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Investigator-initiated trials of targeted oncology agents: why independent research is at risk?

L Bergmann1, B Berns2, A G Dalgleish3

  • 1Cancer Center Rhein-Main, Medical Clinic II, J.W. Goethe University, Frankfurt, Germany.

Annals of Oncology : Official Journal of the European Society for Medical Oncology
|February 6, 2010
PubMed
Abstract

Insights

Academic research is crucial for discovering new cancer therapies but faces decline due to rising costs and regulations. A new model is proposed to foster collaboration between academia and industry for sustained innovation in drug development.

Area of Science:

  • Drug Development
  • Cancer Therapy
  • Biotechnology

Background:

  • Traditional drug development relies on academic and industry collaboration.
  • Increased regulatory burdens and costs pressure the drug development pipeline.
  • Exploratory academic research, vital for new drug targets and therapies, is de-emphasized.

Purpose of the Study:

  • Examine the growing schism between academic and industry research.
  • Identify causes for the decline in academic research.
  • Propose solutions to sustain investigator-initiated research.

Main Methods:

  • An expert panel from the Biotherapy Development Association was convened.
  • The panel included academic researchers, industry professionals, patients, and regulatory agencies.
  • The panel analyzed the challenges facing academic research in drug development.

Main Results:

  • Several causes for declining academic research were identified.
  • A new model is proposed to foster collaboration between academia and industry.
  • This model facilitates planning studies within a regulatory framework for new molecularly targeted agents and biomarkers.

Conclusions:

  • Investigator-initiated trials are essential for discovering innovative cancer treatments.
  • Sustaining academic research requires action from legislative bodies, regulatory agencies, industry, universities, and patient advocates.
  • Collaboration is key to ensuring the continued development of safe and effective cancer therapies.

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