Bias after censoring concomitant users of test- and control medication when investigating long-term survival outcomes in observational studies of medication effects

Study identification

• EU PAS number:
  EUPAS1000001159
• Study ID:
  1000001159
• Official title and acronym:
  Bias after censoring concomitant users of test- and control medication when investigating long-term survival outcomes in observational studies of medication effects
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Simulation study to estimate bias and compare methods to handle situations in active comparator studies investigating long-term survival outcomes, such as time-to-cancer-diagnosis, where the drug of interest and the active comparator drug are used concomitantly.
• Study status:
  Planned

Research institutions and networks

Institutions

Pharmacoepidemiology Research, Federal Institute for Drugs and Medical Devices (BfArM)

Germany

Networks

Real4Reg

Belgium

Denmark

Finland

Germany

Ireland

Portugal

Study timelines

Date when funding contract was signed

Planned:01/01/2023

Study start date

Planned:16/11/2026

Date of final study report

Planned:31/12/2026

Sources of funding

EU institutional research programme

More details on funding

HORIZON Europe

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable