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Electronic Letters to:

clinical trials:
F. Trotta, G. Apolone, S. Garattini, and G. Tafuri
Stopping a trial early in oncology: for patients or for industry?
Ann Oncol 2008; 19: 1347-1353 [Abstract] [Full text] [PDF]
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[Read eLetter] Stopping a trial early in oncology: a further element of discussion.
Antonio Jirillo   (27 May 2008)

Stopping a trial early in oncology: a further element of discussion. 27 May 2008
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Antonio Jirillo,
director
Istituto Oncologico Veneto IRCCS, Via Gattamelata 64 ,Padova 35128, Italy

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Re: Stopping a trial early in oncology: a further element of discussion.

The original article “Stopping a trial early in oncology: for patients or for industry” (1) offers to medical oncologists some topics for discussing about the conclusion of the article. After 2000 we have observed the increasing publication of articles for registration purposes as assessed by Authors through the interim analysis technique. For example the reported HERA trial (2) considering that one arm of the study was markedly over ( 951 versus 347 events) patients included in the control arm were allowed to received the experimental treatment. That cross-over of the patients could have affected the final analysis. In the particular case of HERA trial the great result of the study was even emphasized by media at the same time that the result was proposed to oncologists. Probably that case was one of the first situation that had forced oncologists to prescribe a therapy requested by patients themselves, even if the medical oncologist doubted about the reliability of the therapy. Moreover, the disclosure of the conflict of interest by Authors is a crucial point in every phase of the study. It is possible that at the start of the study an author does not declare to have conflict interest but after a positive interim analysis it is common that Industries sponsorized topic symposia to show the result to the oncology community. This fact is an additional element of concern in the final analysis of the study. Financial relationships between sponsors and investigators may bias research results (3). Furthermore in the clinical trials that did not have the presence of an Independent Committee should not have been considered for registration purposes.

References

1. Trotta, G. Apolone, S. Garattini, and G. Tafuri. Stopping a trial early in oncology: for patients or for industry? Ann Oncol 2008 ; April 9

2. Piccart-Gebhart MJ,Procter M,Leyland-Jones B et al.Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med 2005;353:1659-1672

3. Riechelmann RP, Wang L, O'Carroll A, Krzyzanowska MK. Disclosure of conflicts of interest by authors of clinical trials and editorials in oncology. J Clin Oncol. 2007 ;25:4642-4647.

Conflict of Interest:

None declared