ADDRESSING OPERATIONAL
CHALLENGES IN CONDUCTING
CLINICAL TRIALS
Challenge to Patient Enrollment
The process of translating lab research into
potentially life-saving treatments is often
severely delayed.
Close
to
80%
of clinical trials fail to meet milestones
Patient enrollment
challenge is the leading
cause of missed clinical
trial deadlines.
Patient Enrollment
Site Selection • Site Activation • Patient Recruitment
Selection of low or non-performing sites directly
impacts the study timeline
Sites never enroll a single patient or sites do nothing for a long period of time and then end up
enrolling one patient.
Average Clinical Trials
Overrun Across All
Therapeutic Areas*
Site Selection Facts
• Results in selection of non-performing sites
PHASE III
• Non-performing sites cause wasted operational efforts
and study delay
Dermatology
Ophthalmology
Hematology
Genital & Urinary
Gastrointestinal
Neurology
Mental & Behavioral
Cardiovascular
Respiratory
Oncology
Endo & Metabolic
42% 31% 30%
Muscles & Skeletal
• Non-performing sites widely exist throughout
different therapeutic areas
Infectious Diseases
PHASE I
PHASE II
Critical task of site selection is often carried out in a nonscientific and non-systematic way.
41% 60% 49% 51% 35% 45% 28% 35% 52% 30% 57% 43% 37%
**
Non-performing sites by therapeutic area
Challenge to On-Time Completion
The delays in patient recruitment due to non-performing sites for clinical trials account for an
average of 10.8 months lost per trial. When calculated, this is an annual cumulative loss of 26
years, with 30 trials on average, for each company.
Mean Clinical Trials Schedule and Delay by Therapeutic Area (Phase I - Phase III)
Schedule per trial in months
CNS
ALL
Cardiovascular
Anti-infective
Anesthetic
92.5
72.1
61
50.5
46.4
DELAY = 10.8
DELAY = 10.8
DELAY = 10.8
DELAY = 10.8
DELAY = 10.8
***
Financial Impact of Trial Delays
One major result of escalating clinical trial delays is the significant dollar impact on
study sponsors. In addition to higher study-related costs, sponsors can potentially
experience sales losses from $600,000 to $8 million per day due to trial delays***...
CenterWatch Study
To effectively decrease the clinical trial delay, one of the best ways is to reduce the number of
non-performing or low-performing sites.
Scenario of one clinical trial, delayed for 10.8 months
Loss of revenue for a blockbuster drug
10.8 months of delay = $2.592M
50% decrease in trial delay
decreases $1.296M in revenue
loss for a blockbuster drug
5.4 months of delay = $1.296M
Loss of revenue for an average drug
10.8 months of delay = $194M
50% decrease in trial delay
reduces $97M in revenue loss
for an average drug
5.4 months of delay = $97M
****
Decrease Trial Delays with
Xcellerate® - Clinical Trial Optimization®
Covance has the most comprehensive clinical trial knowledge base in the industry with more than
11,000 protocols including 175,000+ unique investigators experienced in conducting clinical trials.
Inputs
Process
Applications
Public - Macro
Feasibility & Site
Selection
1572s
Clinical Execution
Strategy
Subscription Data
Insight
& Analysis
Clintrials.gov
®
Xcellerate
Insight
& Analysis
Non-Public - Macro
Study Performance
& Management
Resource
Management
Covance Experience
Financial
Management
CTMS
Clinical Supply
Chain
Site Surveys
Oncology Case Study
A case study demonstrated that Xcellerate® helped deliver a pivotal study with a new
oncology compound more than one year ahead of schedule, by reducing the number
of low- and non-performing sites to 36%.
Non-performing
sites reduced to
36%
Highlight
A pivotal study of a new oncology compound faced the
challenge of managing site activation with rapid
enrollment. Forecasting the number and location of new
patients to be enrolled using Xcellerate® minimized the
number of non-performing sites. Low- and non-performing
sites were reduced to 36%, with patient recruitment
completed 9 months ahead of expectation, and regulatory
filing more than one year ahead of original schedule.
1 Year Ahead of Schedule
*
**
***
****
Cutting Edge Information, “Clinical Operations Benchmarking Per-Patient Costs, Staffing and Adaptive Design”, 2011
Covance Xcellerate® knowledgebase CLabs and Clinical Data, 2006-2010
R&D Costs and Returns by Therapeutic Category. Drug Information Journal, Vol. 38, pp 211-223
Datasource: PharmaCircle 2011 Global Drug Sales, CenterWatch Study 2011
Covance Inc., headquartered in Princeton, NJ, is the drug development business of
Laboratory Corporation of America® Holdings (LabCorp®). Covance is the marketing
name for Covance Inc. and its subsidiaries around the world.
© Copyright 2015 Covance Inc.
INFCDS001-0714