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In Reply

PSI International Inc, Fairfax, VA

A. Dimitrios Colevas

Cancer Therapy Evaluation Program, National Cancer Institute, Rockville, MD

We appreciated Dr Extermann’s comments on the reporting of hematologic adverse events, and we agree that there should be more transparent reporting of the methodologies used concerning blood count assays for clinical trials. In the Bear et al article,² no information for the prospective active collection of any adverse event data is discussed, nor is the adverse event lexicon used specified. In the Nabholtz et al article,³ weekly blood counts are specified and they cite a plan to assess other adverse events "on day 1 before therapy." Therefore, for lack of more informative data, the difference in neutropenia may be the result of very few of the patients in one trial having any blood counts taken or because of different grading criteria. Equally absent are plans to measure other relevant blood chemistries and the plans for a balanced assessment of neuropathy. These two examples are representative of our experience with adverse event reporting in randomized controlled cancer trials.

We agree that all clinical trial manuscripts should include a specific reference to the adverse event evaluation methodology, but this reference should not be limited to blood count evaluations. We are not certain that one template will be suitable for most situations. We would rely on the insight and experience of the clinical investigators to tailor the data collection and presentation plans to the specific needs of the article. This planning is not trivial, for there is an increasing demand from regulators and pharmaceutical company sponsors for more data collection, with little regard to the resource utilization consequences these demands impose. Investigators need to take a stand on how much data collection is sufficient to ensure the validity of the trial results and safety of trial participants. However, when significant data discrepancies between clinical trials databases and what is represented in trial manuscripts are uncovered,¹ it is difficult for the manuscript reader to trust that what the investigators have published represents a true picture of the adverse event data. This distrust could possibly legitimize collection of data beyond what would be sufficient were the data sets consistent. We are unaware of any publicly available comparisons between the adverse event data in a sponsor’s database and the published trial’s adverse events for phase III trials conducted by cooperative groups² such as the NSABP, or ad hoc pharmaceutical industry–sponsored clinical trial consortia such as the TAX 306 Study Group.³ We encourage journal editors to develop an efficient and rigorous process to ensure that the adverse event data presented in articles are consistent with the data collected and held by the investigators, and that the methodology for collection, synthesis, and presentation of those data is made available to the readers. It is only after this issue is addressed that one can legitimize the claim that we are possibly collecting and presenting too much nonessential data, and that the resources used for doing so are therefore wasted.

AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

The authors indicated no potential conflicts of interest.

REFERENCES

1. Scharf O, Colevas AD: Adverse event reporting in publications compared with sponsor database for cancer clinical trials. J Clin Oncol 24:3933-3938, 2006[Abstract/Free Full Text]

2. Bear HD, Anderson S, Brown A, et al: The effect on tumor response of adding sequential preoperative docetaxel to preoperative doxorubicin and cyclophosphamide: Preliminary results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol 21:4165-4174, 2003[Abstract/Free Full Text]

3. Nabholtz JM, Falkson C, Campos D, et al: Docetaxel and doxorubicin compared with doxorubicin and cyclophosphamide as first-line chemotherapy for metastatic breast cancer: Results of a randomized, multicenter, phase III trial. J Clin Oncol 21:968-975, 2003[Abstract/Free Full Text]

Related Correspondence

• More Thoughts on the Reporting of Adverse Events in Cancer Clinical Trials
  Martine Extermann
  JCO 2007 25: 918 [Full Text]

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