92P Utilizing pre-clinical and clinical pharmacokinetics data to identify novel interspecies conversion factors for the development of mAbs based on the NOAEL method

Background: Cancer is a major global health challenge requiring effective treatments to prevent recurrence.Adjuvant cancer therapy, administered post-primary treatment, significantly reduces relapse risk.However, many clinical trials investigating these therapies are discontinued or unpublished, diminishing their contribution to patient care and evidence-based practice.This study examines the rates, causes, and predictors of trial discontinuation and nonpublication.Methods: This cross-sectional study analyzed data from ClinicalTrials.gov as of November 6, 2024.Trials related to adjuvant cancer therapy were identified using relevant search terms.Inclusion criteria included trials categorized by recruitment status as "Completed," "Suspended," "Terminated," or "Withdrawn," while other trials were excluded.Adjusted logistic regression was performed to assess trial characteristics influencing completion and publication status.Results: Of 1838 trials, 707 (38.5%) were analyzed, with 529 (74.8%) completed and 178 (25.2%) discontinued.Among completed trials, 37.6% were unpublished, while 68% of discontinued trials remained unpublished.Drug-only interventions were most common (29.4%), with 51.9% unpublished.Combination therapies (4.1%) had higher unpublished rates (58.6%).Trials involving both sexes accounted for 65.6%, with 45.3% unpublished, while 62.4% targeted adults and older adults.Multi-center trials (47.1%) had better publication rates, while single-center trials (42.9%) had higher unpublished rates (49.5%).Non-industrial funding supported 76.9%, with 24.4% discontinued.Larger enrollment reduced discontinuation risk (p < 0.001), while nonindustrial funding lowered publication odds (p 0.021).Conclusions: A substantial proportion of adjuvant cancer therapy trials remain unpublished, particularly those involving single-center designs, drug-only interventions, and non-industrial funding.Addressing publication gaps through enhanced trial designs, increased industrial collaboration, and effective dissemination strategies is essential to maximize the clinical impact of these studies.