Unlike other therapeutic trials, oncology trials are more sensitive in nature and require specific clinical expertise to properly manage. Many participants are required to have already undergone front and even second lines of therapy and only if these have failed are they eligible for the experimental and toxic drugs often required in oncology trials. Costs are high, enrollment can be challenging and you are often working with medically-fragile patients. However, when managed properly, effective oncology trials can save lives, generate new revenue streams and make breakthrough discoveries in a challenging therapeutic area.

1. Click to edit Master title style
Click to edit Master title styleThe High Stakes of Running a
Successful Oncology Trial
David Hinds, MBA
Global Project Director
CLINIPACE WORLDWIDE

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www.clinipace.comRIGHT-SIZEDTM CLINICAL RESEARCH SERVICES
Technology-Amplified CRO
With our technology-amplified delivery model, sponsors have visibility to make
critical decisions around enrollment, site management, data collection,
investigator payments, milestone tracking and more.
Project Management
Site Selection and Global Study Feasibility
Clinical Monitoring and Site Management
Data Management
Biostatistics
Medical Management/Monitoring
Patient Recruitment
Regulatory Services
Medical Writing
Drug/Device Safety
Frictionless Services

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The Stakes are High…

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…And Getting Higher

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Industry is Responding…
652
358
345
326
296
223
155
131
100
99
98
97
94
77
72 50
31
2009 trial starts by therapeutic area
Cancer
Infectious Diseases
Miscellaneous
Central Nervous System
Hormonal Systems
Cardiovascular
Musculoskeletal
Respiratory
Gastrointestinal
Genitourinary
Dermatology
Hematological
Immune System
Pain
Eye and Ear
HIV Infections
Nephrology
Source: clinicaltrial.gov

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… But the Challenges are Great
Source: Pharmaceutical Research and Manufacturers of America, Pharmaceutical Industry Profile 2008 (Washington, DC: PhRMA, March 2008).
RegulatoryAnalysisOperationsDesign

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We already know
Source: CenterWatch 2003, 2005 survey of sites in U.S.
Getting it right at start-up can make all the difference

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Eligibility Criteria
Begins with therapeutic understanding
Seek input from treating clinicians
Evaluate trials in process
Remain current with literature review
Focus on the primary endpoint
Not too stringent
Not too relaxed
Consider the need for prior tissue samples

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Placebo-Controlled Trials
Traditionally best study design for regulatory
Conventional approach
Less opportunity for analysis bias
Seek to enable placebo-control while building rationale for
alternate design
Evaluate target sites and countries
Access to the appropriate patients
Effects on timeline on budget
Regulatory perspectives on Placebo-Control

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The Best Team
Trial
Success
Right Patients
Right
Structure
Right Staff
Right
Relationships
Right Sites
(location)

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Engaging Experts
Adaptive Trial design experts
Regulatory
Biostatistics
Operations
Work with your Agency(s)
Get to know your review division
Work with FDA to determine efficacy
and safety criteria
Seek guidance early and often
Find the right CRO to meet your
needs
 Objectives are not clear
Outcomes not well-defined or
analyzed
 Sample size not properly
documented
 Missing patients without
explanation
 Un-blinded analytic changes
without explanation
 SAEs that are dismissed
without description as
“inter-current illness”
 Sloppiness
FDA Red Flags

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Embracing Technology
Own, Use and Understand your Data
Start-up
Screening / Recruitment
Treatment
Operations
Analysis
Organize to leverage
technology
Adjust your trial as needed
in real-time
Avoid common operations
nightmares

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Q&A
David Hinds, MBA
Global Project Director
dhinds@clinipace.com