Now the Norwegian Health Authority is reacting strongly to the implementation of the study, writes Bergensavisen. – So gross that it is almost unbelievable, says director Jan Fredrik Andresen of the Norwegian Health Authority to the newspaper. Altogether, there were eight university hospitals throughout the country that participated in the “Norwait” study, which was stopped in November 2020. It was Helse Stavanger that coordinated the study. Patients were to be selected according to strict criteria and followed up to investigate whether it was possible to avoid burdensome operations after radiotherapy. The law was broken In Bergen, however, far more patients were admitted than at other hospitals, and a disturbing number had relapses and the spread of cancer, says a report to be published on Thursday. There, the Norwegian Health Authority concludes that both Health Bergen and Health Stavanger have breached the Health Research Act. The same applies to the project manager for “Norwait”, who nevertheless does not lose his authorization or receive other reactions. “We cannot see that the responsible manager has carried out any control of the project and assume that Helse Bergen did not have a system to ensure that the project was carried out properly”, the Norwegian Health Authority writes in the report. Both healthcare institutions are also under investigation by the police because of the cancer study. It was the Norwegian Health Inspectorate that reported the health facilities to the police in January this year. Relapse and spread As many as 20 of 31 patients from Helse Bergen who took part in the study had regrowth of cancer along the way. Eight had spread to other organs, and two of the patients have now died. An external review shows that 16 out of 31 patients should not have taken part in the study. The Norwegian Health Authority’s conclusions in supervision of Helse Bergen and Helse Stavanger Helse Bergen confirmed participation in the multi-centre study Norwait without assessing the need for resources in advance without ensuring that the project had the necessary resources without organizing the operation so that the protocol requirements could be followed without having routines for follow-up of local supervisor/project staff The Norwait study was not carried out at Helse Bergen in accordance with the approved research protocol and REK approval. Helse Bergen allowed the project to continue despite the fact that they were aware that several of the conditions in the research protocol were not followed. The abnormalities have led to several patients with regrowth and metastases. The consequences of the deviations are that more patients are exposed to a higher risk when included in the study at Helse Bergen than was the assumption when the study was pre-approved by REK west. According to the National Health Inspectorate’s assessment, the research has been indefensible. By participating in and carrying out the Norwait study, Helse Bergen has breached the requirement for soundness in medical and healthcare research and the requirement for internal control. There is thus a breach of the Health Research Act §§ 5 and 6 and regulations on the organization of medical and healthcare research §§ 3–5. Helse Stavanger assumed responsibility as coordinating research officer without assessing the need for resources without making sure that other research officers had the necessary resources without ensuring that a follow-up and monitoring plan was drawn up without ensuring that the project manager had the necessary resources without having routines for follow-up of the project manager/project without having routines for contact with the steering group According to the Norwegian Health Authority’s assessment, the organization of the Norwait study has been improper, and the project and project manager have not been properly followed up in accordance with the requirements for internal control. As coordinating research officer, Helse Stavanger has overall responsibility for this. There is thus a breach of the Health Research Act §§ 5 and 6 and regulations on the organization of medical and healthcare research §§ 3–5. The Norwegian Health Authority concludes that the patients at the hospital were not examined as they should have been before the study began, and that there was also no good documentation or follow-up along the way. Helse Stavanger has also “breached the requirements for soundness and internal control in the Health Research Act and related regulations”. – They have broken the conditions for carrying out the study and put people’s lives and health at risk, says Andresen. Sorry – First of all, we would like to once again apologize to patients and relatives who are affected by the case. We take the Norwegian Health Authority’s conclusion very seriously. We are now going through the report thoroughly and will contribute to a constructive dialogue with the Norwegian Health Authority to follow up the inspection case, says specialist director Marta Ebbing at Helse Bergen to Aftenposten.
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Cancer patients participated in a study – spread – news Vestland
