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The Lost Art of Phase I Oncology Clinical Trials

The Lost Art of Phase I Oncology Clinical Trials

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Published by Medelis
Traditionally, oncology drug developers have regarded the phase I clinical trial as having a utility limited to the assessment of safety, tolerability, and pharmacokinetics and pharmacodynamics of a drug.

In this issue of "Peer Perspectives in Oncology," renowned oncology investigator Dr. Daniel Von Hoff describes how Chief Medical Officers can design better oncology phase I trials to glean meaningful efficacy data by using the patient as his or her own control. He further explains how a CMO can gather evidence showing a drug changes the natural history of a patient’s disease, demonstrating improved care and a stronger case for moving a drug into phase II.
Traditionally, oncology drug developers have regarded the phase I clinical trial as having a utility limited to the assessment of safety, tolerability, and pharmacokinetics and pharmacodynamics of a drug.

In this issue of "Peer Perspectives in Oncology," renowned oncology investigator Dr. Daniel Von Hoff describes how Chief Medical Officers can design better oncology phase I trials to glean meaningful efficacy data by using the patient as his or her own control. He further explains how a CMO can gather evidence showing a drug changes the natural history of a patient’s disease, demonstrating improved care and a stronger case for moving a drug into phase II.

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Published by: Medelis on Jan 12, 2009
Copyright:Attribution Non-commercial

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05/10/2014

 
Medelis, Inc.
4105 N 20th St Ste 215Phoenix, Arizona 85016Phone: 602.840.1101www.medelis.com
The Lost Opportunity inPhase I Oncology Trials
 A Q&A with renowned oncology investigator Daniel D. VonHoff, M.D., who advocates for a phase I approach that looksbeyond toxicity and gleans meaningful efficacy data, creatinga more compelling rationale for further investment andimproved patient care.
 
Medelis provides a full range of oncology contract research & drug developmentservices from preclinical through NDA. Download our abstracts or read our blog atwww.medelis.com.
WelcomeThis presentation is based on our December 2008issue of Peer Perspectives in Oncology,a free Q&A  series focused on issues that face Chief MedicalOfficers today: rising costs, optimum patient accrual,targeted therapeutics, patient safety, FDA regulations, efficacy, budgets, and timelines. You can sign up to receive an email notice for futureissues atwww.medelis.com/oncology_abstracts.html.
 
Medelis provides a full range of oncology contract research & drug developmentservices from preclinical through NDA. Download our abstracts or read our blog atwww.medelis.com.
The Lost Opportunity in Phase I Oncology Trials
Traditionally, drug developers have regarded the phase I trial ashaving a utility limited to the assessment of safety, tolerability,and pharmacokinetics and pharmacodynamics of a drug.In this issue of Peer Perspectives in Oncology, renownedoncology investigator Dr. Daniel Von Hoff describes how Chief Medical Officers can design better oncology phase I trials toglean meaningful efficacy data by using the patient as his or herown control.He further explains how a CMO can gatherevidence showing a drug changes the natural history of apatient’s disease, demonstrating improved care and a strongercase for moving a drug into phase II.

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