Proportion of Patients in Phase I Oncology Trials Receiving Treatments That Are Ultimately Approved

cancer, biological markers, phase 1 clinical trials, drug approval, medical oncology, united states food and drug administration guidelines, adverse event, national comprehensive cancer network, American society of clinical oncology

Phase I oncology trials are often considered a therapeutic option, but this claim is primarily based on surrogate measures like objective response rates. A systematic search was conducted to evaluate the therapeutic value of phase I cancer trial participation, focusing on the likelihood of patien…

Apr 1^st • 14 mins read

Level of evidence used in recommendations by the National Comprehensive Cancer Network (NCCN) guidelines beyond Food and Drug Administration approvals

oncology, guidelines, off-label drug use

The analysis reviewed 113 NCCN recommendations, focusing on 44 off-label uses of drugs. 14 of these off-label recommendations were later FDA-approved or backed by RCT data. 13 recommendations were minor extrapolations from the FDA label or actually on-label. Of the remaining 17 extrapolations…

Aug 2^nd • 8 mins read

Association between control group therapy and magnitude of clinical benefit of cancer drugs

control group therapy, clinical benefit scales, ESMO-MCBS, ASCO-VF, randomized trials

The study investigated the impact of control group therapy on various clinical benefit scales like ASCO-VF, ESMO-MCBS, NCCN Evidence Blocks, and ASCO-CRC. Researchers analyzed cancer drugs approved between 2012 and 2021 using data from randomized controlled trials (RCTs) listed on Drugs@FDA. Sig…

Dec 9^th • 20 mins read