IQWiG in dialogue 2014
Benefit assessment in studies with allowed treatment switching
Switching treatments during a clinical study, e.g. from the control to the treatment arm with the new drug, does not only have consequences for the patient, but also for the assessment of study data by the regulatory authorities and IQWiG: Particular requirements and methodological problems for the informative value of the data result from this treatment switching.
But would it be ethically justified at all to withhold a drug from a patient by prohibiting treatment switching in clinical studies if, in the course of the study, this drug turns out to be probably effective, and to treat this patient with best supportive care instead? In many cases, particularly in oncology, investigators tend to generally allow patients to cross over from the control to the treatment arm already during the study – despite the problems this causes for the analysis of the study results.
The presentations and discussions at this year’s “IQWiG in dialogue” therefore deal with the particular requirements and methodological problems from the perspectives of clinical practice, regulatory approval, research and IQWIG.
- The ethical dimensions of studies with allowed treatment switching Professor Dr Daniel Strech, Hanover Medical School (MHH)
- Criteria for treatment switching in oncological studies Professor Dr Bernhard Wörmann, German Society of Haematology and Oncology (DGHO)
- The role of the Federal Institute for Drugs and Medical Devices (BfArM) in the planning, authorization and acceptance of clinical studies and their results in oncology PD Dr Thomas Sudhop, BfArM
- Evaluation of treatment switching in the Institute’s assessments Dr Volker Vervölgyi, IQWiG
- Methods to estimate survival time after treatment switching in oncology – overview and practical considerations Dr Norbert Hollaender, Novartis
- Adjustment of overall survival (OS) after crossover – aspects from the perspective of the benefit assessment Professor Dr Ulrich Mansmann, Ludwig Maximilians University (LMU) Munich