These are the Nominees in the Category Investigator-Initiated Trial of the Year

The nomination process began in autumn 2025, and the jury received more than 100 nominations across the six categories: Centre of the Year, Researcher-Initiated Trial of the Year, Industry-Initiated Trial of the Year, Innovative Environment of the Year, Young Researcher of the Year, and Enthusiast of the Year.

Following a thorough evaluation process, the jury has shortlisted a small number of nominees in each of the six categories.

The nominees for Investigator-Initiated Trial of the Year are:

• The BETAMI trial

• The CandMig trial

• The IMPRESS trial

• The OVERLORD-MS trial

• The REST trial

The BETAMI Trial

The BETAMI trial is a groundbreaking study that exemplifies excellence in clinical research and collaboration, bringing together Norwegian and Danish expertise in cardiovascular medicine. The trial, led by Dan Atar (Oslo University Hospital HF) and John Munkhaugen (Vestre Viken Hospital Trust), together with the similar DANBLOCK trial, included more than 5,500 patients across 44 hospitals in Norway and Denmark.

The aim was to determine whether beta-blockers should still be routinely prescribed to patients with a recent myocardial infarction and preserved or mildly reduced cardiac function. International guidelines worldwide strongly recommend this medication; however, the evidence underpinning these recommendations is more than 40 years old, and the management of myocardial infarction has since undergone major changes, including acute revascularisation. The cardiovascular community therefore questioned whether this treatment might be outdated.

In 2025, the trial results were presented at the European Society of Cardiology (ESC) Congress in Madrid and simultaneously published in The New England Journal of Medicine. The results demonstrated a significant reduction in the risk of recurrent myocardial infarction and cardiovascular events in patients with a left ventricular ejection fraction (LVEF) >40%. In addition, two important meta-analyses of subgroups with mildly reduced cardiac function (LVEF 40–49%) and preserved cardiac function (LVEF >50%) were published in The Lancet and The New England Journal of Medicine, respectively, with BETAMI playing a central role.

These findings conclusively establish that patients with a certain degree of myocardial injury following a myocardial infarction should continue to receive beta-blockers, whereas patients with normal cardiac function do not require this treatment. The results will undoubtedly influence clinical guidelines globally, underscoring the importance of re-evaluating established practice through rigorous research.

The CandMig Trial

The CandMig trial is a pharmaceutical trial for episodic migraine conducted under the auspices of the Norwegian Centre for Headache Research (NorHead), led by St Olav’s Hospital and NTNU. The CandMig trial is part of a larger KlinBeForsk project (OptMig – Optimising Migraine Prevention), which aims to increase the use of preventive medications in migraine patients with frequent attacks in order to reduce the substantial disease burden associated with this condition.

An important premise for the trial was that migraine, according to the Global Burden of Disease project, is one of the conditions that causes the greatest loss of health at population level in terms of Years Lived with Disability.

In the CandMig trial, the antihypertensive drug candesartan was investigated in a three-arm, parallel, randomised controlled trial (RCT) using two different doses and compared with placebo. A total of 457 patients with episodic migraine were included at nine hospitals across Norway, as well as one hospital in Estonia.

Trial participants used a digital data-collection tool with a headache diary, enabling decentralised trial conduct. The tool was developed in collaboration with the spin-off company Nordic Brain Tech AS. At national level, the trial has already resulted in patients being able to receive reimbursement from HELFO on an individual basis, and efforts are ongoing to include the medication in the standard reimbursement scheme.

Internationally, the findings indicate that candesartan will be recommended as a first-line option for the prevention of episodic migraine in forthcoming international guidelines.

The results were published in The Lancet Neurology, the world’s leading neurology journal, in October 2025, and were also presented at both the European and the International Headache Congresses.

Funded by the Research Council of Norway (RCN), the trial has been central to the establishment of national infrastructure for conducting new researcher-initiated headache trials in Norway. A national recruitment database has also been established for patients with headache disorders who have consented to be contacted for future trials. The database now includes more than 5,000 registered individuals.

The IMPRESS Trial

IMPRESS is a nationwide trial in which cancer patients with advanced disease, who no longer benefit from standard treatment, are offered extended molecular diagnostics. Patients whose tumours harbour molecular alterations suggesting that targeted therapy may be effective can be offered such treatment through IMPRESS-Norway, provided that the relevant drug is included in the trial’s drug portfolio.

IMPRESS-Norway collaborates with the pharmaceutical industry to ensure access to medications and has entered into, or previously held, agreements covering a total of 25 different drugs from nine different companies.

Since the launch of IMPRESS-Norway in April 2021, nearly 4,000 patients have been included in the screening phase of the trial, and more than 500 patients have been offered treatment within defined treatment cohorts, of whom more than 400 have initiated treatment. Among those who started treatment, approximately 45% experienced clinical benefit, despite having already undergone multiple prior lines of therapy.

The IMPRESS trial would not have been possible without the establishment of the Infrastructure for Precision Diagnostics in Cancer (InPreD). The establishment of InPreD and IMPRESS-Norway has accelerated the implementation of precision medicine in cancer care in Norway and has contributed to a comprehensive national upskilling in precision medicine, benefiting patients across the country.

The OVERLORD-MS Trial

OVERLORD-MS (Ocrelizumab Versus Rituximab Off-Label at the Onset of Relapsing MS Disease) is a randomised, double-blind, non-inferiority trial comparing rituximab and ocrelizumab as first-line treatment in patients with newly diagnosed relapsing-remitting multiple sclerosis (RRMS).

Funded by KLINBEFORSK and led from Haukeland University Hospital with Professor Øivind Torkildsen as coordinating principal investigator, the trial included 216 patients from 12 hospitals in Norway and Sweden. Results became available in 2025.

OVERLORD-MS demonstrated equivalent efficacy and safety between the two treatments and has had a direct and substantial impact on clinical practice. The trial contributed to the inclusion of rituximab in the national clinical guidelines for multiple sclerosis issued by the Norwegian Directorate of Health. Today, approximately 5,000 patients in Norway receive rituximab for the treatment of MS.

Implementation of the trial’s findings has resulted in annual cost savings of approximately NOK 500 million for Norwegian hospitals, without compromising treatment quality. OVERLORD-MS represents a rare example of how publicly funded, researcher-initiated clinical research can lead to rapid changes in practice, high patient benefit and significant socioeconomic gains.

The REST Trial

The REST trial is an academic, single-arm, open-label phase II trial investigating a novel combination treatment for elderly patients with newly diagnosed multiple myeloma who are not candidates for autologous stem cell transplantation.

The trial is led by Frida Bugge Askeland as part of her doctoral work and has been conducted at the Oslo Myeloma Centre at Oslo University Hospital HF, the University of Oslo, Stavanger University Hospital, St Olav’s Hospital HF, Aarhus University Hospital, Odense University Hospital and Copenhagen University Hospital (Rigshospitalet). The trial was conducted in collaboration with the Nordic Myeloma Study Group (NMSG).

The REST trial was published in The Lancet Haematology in February 2025 and has received significant international attention. In summer 2025, the results were incorporated into updated European guidelines for the treatment of multiple myeloma and have also led to direct changes in Norwegian treatment recommendations for elderly myeloma patients.

A user group at the Oslo Myeloma Centre (OMC) provided advice throughout the project.

The REST trial represents an important step towards more personalised and better tolerated treatment for elderly patients with multiple myeloma.

The text was translated from Norwegian using ChatGPT and reviewed by Ellen Johnsen.