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Assessing the quality of phase I clinical trial abstracts
Date:10/21/2008

velopment focus of the ENA symposia. There remains room for improvement in both conferences for improving abstract quality and we believe this may be achieved by adopting guidelines for reporting on phase 1 clinical trials."

Dr Ho and his colleagues have drawn up a list of what they believe should be included in any guidelines on reporting phase I trials. The following are items that are absolutely essential:

  • Description of dose-limiting toxicity encountered on study
  • Conclusion explicitly states maximum tolerated doses (MTD) or residual disease (RD) or reason for early trial closure
  • Description of grade three toxicity and above that may be related to study drug
  • Description of drug delivery schedule or formulation
  • Number of patients on study
  • Title identifying study as dose finding or phase I
  • Pharmacokinetic analysis, if applicable

The following items should also be reported:

  • Explicit definition of primary end point or objective
  • Rationale for study
  • Pharmacodynamic results, if applicable
  • Current status of study
  • Information related to treatment cycles
  • Efficacy outcome of patients
  • Number of patients at each dose level
  • Tumour types of responders, if applicable

Dr Ho said: "We are not aware of any such guidelines in existence. We are hoping that our suggestions for guidelines can be validated further and then put into clinical use, for instance, as recommendations and reference guide to clinical researchers to help them with abstract writing, and maybe also as guidelines for conferences to evaluate abstracts being submitted."

Abstracts at both conferences improved in quality the more recently they were presented, possibly indicating that authors were becoming more aware of what information needed to be included.

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Contact: Emma Mason
wordmason@mac.com
41-227-612-105
ECCO-the European CanCer Organisation
Source:Eurekalert

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