Design of phase III trials with long-term survival outcomes based on short-term binary results.
Sign Up to like & getrecommendations! Published in 2021 at "Statistics in medicine"
DOI: 10.1002/sim.9018
Abstract: Pathologic complete response (pCR) is a common primary endpoint for a phase II trial or even accelerated approval of neoadjuvant cancer therapy. If granted, a two-arm confirmatory trial is often required to demonstrate the efficacy… read more here.
Keywords: iii trials; phase iii; term; survival ... See more keywords
Adoption of multiple primary endpoints in phase III trials of systemic treatments in patients with advanced solid tumours. A systematic review.
Sign Up to like & getrecommendations! Published in 2021 at "European journal of cancer"
DOI: 10.1016/j.ejca.2021.03.007
Abstract: BACKGROUND AND AIM Trial designs using multiple primary endpoints (MPEs) are increasing in phase III cancer trials. Our objectives were to describe the incidence of MPEs in recently published phase III trials testing systemic treatments in… read more here.
Keywords: iii trials; patients advanced; phase iii; primary endpoints ... See more keywords
Deficiencies in health-related quality-of-life assessment and reporting: a systematic review of oncology randomized phase III trials published between 2012 and 2016
Sign Up to like & getrecommendations! Published in 2018 at "Annals of Oncology"
DOI: 10.1093/annonc/mdy449
Abstract: Quality of life (QoL) is a relevant end point and a topic of growing interest by both scientific community and regulatory authorities. Our aim was to review QoL prevalence as an end point in cancer… read more here.
Keywords: end; iii trials; qol results; phase iii ... See more keywords
Pre-existing evidence and outcome of phase III trials in gastrointestinal oncology: a systematic review.
Sign Up to like & getrecommendations! Published in 2023 at "Journal of the National Cancer Institute"
DOI: 10.1093/jnci/djad030
Abstract: BACKGROUND A minority of phase III trials in gastrointestinal oncology are positive. We assessed the association between their outcome, and the level and characteristics of pre-existing evidence. METHODS EMBASE, PubMed, and proceedings from international meetings… read more here.
Keywords: oncology; iii trials; evidence; phase ... See more keywords
Clinical trials in systemic lupus erythematosus: the dilemma—Why have phase III trials failed to confirm the promising results of phase II trials?
Sign Up to like & getrecommendations! Published in 2022 at "Annals of the Rheumatic Diseases"
DOI: 10.1136/ard-2022-222839
Abstract: Systemic lupus erythematosus (SLE) is an autoimmune rheumatic disease of unknown aetiology, characterised by the production of auto-antibodies and formation of immune complexes against self-antigens and complement activation. This inflammatory response can lead to tissue… read more here.
Keywords: iii trials; systemic lupus; phase trials; phase ... See more keywords
The Impact of Early-Phase Trial Design in the Drug Development Process
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DOI: 10.1158/1078-0432.ccr-18-0203
Abstract: Purpose: Many of the therapeutic agents that are being used currently were developed using the 3+3 decision rule for dose finding. Over the past 30 years, several dose-finding designs have been proposed and evaluated, including… read more here.
Keywords: phase; early phase; iii trials; phase iii ... See more keywords
Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non–Small-Cell Lung Cancer
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DOI: 10.1200/jco.20.01605
Abstract: PURPOSE Immunotherapy has revolutionized the treatment of advanced non–small-cell lung cancer (NSCLC). In two phase III trials (CheckMate 017 and CheckMate 057), nivolumab showed an improvement in overall survival (OS) and favorable safety versus docetaxel… read more here.
Keywords: iii trials; phase iii; checkmate 017; previously treated ... See more keywords
Factors Influencing the Efficacy of COVID-19 Vaccines: A Quantitative Synthesis of Phase III Trials
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DOI: 10.3390/vaccines9040341
Abstract: To date, there is still a paucity of data from Phase III trials concerning the efficacy of vaccines against COVID-19. Furthermore, no studies investigated the variables that may modulate the efficacy of vaccination. The aim… read more here.
Keywords: covid vaccines; quantitative synthesis; efficacy; iii trials ... See more keywords