Updated communication with healthcare personnel and hospitals

LAST UPDATE 27.03.2020 - AHus and Oslo Univeristy Hospital. LMI will continuously publish information we receive from hospitals and HPs regarding clinical trials, collaboration, and other relevant info regarding Covid-19.

Publisert 25. mars 2020

The story is continuously updated. Last update was Monday, 30th of March, 13:30.

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.

This is particularly relevant where patients need to travel to specific hospitals to receive treatments and in multicentre studies that includes participants from several countries. Addtitionally, NorCRIN can report that they will gather information in a more conclusive overview due 26th of March.

St Olav’s Hospital.

The Trondheim-based hospital is at alert level yellow.



All monitoring is stopped, unless specifically required. If monitoring is required, the team will need to find alternative solutions through dialogue with sponsor or monitor.

Initiation of all new clinical trials are, until further notice, postponed, with the exception of COVID-19 studies. Other exceptions might occur, in rare occasions.

Recruitment of all patients to ongoing clinical trials are temporarily postponed.  Any exceptions will be considered individually and based on capacity and alert level. An exception might be considered for clinical trials there study visits coincides with clinical cistis and where the patient is already included in a treatment at the hospital.

Patients included in clinical trials will receive treatment in accordance with protocol provided that is possible. Patient security is of utmost importance. Only mandatory trial related tests or procedures will be conducted, unless other examinations are of medically importance for the patient.

Trial visits should be conducted by phone in guidance with sponsor. Any potential discrepancies will be documented.

As an effort to limit the spread of COVID-19, all monitoring visits are postponed or replaced by remote monitoring.

For employees involved in clinical research, please see St Olav’s main page, “Kilden”, regarding general COVID-19 information- including latest news and patient relations. For non-St Olav employees, please see the St Olav website.

The hospital is still able to support research trials related to COVID-19.

Østfold Hospital

The Østfold hospital is at alert level yellow. They are introducing restrictions regarding monitoring, auditing and inspections of clinical trials, in accordance with the other university hospitals.

Some of the employees in the clinical trials department might be temporarily relocated to another department within the hospital as part of the plan to combat the Covid-19 virus.

Oslo University hospital

The hospital is at alert level yellow.

Initiation of all new clinical trials are, until further notice, postponed, with the exception of COVID-19 studies. Other exceptions might occur, in rare occasions.

Recruitment of all patients to ongoing clinical trials are temporarily postponed.  Following individual consideration from manager, exemptions from the rule of initiating new patients might occur, particularly if the patient is receiving treatment already.

All monitoring is stopped, unless specifically required. If monitoring is required, the team will need to find alternative solutions through dialogue with sponsor or monitor.

Updates information regarding the hospital’s actions against COVID-19 is found at: oslo-universitetssykehus.no/beredskap

The department of cancer treatment at OUS has distributed the following letter in English and Norwegian:

Klinisk-studier-norsk-versjon-1

Klinisk studier english. versjon

 Akershus Univeristy Hospital (Ahus)

Ahus is at alert level yellow.

All monitoring is stopped, unless specifically required. If monitoring is required, the team will need to find alternative solutions through dialogue with sponsor or monitor.

Initiation of all new clinical trials are, until further notice, postponed, with the exception of COVID-19 studies. Other exceptions might occur, in rare occasions.

Recruitment of all patients to ongoing clinical trials are temporarily postponed.  Any exceptions will be considered individually and based on capacity and alert level. An exception might be considered for clinical trials there study visits coincides with clinical cistis and where the patient is already included in a treatment at the hospital.

Patients included in clinical trials will receive treatment in accordance with protocol provided that is possible. Patient security is of utmost importance. Only mandatory trial related tests or procedures will be conducted, unless other examinations are of medically importance for the patient.

Trial visits should be conducted by phone in guidance with sponsor. Any potential discrepancies will be documented.

As an effort to limit the spread of COVID-19, all monitoring visits are postponed or replaced by remote monitoring.

University hospital Northern Norway

The hospital is at a yellow alert level.

All monitoring is stopped, unless specifically required. If monitoring is required, the team will need to find alternative solutions through dialogue with sponsor or monitor.

Initiation of all new clinical trials are, until further notice, postponed, with the exception of COVID-19 studies. Other exceptions might occur, in rare occasions.

Recruitment of all patients to ongoing clinical trials are temporarily postponed.  Any exceptions will be considered individually and based on capacity and alert level. An exception might be considered for clinical trials there study visits coincides with clinical cistis and where the patient is already included in a treatment at the hospital.

Patients included in clinical trials will receive treatment in accordance with protocol provided that is possible. Patient security is of utmost importance. Only mandatory trial related tests or procedures will be conducted, unless other examinations are of medically importance for the patient.

Trial visits should be conducted by phone in guidance with sponsor. Any potential discrepancies will be documented.

As an effort to limit the spread of COVID-19, all monitoring visits are postponed or replaced by remote monitoring.

Haukeland Univeristy Hospital

All new clinical trials at the Haukeland hospital is currently postponed or halted. However, individual considerations and trials in correlation with the Covid-19 virus will be prioritised. Strong criteria for inclusion of new patients in clinical cancer trials will be required.

It is not desired that monitoring, audits or study inspections are conducted in order to limit the spread of the virus within the hospital.

Some patients, such as cancer patients, are involved in clinical treatment trials and will require check-ups. We will conduct study visits at the best of our ability, some discrepancies however will be expected. For patients in quarantine, treatment will be postponed unless significant prognosis loss or critical deteriorating of symptoms occur.

Stavanger university hospital

The hospital is at alert level yellow.

The hospital has temporarily postponed all new clinical trials, unless the trials are directly linked with the COVID-19 pandemic. Recruitment of patients for ongoing clinical trials is temporarily haltered, however individual considerations for inclusion of new patients for cancer trials, can be conducted by manager, if the patient is receiving treatment/follow-ups during the time of the pandemic.

For ongoing clinical trials, where there are planned inspections, the monitor, together with trial management, is required to set up a plan for follow-ups of patient.

Where medically responsible, all follow-ups and consultations should be conducted via phone or video calls. This requires however, that trial participants can answer health questions prior to the conversation. The patient will continue the trial if medically responsible. Where trial medication is continued following consultation, the medicine will be brought to patient via delivery services ( please see information at www.legemiddelverket.no).

Blood samples taken at the clinic, should be delivered through the science post and will be treated as normal. Delivery point and time will be scheduled via the phone, 0047 5151 3325.

All monitoring and visits from external companies are stopped, unless special circumstances are required. Where monitoring is required, the study team will, in dialogue with the sponsor/monitor, find alternative solutions for monitoring (i.e. video or phone).