Investigator-initiated trials of targeted oncology agents: why independent research is at risk?
BACKGROUND
Drug development traditionally has relied upon the complementary contributions of clinicians and scientists at academic institutions and at pharmaceutical companies. Greater regulatory burdens, increased bureaucratic requirements, restricted reimbursement, and spiralling research and development costs are exerting pressure on the drug development pipeline. The result is a de-emphasis of exploratory research, particularly independent academic research, despite its proven value in identifying new drug targets and developing innovative cancer therapies.


METHODS
An expert panel assembled by the Biotherapy Development Association-a nonprofit international forum for academic and industry researchers, patients, and government regulatory and postregulatory agencies-examined the growing schism between academia and industry and identified several causes of declining academic research.


RESULTS
The authors propose solutions to sustain investigator-initiated research and provide a new model whereby expert organisations provide a forum for academia and industry to plan studies within a regulatory framework to support licensure/authorisation and reimbursement for new molecularly targeted agents and biomarkers.


CONCLUSIONS
Investigator-initiated trials have led to the discovery and development of innovative, safe, and effective cancer treatments. To ensure that such research continues, action will be required on the parts of legislative and regulatory bodies, industry, universities, patient advocacy organisations, and preclinical and clinical academic scientists.
Bergmann
L
L
Cancer Center Rhein-Main, Medical Clinic II, J.W. Goethe University, Frankfurt, Germany.
Berns
B
B
Research and Development, Ortho Biotech Oncology, High Wycombe.
Dalgleish
A G
AG
Division of Oncology, St George's Hospital Medical School, University of London, London.
von Euler
M
M
Oncology Clinical Development, Roche, Welwyn Garden City, UK.
Hecht
T T
TT
National Cancer Institute, National Institutes of Health, Bethesda.
Lappin
G L
GL
Science and Technology, Xceleron, Inc., Germantown, MD, USA.
Reed
N
N
Clinical Oncology, Beatson Oncology Centre, Glasgow, UK.
Palmeri
S
S
Medical Oncology, University of Palermo, Palermo, Italy.
Smyth
J
J
Medical Oncology, University of Edinburgh, Edinburgh, UK.
Embacher-Aichorn
S
S
Department of Internal Medicine/Medical Oncology, Medizinische Universität, Innsbruck, Austria.
Zwierzina
H
H
Department of Internal Medicine/Medical Oncology, Medizinische Universität, Innsbruck, Austria. Electronic address: Heinz.Zwierzina@i-med.ac.at.
D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D012108:Research Personnel
D000970:Antineoplastic Agents