Document Detail

'No risk, no fun': challenges for the oncology phase I clinical trial time-performance.
MedLine Citation:
PMID:  18951015     Owner:  NLM     Status:  MEDLINE    
Drug development in oncology is faced with the challenge of making active new compounds available for standard of care in the shortest possible time frame. While rules and regulations create an accepted factor in delaying trial execution, protocol issues and procedures are more often a delay factor than needed, particularly in industry-sponsored studies. This provides an option to decrease trial time, without affecting patient safety. Among the possible rooms for improvement are a balanced use of in- and exclusion criteria, justified by animal toxicology, and flexible dose escalation steps still defined a priori. It is also of crucial importance to make sure in the phase I programme that the pharmacology of the agent involved is appropriately understood. Including real-time pharmacokinetics, food-effect studies and, if possible, bioavailability studies in the phase I programme would decrease the risk of taking the wrong decisions for follow-on development. The concept of increasing the number of study sites to speed up accrual has a negative effect on trial execution and is actually a delay factor that in addition has the intrinsic risk of putting patient safety at stake.
Jaap Verweij
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Publication Detail:
Type:  Journal Article     Date:  2008-10-22
Journal Detail:
Title:  European journal of cancer (Oxford, England : 1990)     Volume:  44     ISSN:  1879-0852     ISO Abbreviation:  Eur. J. Cancer     Publication Date:  2008 Nov 
Date Detail:
Created Date:  2008-11-10     Completed Date:  2009-03-16     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9005373     Medline TA:  Eur J Cancer     Country:  England    
Other Details:
Languages:  eng     Pagination:  2600-7     Citation Subset:  IM    
Department of Medical Oncology, Erasmus University Medical Center, Rotterdam, The Netherlands.
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MeSH Terms
Antineoplastic Agents / adverse effects,  pharmacokinetics,  therapeutic use*
Biological Availability
Clinical Protocols
Clinical Trials, Phase I as Topic / methods*
Dose-Response Relationship, Drug
Food-Drug Interactions
Maximum Tolerated Dose
Neoplasms / drug therapy*
Tumor Markers, Biological
Reg. No./Substance:
0/Antineoplastic Agents; 0/Tumor Markers, Biological

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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