Annals of Oncology Advance Access first published online on February 27, 2008
This version published online on April 9, 2008
Annals of Oncology, doi:10.1093/annonc/mdn042
Stopping a trial early in oncology: for patients or for industry?
1 Italian Medicines Agency (AIFA), Rome
2 Mario Negri Institute for Pharmacological Research, Milan, Italy
3 Utrecht University, UIPS Institute for Drug Innovation, Utrecht, The Netherlands
* Correspondence to: Dr G. Tafuri, Italian Medicines Agency (AIFA), via della Sierra Nevada 60, 00144 Rome, Italy. Tel: +39 6 59784713, Fax: +39 6 59784717; E-mail: g.tafuri{at}aifa.gov.it
Background: The aim of this study is to assess the use of interim analyses in randomised controlled trials (RCTs) testing new anticancer drugs, focussing on oncological clinical trials stopped early for benefit.
Materials and methods: All published clinical trials stopped early for benefit and published in the last 11 years, regarding anticancer drugs and containing an interim analysis, were assessed.
Results: Twenty-five RCTs were analysed. The evaluation of efficacy was protocol planned through time-related primary end points, >40% of them overall survival. In 95% of studies, at the interim analysis, efficacy was evaluated using the same end point as planned for the final analysis. As a consequence of early stopping after the interim analysis, 
3300 patients/events across all studies were spared. More than 85% of the RCTs published in the last 3 years were used for registration purposes.
Conclusion: Though criticism of the poor quality of oncological trials seems out of place, unfortunately early termination raises new concerns. The relation between sparing patients and saving time and trial costs indicates that there is a market-driven intent. We believe that only untruncated trials can provide a full level of evidence which can be translated into clinical practice without further confirmative trials.
anticancer drugs, EMEA, FDA, end point, interim analysis, RCT
Received for publication December 18, 2007. Revision received January 25, 2008. Accepted for publication January 28, 2008.
CiteULike 
Connotea 
Del.icio.us What's this?
This article has been cited by other articles:
|
|
 |
|
  E. L. Korn, B. Freidlin, and M. Mooney Stopping or Reporting Early for Positive Results in Randomized Clinical Trials: The National Cancer Institute Cooperative Group Experience From 1990 to 2005 J. Clin. Oncol., April 1, 2009; 27(10): 1712 - 1721. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 S. Garattini and I. Chalmers Patients and the public deserve big changes in evaluation of drugs BMJ, March 31, 2009; 338(mar31_3): b1025 - b1025. [Full Text]
|
|
|
|
 |
|
 P. Bradbury, R. Meyer, J. Pater, D. Tu, L. Seymour, L. Shepherd, and E. Eisenhauer Stopping a trial early in oncology: for patients or for industry? Ann. Onc., February 1, 2009; 20(2): 395 - 396. [Full Text] [PDF]
|
|
|
|
|
|
J. Whitehead and E. Cobo Stopping a trial early in oncology: for patients or for industry? Ann. Onc., August 1, 2008; 19(8): 1512 - 1513. [Full Text] [PDF]
|
|
E-letters:
Read all E-letters
- Stopping a trial early in oncology: a further element of discussion.
- Antonio Jirillo
- Annals of Oncology, 27 May 2008 [Full text]