Participation in phase 1 trials for patients with cancer

[...]the treatment-related death risk always remained below 1% in all periods and across all cancers, except pancreatic cancer. [...]the sample size of CTEP-sponsored phase 1 studies was usually lower than those of industry-sponsored studies, increasing the risk of bias due to sparse data. Because s...

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Bibliographische Detailangaben
Veröffentlicht in:The Lancet (British edition) Jg. 400; H. 10351; S. 473 - 475
1. Verfasser: Italiano, Antoine
Format: Journal Article
Sprache:Englisch
Veröffentlicht: England Elsevier Ltd 13.08.2022
Elsevier Limited
Schlagworte:
Cancer
Cancer therapies
Clinical trials
Clinical Trials, Phase I as Topic
Cytotoxicity
Drugs
FDA approval
Hematology
Human subjects
Humans
Medical research
Neoplasms - therapy
Oncology
Pancreatic cancer
Participation
Patient Participation
Patients
Pharmaceutical industry
Response rates
Tumors
United States > US
ISSN:0140-6736, 1474-547X, 1474-547X
Online-Zugang:Volltext
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Beschreibung
Zusammenfassung:[...]the treatment-related death risk always remained below 1% in all periods and across all cancers, except pancreatic cancer. [...]the sample size of CTEP-sponsored phase 1 studies was usually lower than those of industry-sponsored studies, increasing the risk of bias due to sparse data. Because several pharmaceutical companies made a commitment to provide access to deidentified patient-level data, future studies should focus on the trends in treatment-related deaths and response rates for patients enrolled in industry-sponsored phase 1 studies and on the variables associated with outcomes.
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ISSN:0140-6736
1474-547X
1474-547X
DOI:10.1016/S0140-6736(22)01533-1