Data collection in cancer clinical trials: Too much of a good thing?

BackgroundSubstantial staff time and costs are incurred in the collection of data for cancer clinical trials. Anecdotal experience suggests that much of these data are never used in the analysis or reporting of a trial.PurposeTo quantify data items collected in cancer clinical trials and calculate what percentage is used in subsequent published manuscripts.MethodsCancer clinical trials completed by the Ontario Clinical Oncology Group (OCOG) between 2003 and 2012 and the corresponding primary outcome publication were identified. The number of data items collected on each trial’s case report form (CRF) was counted and sorted into 18 categories including eligibility, baseline characteristics, medical history, toxicity, and recurrence. The data items were then counted within the corresponding published manuscripts to determine percent of data used overall and within each section.ResultsIn all, 8 trials, with 9 corresponding publications, were evaluated. The CRF analysis revealed that the total collected items...