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.

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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)

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