When an interim analysis of randomized trial changes the practice in oncology: the lesson of adjuvant Trastuzumab and the HERA trial

Autor:	Costanza De Rossi, Antonio Jirillo, Giuseppe Jirillo, Antonella Brunello
Rok vydání:	2010
Předmět:	Bridged-Ring Compounds Disease free survival medicine.medical_specialty medicine.medical_treatment Immunology Antineoplastic Agents Breast Neoplasms Toxicology Antibodies Monoclonal Humanized Disease-Free Survival Ethics Research law.invention Randomized controlled trial Adjuvants Immunologic Bias law Trastuzumab Internal medicine Interim Antineoplastic Combined Chemotherapy Protocols Immunology and Allergy Medicine Humans Anthracyclines Randomized Controlled Trials as Topic Pharmacology business.industry Antibodies Monoclonal General Medicine Interim analysis Surgery Treatment Outcome Research Design Chemotherapy Adjuvant Female Taxoids Hera trial Clinical Trials Data Monitoring Committees business Adjuvant medicine.drug
Zdroj:	Immunopharmacology and immunotoxicology. 31(1)
ISSN:	1532-2513
Popis:	About 30% of the randomized clinical trials are stopped early because of appearance of clear clinical benefit. Though interim analyses protect patients in case of significant imbalance between two treatment arms, conclusions drawn from truncated studies can be premature and should be viewed with caution. We report the lesson learnt from the Herceptin adjuvant (HERA) trial.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f7a6c913e85217c3d527768f1fe9817a https://pubmed.ncbi.nlm.nih.gov/21054206 Zobrazit plný text záznamu