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SUMMARY
Introduction
The ongoing evolution of cancer therapeutics and the associated increase in
survival times have prompted a reevaluation 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.
Mentioned in This Spectrum Report:
Companies
- Abbott Laboratories
- Amgen
- Bayer
- BioGenex
- Bristol-Myers Squibb
- Chugai
- DakoCytomation
- Eli Lilly
- Genentech
- Ilex Partners
- ImClone
- Merck KGaA
- Millennium
- Novartis
- OSI Pharmaceuticals
- Parexel
- Pfi zer
- RadPharm
- Roche
- Seragen
- Third Wave Technologies
- Ventana
- Vysis
- Wako
- Wyeth
Products
- Aredia (pamidronate)
- Avastin (bevacizumab)
- Campath (alemtuzumab)
- Camptosar (irinotecan)
- Erbitux (cetuximab)
- Gemzar (gemcitabine)
- Gleevec (imatinib mesylate)
- Herceptin (trastuzumab)
- Mylotarg (gemtuzumab ozogamicin)
- Nexavar (sorafenib)
- Ontak (denileukin difi tox)
- Rituxan (rituximab)
- Sprycel (dasatinib)
- Sutent (sunitinib maleate)
- Tarceva (erlotinib)
- Vectibix (panitumumab)
- Velcade (bortezomib)
TABLE OF CONTENTS
- 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 Benefi t 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
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