{"doi":"10.1200/jco.23.01976","title":"Patient Experience, Adverse Event Reporting, and Clinical Trial Design","abstract":null,"journal":"Journal of Clinical Oncology","year":2024,"id":636062,"datarank":0.31191623125197543,"base_score":2.0794415416798357,"endowment":2.0794415416798357,"self_citation_contribution":0.31191623125197543,"citation_network_contribution":0.0,"self_endowment_contribution":0.31191623125197543,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":7,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":317124,"name":"Heather B. Neuman","orcid":"0000-0001-7462-8333","position":0,"is_corresponding":false}],"reference_count":0,"raw_metadata":{"has_enrichment":true,"resolved":true,"title":"Patient Experience, Adverse Event Reporting, and Clinical Trial Design","abstract":"Although grade 1 and 2 adverse events (AEs) are relevant to patients' day-to-day experiences with treatment, investigators designing studies need to have a thoughtful approach with significant stakeholder engagement to decide whether, which ones, and when to collect lowgrade AEs.In the article that accompanies this editorial, O'Connell et al 1 present a secondary analysis of the phase III ECOG ACRIN E1912 trial designed to determine the relationship between low-/ moderate-grade adverse events (AEs) and patients' treatment experience and treatment discontinuation.The authors report that low-/moderate-grade AEs, especially those that patients describe as symptomatic, are associated with both patient-reported side effect bother and treatment discontinuation.The authors conclude that the standard approach of limiting AE reporting to grade 3 events or higher does not fully reflect patients' experience with treatment.The authors argue that \"fully understand[ing] treatment tolerability and toxicity burden\" 1 is imperative, especially given the growing number of oral targeted agents and immunotherapies that may be taken over extended periods of time.Clinical trials are critical to advancing cancer care.However, conducting cancer trials is expensive and time-consuming.Current efforts at the National Center Institute are focused on how to more efficiently conduct cancer research and accelerate the development of life-saving cancer interventions. 6,7At the same time, investigators recognize the importance of enrolling diverse populations from varying clinical settings to have generalizable trial results. 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