{"doi":"10.1001/jamanetworkopen.2021.17826","title":"Assessing Clinical Outcomes in a Data-Rich World—A Reality Check on Real-World Data","abstract":"Advancements in health information technology and data aggregation have led to the emergence of real-world data and real-world evidence (RWE). The 21st Century Cures Act 1 broadly defined RWE as \"data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than randomized clinical trials\" and required the US Food and Drug Administration (FDA) to create a program for RWE for expanding indications and postapproval study. In oncology, retrospective RWE generated from electronic health records has had demonstrable impacts in regulatory approval, leading to the FDA-accelerated approval of blinatumomab and expanded indication for palbociclib based on surrogate end points. Kehl et al 2 report their assessment of surrogate end points in a large, multi-institutional cohort of patients with genomically sequenced non-small cell lung cancer and colorectal cancer. Overall, they demonstrated a limited correlation between time to treatment discontinuation and time to next treatment and overall survival (OS). Progression-free survival (PFS) based on imaging reports and Downloaded From: https://jamanetwork.com/ on 08/20/2023 supports new opportunities for advanced clinical decision support and novel end points in randomized clinical studies.","journal":"JAMA Network Open","year":2021,"id":209490,"datarank":0.25973604258088656,"base_score":1.3862943611198906,"endowment":1.3862943611198906,"self_citation_contribution":0.20794415416798362,"citation_network_contribution":0.051791888412902914,"self_endowment_contribution":0.20794415416798362,"citer_contribution":0.051791888412902914,"corpus_percentile":null,"corpus_rank":null,"citation_count":3,"citer_count":2,"citers_with_citation_signal":2,"citers_with_endowment":2,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.6012,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2021-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":51,"name":"Atul Janardhan Butte","orcid":"0000-0002-7433-2740","position":1,"is_corresponding":false},{"id":53178,"name":"Julian C. Hong","orcid":"0000-0001-5172-6889","position":0,"is_corresponding":true}],"reference_count":6,"raw_metadata":{"citation_network_status":"fetched"},"created_at":"2026-07-18T23:52:05.171356Z","pmid":"34309673","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}