Off-label Use of Anti-cancer Drugs in Norway -a Prospective Cohort Study

  • STATUS
    Recruiting
  • End date
    Dec 31, 2027
  • participants needed
    200
  • sponsor
    Oslo University Hospital
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Updated on 5 August 2020
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cancer
cancer diagnosis
antineoplastic agents
off label use

Summary

Off-label drug use, where a marketed drug is used outside its approved indication, may allow early access to new and promising treatments. However, its use can be a source of controversy, due to limited evidence for clinical benefit and lack of cost/QALY-estimates, leading to challenging prioritization issues. The number of drugs suitable for off-label use is expected to further increase in the coming years, owing to the rapid progress in the field of oncology, in particular with the current era of precision medicine and targeted therapies. This also challenges the traditional method of running clinical trials, with eligible patient populations commonly being small, underpinning the importance of gaining supplementary real-world evidence from well performed observational studies.

This prospective observational study will therefore assess real-world outcomes of patients treated with off-label anti-cancer drugs, including efficacy in terms of response rates, time to progression/relapse measures and survival; patient-reported outcome measures (PROMS) and self-reported side-effects/toxicity; as well as collecting blood samples for a biobank for further translational research. Further, the study will give a descriptive analysis of the current practice of off-label use of anti-cancer drugs in Norway, including prevalence estimation and health care related cost analyses.

Details
Condition Cancer
Age 18years - 100years
Clinical Study IdentifierNCT04457713
SponsorOslo University Hospital
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Verified cancer diagnosis (based on radiological, histological/cytological or operative evidence)
Treatment with off-label anti-cancer drug
Age 18 years
Able to provide written informed consent

Exclusion Criteria

None
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