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

Annals of Oncology

Volumn 21, Issue 8, 2010, Pages 1573-1578

  Bergmann, L ^a   Berns, B ^b   Dalgleish, A G ^c   von Euler, M ^d   Hecht, T T ^e   Lappin, G L ^f   Reed, N ^g   Palmeri, S ^h   Smyth, J ⁱ   Embacher Aichorn, S ^j   Zwierzina, H ^j  

^a GOETHE UNIVERSITY   (Germany)

^b Janssen Research and Development   (United Kingdom)

^c ST GEORGE'S UNIVERSITY OF LONDON   (United Kingdom)

^d Pharma Development Clinical Oncology   (United Kingdom)

^e NATIONAL CANCER INSTITUTE   (United States)

^f Xceleron Inc   (United States)

^g BEATSON WEST OF SCOTLAND CANCER CENTRE   (United Kingdom)

^h UNIVERSITY OF PALERMO   (Italy)

ⁱ UNIVERSITY OF EDINBURGH   (United Kingdom)

^j INNSBRUCK MEDICAL UNIVERSITY   (Austria)

more..

Author keywords

Academic research; Clinical trials directive; Drug development; Investigator initiated trials; Oncology; Targeted therapies

Indexed keywords

ANTINEOPLASTIC AGENT; BIOLOGICAL MARKER; DENDRITIC CELL VACCINE; PROVENGE;

CANCER IMMUNOTHERAPY; CANCER THERAPY; CELL THERAPY; CLINICAL STUDY; DRUG DESIGN; DRUG EFFICACY; DRUG INDUSTRY; DRUG QUALITY; DRUG RESEARCH; DRUG SAFETY; DRUG SCREENING; FINANCIAL MANAGEMENT; HEALTH CARE POLICY; HUMAN; PRIORITY JOURNAL; PROSTATE CANCER; REVIEW; T LYMPHOCYTE;

EID: 77955254298     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdq018     Document Type: Review

References (40)

1. National Cancer Institute. The Nation's Investment in Cancer Research: Enhancing Investigator-Initiated Research. Bethesda, MD: National Institutes of Health 2005.
2. Hemminki A, Kellokumpu-Lehtinen PL. Harmful impact of EU clinical trials directive. BMJ 2006; 332: 501-502.
3. Goozner M. The $800 Million Pill: The Truth Behind the Cost of New Drugs. Berkeley, CA: University of California Press 2005.
4. Slamon DJ, Leyland-Jones B, Shak S et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001; 344: 783-792.
5. Jordan VC, Koerner S. Tamoxifen (ICI 46,474) and the human carcinoma 8S oestrogen receptor. Eur J Cancer 1975; 11: 205-206.
6. Druker BJ, Talpaz M, Resta DJ et al. Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia. N Engl J Med 2001; 344: 1031-1037.
7. Smith IC, Heys SD, Hutcheon AW et al. Neoadjuvant chemotherapy in breast cancer: significantly enhanced response with docetaxel. J Clin Oncol 2002; 20: 1456-1466.
8. Zerhouni EA. Research funding. NIH in the post-doubling era: realities and strategies. Science 2006; 314: 1088-1090.
9. Moses H III, Dorsey ER, Matheson DH, Thier SO. Financial anatomy of biomedical research. JAMA 2005; 294: 1333-1342.
10. Breimer L. Academia and industry-working together to fight cancer. IDrugs 2001; 4: 396-397.
11. Tralau-Stewart CJ, Wyatt CA, Kleyn DE, Ayad A. Drug discovery: new models for industry-academic partnerships. Drug Discov Today 2009; 14: 95-101.
12. Drummond MF, Mason AR. European perspective on the costs and cost-effectiveness of cancer therapies. J Clin Oncol 2007; 25: 191-195.
13. McCabe C, Bergmann L, Bosanquet N et al. Market and patient access to new oncology products in Europe: a current, multidisciplinary perspective. Ann Oncol 2009; 20: 403-412.
14. Margolin KA, van Besien K, Peace DJ. An introduction to foundation and industry-sponsored research: practical and ethical considerations. Hematology Am Soc Hematol Educ Program 2007; 2007: 498-503.
15. Weinberg R. A lost generation. Cell 2002; 126: 10.
16. Rowinsky EK. Erosion of the principal investigator role in a climate of industry dominance. Eur J Cancer 2005; 41: 2206-09.
17. Cutting Edge Information. Investigator-Initiated Trials: Building Superior IIT Capabilities. Durham, NC: Cutting Edge Information 2008.
18. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official J Eur Commun 2001; L121: 34-44.
19. Mayor S. Squeezing academic research into a commercial straitjacket. BMJ 2004; 328: 1036.
20. Sinha G. European move affects academic trials research. J Natl Cancer Inst 2006; 98: 1100-1101.
21. Gulland A. Number of global clinical trials done in UK fell by two thirds after EU directive. BMJ 2009; 338: b1052.
22. Fegert JM. Nicht kommerzielle Studien vor und nach der AMG Novellierung. Berlin, Germany: Universitatsklinikum Ulm 2006 Workshop Auswirkungen der 12 und 14.
23. Singer E. Future of investigator initiated trials in EU academia. Basic Clin Pharmacol Toxicol 2007; 101 (Suppl 1): 11.
24. Bok RA. Treatment of prostate cancer: therapeutic potential of targeted immunotherapy with APC8015. Ther Clin Risk Manag 2008; 4: 79-85.
25. Trimble EL, Abrams JS, Meyer RM et al. Improving cancer outcomes through international collaboration in academic cancer treatment trials. J Clin Oncol 2009; 27: 5109-5114.
26. IMS Health. Robust growth in specialist-driven products, including oncology treatments, reflect changing market dynamics. 2007 http://www.imshealth.com/portal/site/imshealth/menuitem.a46c6d4df3db4b3d88f611019418c22a/?vgnextoid=c16b1d3be7a29110VgnVCM10000071812ca2RCRD &vgnextchannel=41a67900b55a5110VgnVCM10000071812ca2RCRD&vgnextfmt=default (18 December 2008, date last accessed).
27. Takimoto CH. Phase 0 clinical trials in oncology: a paradigm shift for early drug development? Cancer Chemother Pharmacol 2008; 10: 10.
28. Eliopoulos H, Giranda V, Carr R et al. Phase 0 trials: an industry perspective. Clin Cancer Res 2008; 14: 3683-3688.
29. Workman P, Aboagye EO, Chung YL et al. Minimally invasive pharmacokinetic and pharmacodynamic technologies in hypothesis-testing clinical trials of innovative therapies. J Natl Cancer Inst 2006; 98: 580-598.
30. Lappin G, Garner RC. The utility of microdosing over the past 5 years. Expert Opin Drug Metab Toxicol 2008; 4: 1499-1506.
31. DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ 2003; 22: 151-185.
32. Zwierzina H, Liliemark J, deBock A. Pharmacoeconomics behind next-generation oncology drug development. Eur J Cancer 2007; 59 (Suppl): 2-9.
33. Walker I, Newell H. Do molecularly targeted agents in oncology have reduced attrition rates? Nat Rev Drug Discov 2009; 8: 15-16.
34. Schneider CK, Schaffner-Dallmann G. Typical pitfalls in applications for marketing authorization of biotechnological products in Europe. Nat Rev Drug Discov 2008; 7: 893-899.
35. National Cancer Institute. Immunotherapy Agent Workshop. Bethesda, MD: National Institutes of Health 2007.
36. Cheever MA. Twelve immunotherapy drugs that could cure cancers. Immunol Rev 2008; 222: 357-368.
37. Agenzia Italiana del Farmaco (AIFA). Independent Research on Drugs Funded by the Italian Medicines Agency. Rome, Italy: AIFA 2007 http://www.agenziafarmaco.it/wscs_render_attachment_by_id/tipo_file0109.pdf?id=111.109018.1188484620191&language=IT&lenient=false/(4 April 2009, date last accessed).
38. EUnetHTA (European Network for Health Technology Assessment). HTA definition. http://www.eunethta.net/HTA/(9 August 2006, date last accessed).
39. Paul JE, Trueman P. 'Fourth hurdle reviews', NICE, and database applications. Pharmacoepidemiol Drug Saf 2001; 10: 429-438.
40. ICREL. Conference on the Impact on Clinical Research of European Legislation-ICREL: Results and Discussion. Brussels, Belgium 2008.