Publication and reporting conduct for pharmacodynamic analyses of tumor tissue in early-phase oncology trials.
OBJECTIVE
In principle, nondiagnostic biopsies for pharmacodynamic (PD) studies are carried out 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 nonpublication 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 American Society of Clinical Oncology and American Association for Cancer Research meeting abstracts published between 1995 and 2005. These trials were followed to publication to determine frequency of nonpublication of PD data. Corresponding authors on early-phase cancer trials using 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).


CONCLUSIONS
Our results suggest ways that investigators, study planners, and reviewers can improve the burden/knowledge value balance in PD studies.
Biomedical Ethics Unit, Department of Experimental Medicine, Department of Social Studies of Medicine, McGill University, Montreal, Quebec, Canada.
Georgina A
GA
Freeman
Jonathan
J
Kimmelman
D000970:Antineoplastic Agents / Q000494:pharmacology*; D001706:Biopsy / Q000941:ethics; D002986:Clinical Trials as Topic / Q000592:standards; D006801:Humans; D009369:Neoplasms / Q000473:pathology; D011642:Publications / Q000592:standards / Q000706:statistics & numerical data; D058028:Research Report / Q000592:standards; D011795:Surveys and Questionnaires
D000970:Antineoplastic Agents