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Economic burden of clinical trials in lung cancer in a German Comprehensive Cancer Center

F Kron1, A Kostenko1, M Scheffler1

  • 1Department I of Internal Medicine, Center for Integrated Oncology, University Hospital of Cologne, Cologne, Germany; Lung Cancer Group Cologne (LCGC) and Network Genomic Medicine (NGM) Lung Cancer, Germany.

Lung Cancer (Amsterdam, Netherlands)
|June 20, 2017
PubMed
Abstract

Insights

Early lung cancer trials with few patients are not cost-effective. Investigator-initiated trials (IIT) and pharma-sponsored trials (PhST) require careful cost calculation for comprehensive cancer centers (CCCs) to ensure adequate compensation.

Area of Science:

  • Oncology
  • Health Economics
  • Clinical Trial Management

Background:

  • Individualized lung cancer therapy drives changes in clinical research.
  • Focus is shifting to early proof-of-concept trials in small, genetically selected patient subgroups.
  • This study analyzes the economic burden of these trials in advanced lung cancer patients at a German Comprehensive Cancer Center (CCC).

Purpose of the Study:

  • To evaluate the economic burden and profit margins of early proof-of-concept clinical trials for advanced lung cancer.
  • To compare the financial viability of trials based on patient recruitment numbers (≤3 vs. >3 patients).
  • To analyze cost differences between pharma-sponsored trials (PhST) and investigator-initiated trials (IIT).

Main Methods:

  • A profit-center calculation model was used.
  • Clinical and economic data from 27 advanced lung cancer trials (2011-2015) at the Center for Integrated Oncology (CIO) Cologne were analyzed.
  • Profit margins were compared between patient recruitment groups (≤3 and >3 patients).

Main Results:

  • 161 patients were enrolled across 27 trials.
  • Trials with ≤3 patients showed negative profit margins (€ -1444).
  • Significant differences in 'trial visits' were observed between PhST and IIT (p=0.009), with structural cost differences noted.

Conclusions:

  • Trials with low patient numbers and IIT often do not cover costs.
  • CCCs must meticulously calculate costs for early proof-of-concept trials to ensure fair compensation from pharmaceutical companies.
  • Novel public funding structures are needed for investigator-initiated clinical trials in precision medicine.
Keywords:
Cancer centerClinical trialsCost calculationIndividualized therapyLung cancerPrecision medicine

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