Challenge to Patient Enrollment

Challenge to On-Time Completion

Financial Impact of Trial Delays

ADDRESSING OPERATIONAL CHALLENGES IN CONDUCTING CLINICAL TRIALS

Decrease Trial Delays withXcellerate® - Clinical Trial Optimization®

Oncology Case Study

Covance has the most comprehensive clinical trial knowledge base in the industry with more than11,000 protocols including 175,000+ unique investigators experienced in conducting clinical trials.

Inputs

Insight & Analysis

Insight & Analysis

ApplicationsProcess

Xcellerate®

Public - Macro

Non-Public - Macro

1572s

Feasibility & SiteSelection

Clinical ExecutionStrategy

Study Performance& Management

Resource Management

FinancialManagement

Clinical SupplyChain

Subscription Data

Clintrials.gov

Covance Experience

CTMS

Site Surveys

Schedule per trial in months

Mean Clinical Trials Schedule and Delay by Therapeutic Area (Phase I - Phase III)

Loss of revenue for a blockbuster drug

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***...

To effectively decrease the clinical trial delay, one of the best ways is to reduce the number of non-performing or low-performing sites.

10.8 months of delay = $2.592M

5.4 months of delay = $1.296M

10.8 months of delay = $194M

5.4 months of delay = $97M

Scenario of one clinical trial, delayed for 10.8 months

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%.

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.

Highlight

* 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

***

****

INFCDS001-0714

Close to

80% of clinical trials fail to meet milestones

The process of translating lab research into potentially life-saving treatments is often severely delayed.

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 timelineSites never enroll a single patient or sites do nothing for a long period of time and then end up enrolling one patient.

PH

AS

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PH

AS

E I

I

PH

AS

E I

II

42% 31% 30%

Average Clinical Trials Overrun Across All Therapeutic Areas* Site Selection Facts

Non-performing sites by therapeutic area

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41% 60% 49% 51% 35% 45% 28% 35% 52% 30% 57% 43% 37%**

Critical task of site selection is often carried out in a non-scientific and non-systematic way.

• Results in selection of non-performing sites

• Non-performing sites cause wasted operational efforts and study delay

• Non-performing sites widely exist throughout different therapeutic areas

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.

CNS ALL Cardiovascular Anti-infective Anesthetic

92.5 72.1 61 50.5 46.4DELAY = 10.8 DELAY = 10.8 DELAY = 10.8 DELAY = 10.8 DELAY = 10.8

CenterWatch Study

50% decrease in trial delay decreases $1.296M in revenue loss for a blockbuster drug

50% decrease in trial delay reduces $97M in revenue loss for an average drug

Loss of revenue for an average drug

36%

Non-performing sites reduced to

1 Year Ahead of Schedule

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