Time to mandate data release and independent audits for all clinical trials

Ian E Haines and George L Gabor Miklos
Med J Aust 2011; 195 (10): . || doi: 10.5694/mja11.10599
Published online: 21 November 2011

As a condition of publication of phase III clinical trials, medical journals should insist on the release of all raw data and a written independent clinical audit

Editorials and commentaries in some high-profile journals herald an upcoming revolution in personalised oncology.1 However, any new treatment can only be considered an advance if it:

  • 1 Medical Oncology and Palliative Care, Cabrini Health, Melbourne, VIC.
  • 2 Secure Genetics, Sydney, NSW.


Competing interests:

No relevant disclosures.

  • 1. Cancer: the revolution has begun [editorial]. Lancet 2010; 376: 1117.
  • 2. Lemmens T. Leopards in the temple: restoring scientific integrity to the commercialized research scene. J Law Med Ethics 2004; 32: 641-657.
  • 3. US Food and Drug Administration. FDA Briefing document Oncology Drug [sic] Advisory Committee Meeting. December 5, 2007. BLA STN 125085/91.018. Avastin (bevacizumab). (accessed Oct 2011).
  • 4. D’Agostino RB Sr. Changing end points in breast-cancer drug approval — the Avastin story. N Engl J Med 2011; 365: e2.
  • 5. Carpenter D, Kesselheim AS, Joffe S. Reputation and precedent in the bevacizumab decision. N Engl J Med 2011; 365: e3.
  • 6. Ocana A, Amir E, Eisenhauer EA, et al. Addition of bevacizumab to chemotherapy for treatment of solid tumors: similar results but different conclusions. J Clin Oncol 2011; 29: 254-256.
  • 7. Miller K, Wang M, Gralow J, et al. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med 2007; 357: 2666-2676.
  • 8. Haines IE, Miklos GLG. Paclitaxel plus bevacizumab for metastatic breast cancer [letter]. N Engl J Med 2008; 358: 1637-1638.
  • 9. Miller KD, Chap LI, Holmes FA, et al. Randomised phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. J Clin Oncol 2005; 23: 792-799.
  • 10. Miles DW, Chan A, Dirix LY et al. Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth-factor receptor 2-negative metastatic breast cancer. J Clin Oncol 2010; 28: 3239-3247.
  • 11. Robert NJ, Dieras V, Glaspy J, et al. RIBBON-1: randomised, double-blind, placebo-controlled, phase iii trial of chemotherapy with or without bevacizumab for first-line treatment of human epidermal growth factor receptor 2-negative, locally recurrent or metastatic breast cancer. J Clin Oncol 2011; 29: 1252-1260.
  • 12. Burstein HJ. Bevacizumab for advanced breast cancer: all tied up with a RIBBON? J Clin Oncol 2011; 29: 1232-1235.
  • 13. Pushing the envelope [editorial]. Nat Biotechnol 2011; 29: 669.
  • 14. Van Cutsem E, Köhne CH, Hitre E, et al. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med 2009; 360: 1408-1417.
  • 15. Roila F, Garassino MC, Ballatori E. Cetuximab for metastatic colorectal cancer [letter]. N Engl J Med 2009; 361: 95-97.
  • 16. Hallek M, Fischer K, Fingerle-Rowson G, et al. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial. Lancet 2010; 376: 1164-1174.
  • 17. Salles G, Seymour JF, Offner F, et al. Rituximab maintenance for 2 years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a phase 3 randomised controlled trial. Lancet 2011; 377: 42-51.
  • 18. Haines I, Elliott P, Stanley R. Rituximab-containing therapy for chronic lymphocytic leukaemia [letter]. Lancet 2011; 377: 205-206.
  • 19. Haines I. Rituximab maintenance therapy for follicular lymphoma [letter]. Lancet 2011; 377: 1151-1152.
  • 20. Friedberg JW. Rituximab maintenance in follicular lymphoma: PRIMA. Lancet 2011; 377: 4-6.
  • 21. Cuzick J, Sestak I, Baum M, et al. Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 10-year analysis of the ATAC trial. Lancet Oncol 2010; 11: 1135-1141.
  • 22. Tannock I. 10-year analysis of the ATAC trial: wrong conclusion? Lancet Oncol 2011; 12: 216-217.
  • 23. Raymond E, Dahan L, Raoul JL, et al. Sunitinib malate for the treatment of pancreatic neuroendocrine tumors. N Engl J Med 2011; 364: 501-513.
  • 24. Yao JC, Shah MH, Ito T, et al. Everolimus for advanced pancreatic neuroendocrine tumours. N Engl J Med 2011; 364: 514-523.
  • 25. Machiels JP, Subramanian S, Ruzsa A, et al. Zalutumumab plus best supportive care versus best supportive care alone in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck after failure of platinum-based chemotherapy: an open-label, randomised phase 3 trial. Lancet Oncol 2011; 12: 333-343.
  • 26. de Boer RH, Arrieta Ó, Yang CH, et al. Vandetanib plus pemetrexed for the second-line treatment of advanced non-small cell lung cancer: a randomized, double-blind phase III trial. J Clin Oncol 2011; 29: 1067-1074.
  • 27. Pharmaceutical Benefits Scheme, Australian Government Department of Health and Ageing. PBS Schedule search. (accessed Oct 2011).
  • 28. Pollack A. Approval for drug that treats melanoma. New York Times 2011; 25 Mar. (accessed Oct 2011).
  • 29. Katelaris AG. Research fraud — where to from here? Med J Aust 2011; 194: 619. <MJA full text>
  • 30. Smith R. Medical journals are an extension of the marketing arm of pharmaceutical companies. PLoS Med 2005; 2: e138.


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