NDLI: Safety biomarkers and the clinical development of oncology therapeutics: Considerations for cardiovascular safety and risk management

Content Provider	Springer Nature Link
Author	Fingert, Howard Varterasian, Mary
Copyright Year	2006
Abstract	During the clinical development of oncology therapeutics, new safety biomarkers are being employed with broad applications and implications for risk management and regulatory approval. Clinical laboratory results, used as safety biomarkers, can influence decision making at many levels during the clinical development and regulatory review of investigational cancer therapies, including (1) initial eligibility for protocol therapy; (2) analyses used to estimate and characterize the safety profile; and (3) treatment delivery, based on specific rules to modify or discontinue protocol treatment. With the increasing applications of safety biomarkers in clinical studies, consideration must be given to possible unintended consequences, including (1) restricted access to promising treatments; (2) delays in study completion; and (3) limitations to dose delivery, escalation, and determination of the maximal tolerated dose, the recommended phase 2 dose, and the optimal biologic dose selected for registration studies. This review will compare and contrast 2 biomarkers for cardiac safety that are employed in an increasing number of clinical programs designed for investigational oncology therapeutics: (1) assessment of left ventricular ejection fraction by either echocardiography or multigated acquisition scan; and (2) electrophysiological measurement of QT/QTc duration, assessed by electrocardiogram, for predicting risk of a potentially fatal arrhythmia called torsades de pointes. While these and other new safety biomarkers have major value in the development of oncology therapeutics, their applications require careful consideration to avoid unintended consequences that could negatively affect (1) the care of patients with advanced malignancy and (2) the advancement of promising new agents.
Starting Page	E89
Ending Page	E94
File Format	PDF
ISSN	12341234
Journal	The AAPS Journal
Volume Number	8
Issue Number	1
e-ISSN	15507416
Language	English
Publisher	Springer New York
Publisher Date	2006-03-01
Publisher Institution	American Association of Pharmaceutical Scientists
Publisher Place	New York
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Safety biomarkers oncology therapeutics risk management cardiotoxicity Pharmacology/Toxicology Biochemistry Biotechnology Pharmacy
Content Type	Text
Resource Type	Article

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1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
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