Patients can be referred to relevant trial therapy abroad, typically for highly specialized trials and/or very rare and serious conditions, e.g. cancer. The requirements for patient-facing material etc. are those of the country where the trial takes place.
However, patient facing materials in native languages templates applicable under CTR should be considered.
Information from the Danish Health Authority (Sundhedsstyrelsen):
ævnfør Bekendtgørelse om ret til sygehusbehandling m.v. kapitel 5 ret til behandling i udlandet m.v. §29 kan et regionsråd tilbyde en patient henvisning til forskningsmæssig behandling i udlandet:
· Hvis patienten er blevet undersøgt eller behandlet på en sygehusafdeling i Danmark, der har lands- eller landsdelsfunktion for den konkrete sygdom
· Hvis denne sygehusafdeling har indstillet patienten til forskningsmæssig behandling på en bestemt sygehusafdeling i udlandet
· Hvis behandlingen i udlandet, opfylder kravene til anerkendte videnskabelige forsøg og foregår i samarbejde med det danske sygehus.
· Den henvisende afdeling skal indberette forskningsmæssig behandling til Sundhedsstyrelsen
Den forskningsmæssige behandling skal opfylde almindeligt anerkendte krav til videnskabelige forsøg og foregå i samarbejde med et dansk sygehus.
Såfremt det drejer sig om henvisning til forskningsmæssig eller eksperimentel behandling i udlandet henvises til patientens bopælsregion.
Deepl Translation:
According to the Executive Order on the right to hospital treatment etc. chapter 5 right to treatment abroad etc. §29, a regional council can offer a patient referral for research-related treatment abroad:
· If the patient has been examined or treated at a hospital department in Denmark that has a national or regional function for the specific disease
· If this hospital department has referred the patient for research treatment at a specific hospital department abroad
· If the treatment abroad fulfils the requirements for recognised scientific trials and takes place in collaboration with the Danish hospital.
· The referring department must report the research treatment to the Danish Health Authority
The research treatment must fulfil generally recognised requirements for scientific trials and take place in collaboration with a Danish hospital.
In the case of referral for research or experimental treatment abroad, referral is made to the patient's region of residence.
Damages are managed by the Patient Compensation public entity, covering public hospitals and ensuring fair resolution for patients wherever they live.
Patient Compensation public entity, which is dealing with any damages, where all public hospitals are affiliated to this entity.
The patient's current treating physician can apply to the patient’s health care region in Denmark to cover the costs for trial therapy abroad if it is the best available treatment option.
The documentation of such a payment guarantee is typically given by issuing an S2 form to the patient.
There is nothing specific requiring any additional insurance for a participant already covered by public health insurance.
There is no national legislation or guidance available that specifically covers legal aspects of the inclusion of subjects from other countries.
However, there is Bekendtgørelse om anmeldelsespligtige sundhedsvidenskabelige og sundhedsdatavidenskabelige forskningsprojekter / Executive Order on notifiable health science and health data research projects.
Chapter 3 §10 Subsection 2 says "Information for the study subject must contain an understandable presentation of the research project without the use of technical or value-laden
For a patient living in another country in EU wanting to participate in a clinical trial in Denmark the investigator needs to enable the availability of patient facing materials in a language the patient can read and understand (but not necessarily the mother tongue) CTR requirements to be considered when it comes to subject materials (any mandatory templates).
In the CTR platform (CTIS), documents translated to other languages are NOT required and NOT accepted. It's the responsibility of the trial sponsor and the local investigator that the material used are a correct translation of the patient-facing material used in the country where the trial takes place.
Patient information must be translated into a language the subject understands, and interpreters must be present if necessary.
In practice this requirement also cover that the Patient Information and Consent Form is provided in a language that the subject understands and the conversation about participating is conducted in a language the subject understands. If the site staff does not have the necessary language competencies, an interpreter must be present at all site visits.
Under the former Clinical Trial Directive the inclusion of participants from other countries were notified to the Ethics committees in local submission documents. All patient facing materials were after full regulatory approval translated from Danish into the appropriate languages, to ensure that the information given in other languages is identical to the materials approved by the authorities. Under CTR, such documents are still to be correctly translated, but are NOT to be uploaded to the CTIS platform, or sent to the authorities.
Damages are managed by the Patient Compensation public entity, covering public hospitals and ensuring fair resolution for patients.
Patient Compensation public entity, which is dealing with any damages, where all public hospitals are affiliated to this entity.
Commercial (industry) sponsors have to cover all the trial related costs. Baseline costs not covered by the trial must be covered by the patient’s home country health care system or health insurance.
For non-commercial sponsors (investigator-initiated trials), the patient’s home country health care system or the patient’s health insurance must cover the trial costs not paid by the trial sponsor and the local investigator.