Publication and Reporting Conduct for Pharmacodynamic Analyses of Tumor Tissue in Early Phase Oncology Trials
A partir de données portant sur 90 essais cliniques de phase précoce impliquant une biopsie invasive, sans intention diagnostique, pour l'analyse de caractéristiques pharmacodynamiques d'un médicament, cette étude analyse la fréquence de l'absence de données pharmacodynamiques dans les publications associées et en identifie les facteurs explicatifs
Purpose: In principle, nondiagnostic biopsies for pharmacodynamic (PD) studies are performed to inform decision-making in drug development. Because such procedures have no therapeutic value, their ethical justification requires that results be published. We aimed to assess the frequency of non-publication of PD data in early phase cancer trials and to identify factors that prevent full publication of data. Methods: We identified a sample of early phase cancer trials containing invasive nondiagnostic tissue procurement for PD analysis from ASCO and AACR meeting abstracts published between 1995-2005. These trials were followed to publication to determine frequency of non-publication of PD data. Corresponding authors on early phase cancer trials employing invasive nondiagnostic research procedures were also surveyed to identify factors preventing full publication of PD data. Results: In a sample of 90 trials, 22.2% (20 trials) resulted in no trial publication. Of published trials expected to contain PD reports, 16 (17.8%) did not include any PD data, and 21 (23.3%) reported incomplete PD data. We surveyed 92 authors; nonpublication was regarded as a frequent occurrence, and the most commonly cited barrier to full publication of PD data was strategic considerations in publication (58.8% of responding authors). Conclusion: Our results suggest ways that investigators, study planners, and reviewers can improve the burden / knowledge value balance in PD studies.
Clinical Cancer Research , résumé, 2012