At the NorTrials’ 2-year anniversary, a case from feasibility to site selection was presented for a pediatric trial on ulcerative colitis. The potential trial was submitted via the feasibility portal by IQVIA, on behalf of a pharmaceutical company, and the request was forwarded to Oslo University Hospital and Vestfold Hospital Trust, among others. How has it gone?

Sponsor/CRO submits the request via the NorTrials portal

IQVIA is a global CRO firm with 49 employees in Norway. CRO stands for Contract Research Organization, and the firm undertakes clinical research for academia and industry. Marte Frigstad, a Study Start-Up Specialist at IQVIA, has extensive experience using the NorTrials feasibility portal.

- NorTrials has made the feasibility process much easier for us as a CRO. We have used the portal 10-12 times in the past year, in addition to maintaining direct contact with study investigators we know from before. The portal allows us to reach out to more hospitals, including those that have not conducted many studies before. Recruiting more sites to individual trials is something that is seen as a plus by the pharmaceutical headquarters when selecting countries, says Frigstad.

The specific trial Frigstad discusses is the pediatric study on ulcerative colitis.

- For this particular trial, we submitted a feasibility request in the portal in October 2023, she says.

NorTrials forwards the request

Signe Fretland at the NorTrials coordinating unit manages the feasibility portal and manually forwards all inquiries. She received the request for this specific pediatric trial.

- We have already mapped all hospitals in Norway regarding which therapy areas they are interested in studying, so we sent this request to all hospitals that have expressed interest within pediatrics – that means including NorPedMed representing all 6 university hospitals and about 10 local hospitals. NorPedMed is a clinical research network based in the National Competence Network for Drugs in Children. The request was forwarded to the NorPedMed secretary and our contacts at the local hospitals, containing an overview of the study and a deadline for responses, explains Fretland.

She emphasizes that a “yes” at this stage does not bind a potential study site. It is a “yes, we would - like to know more” response.

University Hospital Responds to the Request

Pediatrician and NorPedMed representative at Oslo University Hospital, Per Kristian Knudsen, was among those who responded to the feasibility request from IQVIA. He appreciates the opportunity to contribute to more clinical trials. 

- We would have liked to be part of NorTrials, but over these two years, have established a very good collaboration with the coordinating unit nonetheless. We also want closer cooperation with the other NorTrials centers. NorPedMed and NorTrials should be a unified entity for the industry regarding clinical trials for children, which is crucial for making Norway attractive for future pediatric trials. All university hospitals have experienced pediatricians with allocated time to continue to the Clinical Research Unit. We have a good overview of the nationally network. We want to stand united as a network and provide timely feedback throughout the feasibility request process. For this trial, Oslo University Hospital expressed interest, starting a very good dialog with IQVIA, said Knudsen.

Local Hospital Responds to the Request

Johannes Rolin, Chief Physician at the Pediatric Department at Vestfold Hospital Trust, also received the email about the current trial – via the hospital’s research unit. The Pediatric Department in Tønsberg​ sees approximately 12,000 patients per year, comprising all six therapeutic areas covered by the NorTrials centres.

- In my department, there is a significant commitment to research among the doctors. About one in four has actively engagement in research, however none in a full-time position. Therefore, there is limited capacity to build networks and recruit trials proactively, in this way we are entirely dependent on help and collaboration. I have previously worked alongside Per Kristian, and at that time- five years ago – we experienced significant internal challenges in regards to involved service departments, resources required to start the studies, and most importantly, from the hospital and our local department. There are many moving parts, and today it is much easier to get support and approval for trials. We have more expertise in the department, and without me realizing it, NorTrials had already begun.

So when we were contacted about this particular trial in October 2023, it was nice for me—on behalf of our research group – to be able to say that we have active, qualified clinicians and a good overview of our patient population. Therefore we could respond immediately, and we could say “yes”. It was also beneficial to have support from our new research outpatient clinical, established in January 2024. They have assisted throughout the administrative process required for this trial. Within weeks after the site visit from IQVIA we were grateful to be chosen as a site for the trial, says Rolin.

The hospitals research departments are a valuable resource

Kine A. Wintervoll is the head for the newly established Research Outpatient Clinic that supported Rolin through this process. She credits the Norwegian Cancer Society and NorTrials for the financial support of this clinic.

- We are located in the heart of the hospital, making us easily accessible to both patients, service departments and clinicians. We are here for everyone and aim to support clinicians like Johannes who want to conduct trials but, in a busy daily schedule, have limited time with all the administrative work that is required in addition to consultations. We receive inquiries from NorTrials and coordinate them internally in a timely fashion. We have had a very good start and have currently 14 ongoing trials. I believe the work we do internally contributes to increasing interest in- and, most importantly, motivation for – conducting clinical trials at our hospital, says Wintervoll.

The routines and process works well 

During the winter months of 2024, IQVIA maintained ongoing contact with the sponsor regarding this particularly pedantic trial on ulcerative colitis.

- Moreover, it’s no surprise that Norway, and two sites have been chosen: Oslo University Hospital and Vestfold Hospital. The goal for trial start up is set for December 2024. From the first contact with potential sites in November 2023 – this is a good indication that the NorTrials feasibility portal functions well, says Frigstad.