The Burgeoning Use of Surrogate End Points Creates a Significant Need to Identify New Biomarkers - Challenges in Oncology Clinical Trial Design
Posted on: Monday, 2 April 2007, 15:00 CDT
Research and Markets (http://www.researchandmarkets.com/reports/c53188) has announced the addition of Challenges in Oncology Clinical Trial Design to their offering.
The ongoing evolution of cancer therapeutics and the associated increase in survival times have prompted a re-evaluation of traditional methodology in the design and conduct of oncology clinical trials. These changes have led to increasing complexity in clinical trials as well as new operational and design challenges for researchers and drug developers.
Get the Answers You Need to Shape Your Strategy
As cancer treatments improve and survival rates for many types of cancer increase, drug developers need to differentiate their agents using metrics other than increased survival.
What are the most effective new end points for developers to use in clinical trials?
Drug developers are increasingly using surrogate end points to establish their oncology agents' efficacy. What are the benefits of using these surrogate end points? Do regulators support the use of surrogates or will pharma companies face regulatory challenges?
The burgeoning use of surrogate end points creates a significant need to identify new biomarkers. What initiatives are now under way to stimulate oncology biomarker validation efforts?
What incentive will pharma companies have to pursue development of these markers rather than viewing this approach as a significant business risk?
Scope
Background on oncology clinical trials: changes in cancer treatment and FDA guidelines, current end points used.
Challenges in oncology clinical trials: choosing appropriate end points and managing data complexity, randomization design, operational challenges, safety, and recruitment.
Case studies: Novartis's Gleevec and Genentech's Tarceva.
Surrogate end points: benefits to drug developers, need for new biomarkers.
Content Outline:
Executive Summary
Strategic Considerations
Stakeholder Implications
Introduction
Background on Oncology Clinical Trials
Changes in Cancer Treatment and FDA Guidelines
Current End Points
Survival
Response Rate in Solid Tumors
Time to Progression
Composite Clinical Benefit End Points
Quality of Life
Challenges in Oncology Clinical Trials
Choosing Appropriate End Points and Managing Data Complexity
Randomization Design
Operational Challenges
Safety
Recruitment
Case Studies
Novartis's Gleevec
Genentech's Tarceva
Trends in Oncology Trials--Surrogate End Points and Biomarkers
Tables
1. Targeted Therapeutics Approved for the Treatment of Cancer
2. Commonly Used End Points in Oncology Clinical Trials
3. Response Evaluation Criteria in Solid Tumors (RECIST)
4. Select FDA-Approved Companion Diagnostics
Figures
1. Average Response Rates to "One-Size-Fits-All" Drugs
Abbott Laboratories
Amgen
Bayer
BioGenex
Bristol-Myers Squibb
Chugai
DakoCytomation
Eli Lilly
Genentech
Ilex Partners
ImClone
Merck KGaA
Millennium
Novartis
OSI Pharmaceuticals
Parexel
Pfiizer
RadPharm
Roche
Seragen
Third Wave Technologies
Ventana
Vysis
Wako
Wyeth
For more information visit http://www.researchandmarkets.com/reports/c53188
Source: Decision Resources
Source: Business Wire
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