The story is continuously updated. Last update was Tuesday, 9th of June, 1130.
On Friday, LMI sent a letter to the Directorate of Health and the Norwegian Institute of Public Health regarding Corona contamination and contact between employees from the pharmaceutical industry and hospital/ healthcare staff. We are also in contact with various hospitals following the news that the Corona virus is affecting clinical trials.
The Norwegian Medicine Agency are informing on their website that changes conducted in clinical trials as a consequence of Covid-19 are considered security/safety measures and can be implemented prior to their approval. The agency has also initiated a fast track lane for clinical trial applications with the indication to prevent or treat Covid-19. Additionally, they have also added a FAQ-site related to Covid-19 and clinical trials.
It is initiated restrictions at most hospitals, and they are also in “yellow” emergency preparedness alert, LMI have been told. Meaning that scheduled treatments or procedures might be postponed and that all personnel might be redisposed.
NorCRIN
NorCRIN, which is the national research infrastructure for the six university hospitals, can inform us that – as per 13th of March – it is too early to conclude what consequences the new restrictions will impact clinical trials. However, it will certainly affect patients and likely limit monitoring and direct meetings, as well as limit the recruitment of new patients, they informed.
St Olav’s Hospital.
The Trondheim-based hospital is at alert level green.
Both clinical trials and other elective activities are now open. For each department, its manager will decide whether it is desirable to start new projects due to risk assessments.
For each trial, it will be made individual decisions, assessing the scope of the project. Whether it includes physical presence and assessments or consultations that would not be conducted otherwise or whether additional equipment is required, are taken into consideration.
If any additional consultations are required, these will be assessed as ordinary consultations. The applications will subsequently be assessed bt a specific management committee, across all departments, clinics and areas of expertise. The contact person is Gunnar Morken.
Østfold Hospital
The hospital is on alert level green. The hospital will try to adapt and ensure that completion and initiation of clinical trials given capacity and that they can occur within the responsible framework and spread constrains.
The same rules apply to patients who are being followed-up in clinical trials as to patients receiving ordinary treatment. Patients must have a summon they can display at the entrance. It is, temporarily, permitted that monitors residing in Norway, may follow up physically to monitor or at initiation meetings. After June 15th, monitors from Denmark will be allowed to enter. During monitoring visits, the following guidelines are to be followed:
Ordinary spread constraints (distance, hand hygiene etc) must be followed when meeting trials personnel. The monitor must, to the extent it is possible, chose the travel route to hospitals that does not expose the monitor fear of spread. Privat transport should therefore be preferred.
Written confirmation from trail personnel
If the tester already is known to the personnel, the request might be sent directly to the trial personnel. If not, any questions regarding feasibility, please contact kliniskestudier@so-hf.no.
Oslo University hospital
Oslo University Hospital is at alert level green
A green alert level indicates that the hospital is restarting some its elective activity. As far as research is concerned, the hospital will strive to ensure the completion of clinical trials, provided there is capacity to conclude these within responsible framework and efforts to contain spread.
For clinical trials, the following criteria will apply:
- Priorities are based upon individual decisions for each trial, to which one of the conditions are whether the trial is therapeutically useful for the patient.
- Expected consequence/injury/inconvenience by postponing will be considered
- How the trial will affect other activity in the specific clinic, which includes supporting clinics
- To which extent the trial contributes to risk of spreading the virus, in relation to protecting both patients and personnel
For ongoing industry-financed studies, the clinic leader must contact Inven2 if there are any risk of significant postponement. Close dialogue between the parties is recommended- also considering potential covid19-related issues related to patient follow-ups.
For new trial agreements, where negotiations are concluded, a new assessment needs to be done to review if the deal can be signed in light of the abovementioned criteria.
Oslo University Hospital are eager to highlight that clinical trials are an integrated part of the hospital’s core responsibilities. Ensuring the follow-through of the abovementioned criteria are therefore, first and foremost, important to guarantee responsible operations in an uncertain and changing time.
To ensure smooth and rapid follow-up regarding feasibility and other trial related questions, we kindly request that they are directed to ; kliniske.oppdragsstudier@ous-hf.no. It is also possible to contact research support directly: ved Ellen Johnsen (mob. 48230256) eller Peder Utne (mob. 91619215).
Akershus Univeristy Hospital (Ahus)
The hospital has restarted some its operations.
the following recommendations has been given:
- The start of new clinical trials are continuously assessed and prioritised by the administration in each clinic/department.
- The initiation of recruitment of patients to ongoing clinical trials are assessed and prioritised by the administration for each clinic/department.
- Due to prioritisation, treatments that are curative might be prioritised.
- If there is an expected negative consequence following postponement, it needs to me reported to the project leader og sponsor.
- Required lack of COVID-19 spread, as recommended by the FHI and health authorities are to be followed.
University hospital Northern Norway
The hospital is at a Green alert level.
- Initiation of new clinical trials are limited, except COVID-19 trials
- As of april 20th, elective activities are open at UNN, albeit under strict rules to prevent spread. This includes activities in clinical trials.
- Recruiting new patients to ongoing clinical trials is under consideration and based on capacity at respective facilities.
- Monitoring while at yellow alert level, will primarily consist of off-site monitoring. Pending agreement between study team and sponsor/monitor.
- All UNN employees,are referred to the site containing all COVID-19 related issues.
Haukeland Univeristy Hospital
It is opened up to assess new clinical trials. It may however still be that some of the departments are less active than in a normal situation. Trials deemed important for patients who otherwise would not receive sufficient care and trials where vital treatment is given, will be prioritised.
Ongoing clinical trials will gradually resume to normal. Studie inspections, with a physical presence, might be conducted after careful pre-screening in accordance with the hospital rules. For patients in quarantine, treatment will be postponed unless significant loss of prognosis or critical deterioration of the illness occurs.
Physical monitoring of trials might be conducted if deemed essential. Absent monitoring is recommended.
Stavanger university hospital
The hospital is at alert level green.
The hospital is now open to assessing new clinical trials. It may still be some departments with reduced activity, compared to normal.
Trials deemed important for patients who otherwise would not receive sufficient care and trials where vital treatment is given, will be prioritised.Ongoing clinical trials will gradually resume to normal. Studie inspections, with a physical presence, might be conducted after careful pre-screening in accordance with the hospital rules. For patients in quarantine, treatment will be postponed unless significant loss of prognosis or critical deterioration of the illness occurs.
Physical monitoring of trials might be conducted if deemed essential. Absent monitoring is recommended.