is disheartening is that clinical departments receive funding for ‘production’, meaning patient care, while research is seen as ‘playing’. This is completely wrong because it’s research that drives patient care forward and contributes to better treatment,” Tøndel points out.

She emphasizes the meaningfulness of research. “The value of research is something we must not forget. Additionally, being a study nurse or study coordinator is a profession in itself. Having dedicated personnel who understand clinical trials makes the process much more efficient. We need a system and structure that can be utilized by departments where few studies are conducted. Therefore, a general research post at the hospital is extremely important,” says Tøndel, referring to a famous quote from the children’s TV series Karsten and Petra: “Practice makes perfect, just look at Ester.”

Tøndel’s views are echoed by her colleagues, including Terje Rootwelt, Leader of Helse Sør-Øst and Chairman of NorTrials.

“Conducting industry-funded clinical trials is complicated, and it’s difficult for everyone to master all the details. This is why they need to be handled by professionals. Here, clinical research posts and study nurses are crucial—you need a staff of permanent employees who are experienced in the field of clinical research. One of our four legally mandated tasks is research—a challenging task. We must ensure that it can be carried out as effectively as possible. A major challenge is the capacity within hospitals to conduct studies, including among doctors and support functions such as laboratories and radiology. Additionally, the complex regulations that must be adhered to make it essential to be professional in execution so that this task doesn’t become insurmountable,” said Rootwelt.

Henrietta Blankson, Senior Advisor at the Research Council of Norway, points out that OsloMet has a master’s program that trains study nurses, and Kristin Bjordal, Head of Regional Research Support at Helse Sør-Øst, reminds us that NorCrin offers courses for study nurses and study personnel.

“But it’s important that those in leadership roles within hospitals and clinics facilitate for employees to attend the necessary courses,” says Bjordal.

Leadership and Board Support Are Essential

Terje Rootwelt emphasized the importance of leveraging the networks within NorTrials, NorCRIN, and NorPedMed to ensure that the process is no more difficult than necessary. He also underscored the importance of receiving support from hospital leadership and the board.

“At Helse Sør-Øst, we receive approximately 350 million NOK from the ministry allocated for research, and Helse Sør-Øst adds roughly the same amount. It takes significant effort to get the board to agree when finances are tight, but it is important that they are involved and that it is communicated throughout the leadership chain that this is a prioritized task—on par with other activities. It’s a tough prioritization, but crucial if patients are going to receive the best possible treatment,” says Rootwelt.

A Pressing Challenge That Must Be Addressed

One of the issues, according to Svein Skeie, is that no tasks are removed from the existing list for clinicians and nurses—but new ones are added.

“There is a cross-pressure in the clinic that is difficult to resolve, and there is something structural in the hospitals that hasn’t been properly addressed. Some are able to manage it, but to create a system that works across all hospitals—beyond enthusiasm—I think we need to do more within the clinics’ systems, below the hospital leadership level,” says the Research Director.

Resident Doctors Must Be Included

Skeie believes there is great potential for increasing the focus on clinical research early on in doctors’ careers.

“During medical training, there is a requirement for medical students to learn a certain amount about research. However, once one is a fully qualified doctor, the real workload begins. Then it is entirely up to the individual doctors whether they want to be involved in research—in addition to their clinical duties. Research and studies should instead be a part of the curriculum throughout resident training, exposing doctors to the research culture as an integrated part of the clinic. Improving clinical trials is not just about increasing the number of clinical trials; it is about the bigger picture—improving patient care and treatment. Unfortunately, many resident doctors do not have a role model to look up to who is involved in clinical trials. At the same time, doctors are on call, busy trying to reduce waiting lists, manage tight budgets, and deal with limited radiological capacity, and so on,” says Skeie.

The Action Plan Must Be Operationalized

Geir Bråthen, Clinic Head at the Neurology Clinic at St. Olavs Hospital, says he feels caught between a rock and a hard place concerning the government’s demands regarding increasing productivity in both daily operations and within research.

“But what I’ve heard here today is something I’ll take home and work more actively on than I have until now: how we can actually make resources visible at the department level and use research funds to strengthen research. There are many good points in the Action Plan for Clinical trials. The goal going forward must be to successfully operationalize what’s stated in the document,” says Bråthen.