Informative Meeting with Hospital Pharmacies about Clinical Trials

Hospital pharmacies across Norway are essential stakeholders in clinical trials. They play a key role both in dispensing investigational drugs to patients and in facilitating some of the documentation required by sponsors. These pharmacies are organized through the National Network for Clinical Trials in Hospital Pharmacies (N-KLUT), led by pharmacist Kari Heimholt.

Addressing Increasing Complexity in Clinical Trials

Recently, LMI and NorTrials hosted a digital meeting for the N-KLUT networkand other interested pharmacists, drawing over 100 people participants. During the session, Ina Dahlsveen from LMI, Signe Øien Fretland from NorTrials, and Frode Bjerkely from MSD presented some of the challenges facing both the industry and Norway in terms of attracting clinical trials. They discussed what it takes to make Norway an attractive country for conducting trials, and how Hospital Pharmacies are vital contributors to this effort.

“We aimed to broaden the perspective and foster a deeper understanding of the industry’s perspectives, which have changed in recent years. Among other things, trials are becoming more complex and the competition is tougher, which means we have to work even harder than before,” says Ina Dahlsveen, Senior Advisor at LMI.

Competition at Every Step
Dahlsveen presented a schematic overview of the decision-making processes in clinical trials, showing that while competition previously occurred mainly at the beginning of the process, there is now competition at every single step.

“Competition doesn’t end just because you've been selected after the feasibility process — it continues through both contract negotiations and study startup. If, for example, you start later with site initiation or patient recruitment than other countries, you may end up being dropped,” explains Dahlsveen.

It is also extremely important to ensure consistency across all study sites.

“Some studies involve up to 45 sites. In such cases, harmonized processes are incredibly important. It's also critical that any unavoidable differences are properly documented. Sites that meet the desired standard are more likely to be selected for future studies,” she says. “Another advantage: if all the other study sites are using one type of equipment, it is best for the Norwegian sites to use the same equipment — if that is what the sponsor prefers”.

Hospital Pharmacies Are Essential
Hospital pharmacies are an essential part of the infrastructure for clinical trials — for patient safety, data quality, and fulfilling certain documentation requirements. They ensure that the most important aspect of drug trials is safely and accurately delivered to patients: the medications themselves.

“That’s why it’s important for us in the industry to have efficient contract processes, so that these do not delay study startup, and that there is predictability when it comes to pricing as well. Although cost isn’t the most critical factor, pricing should not be so high that it drives sites out of the market. Availability and prioritization of resources are also extremely important — even though we fully understand that you are operating under constant resource pressure. That’s why it’s vital to have good communication with both the study site and the PI, so there is a clear understanding of when resources are available and how to prioritize,” she says.

Challenges from the Hospital Pharmacies’ Perspective
Hospital pharmacies highlighted the complexity of their role, often managing around 400 trials with numerous different sponsors, each requiring various types of contracts and equipment — while the industry typically only sees what their own company needs and requests. There was also a call for increased collaboration with CROs and for training those who are less familiar with the Norwegian system, to save both time and frustration.

“It’s important that we are included in the dialogue and that we establish a collaborative relationship, so we can discuss both overarching and more detailed practical matters — such as new directives and how to interpret them,” said Heimholt.

Establishing Collaboration to Minimize Bumps in the Road
She shared that they are now initiating work to develop a national document describing the services provided by the hospital pharmacies. This document will be made available in both Norwegian and English and will be accessible, among other places, on the Inven2 and NorTrials websites.

There are a total of 36 hospital pharmacies in Norway, organized under four hospital pharmacy enterprises. All four enterprises are represented in the National Network for Clinical Trials in Hospital Pharmacies (N-KLUT): Sykehusapotekene HF, Sjukehusapoteka Vest HF, Sykehusapotekene Midt-Norge HF, and Sykehusapotek Nord HF.

As a result of last week’s digital meeting, a collaboration is being established between this network, LMI, and NorTrials.

“LMI sees strong communication with all key stakeholders as an essential to success of   of  conducting clinical trials in Norway. Dahlsveen emphasized. “Ongoing dialogue fosters understanding and builds the trust needed for effective cooperation.”