Covance: Addressing Operational Challenges in Conducting Clinical Trials [Infographic]
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Challenge to Patient Enrollment Site Selection Facts Challenge to On-Time Completion Financial Impact of Trial Delays Addressing Operational Challenges in Conducting Clinical Trials Critical task of site selection is often carried out in a non-scientific and non-systematic way 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. Decrease Trial Delays with Xcellerate - Clinical Trial Optimization Oncology Case Study Covance has the most comprehensive clinical trial knowledge base in the industry with more than 7,000 protocols including 132k unique investigators experienced in conducting clinical trials Inputs Insight & Analysis Insight & Analysis Applications Process Xcellerate ® Public - Macro Non-Public - Macro 1572s Feasibility & Site Selection Clinical Execution Strategy Study Performance & Management Resource Management Financial Management Clinical Supply Chain Subscription Data Clintrials. Gov Covance Experience CTMS Site Surveys 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 - 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. Patient enrollment challenge is the leading cause of missed clinical trial deadlines 0 10 20 30 40 50 Phase I Phase II Phase III 42% 31% 30% Average Clinical Trials Overrun Across All Therapeutic Areas* 0 10 20 30 40 50 60 Endo & Metabolic Oncology Infectious Diseases Respiratory Muscles & Skeletal Cardiovascular Mental & Behavioral Neurology Gastrointestinal Genital & Urinary Hematology Ophthalmology Dermatology 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 Non-performing sites by therapeutic area Schedule per trial in months Delay = 10.8 Delay = 10.8 Delay = 10.8 Delay = 10.8 Delay = 10.8 Mean Clinical Trials Schedule and Delay by Therapeutic Area (Phase I - Phase III) Loss of revenue for a blockbuster drug Loss of revenue for an average drug CenterWatch Study 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 50% decrease in trial delay decreases $1.296M in revenue loss for a blockbuster drug 10.8 months of delay = $194M 5.4 months of delay = $97M 50% decrease in trial delay reduces $97M in revenue loss for an average drug Scenario of one clinical trial, delayed for 10.8 months Non-perfoming sites reduced to 36% 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 regula- tory 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 1 Year Ahead of Schedule Delay = 10.8 Delay = 10.8 Delay = 10.8 Delay = 10.8 CNS All Cardiovascular Anti-infective Anesthetic 92.5 72.1 61 50.5 46.4 Delay = 10.8 41% 60% 49% 51% 35% 45% 28% 35% 52% 30% 57% 43% 37% ** *** ****
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Challenge to Patient Enrollment
Site Selection Facts
Challenge to On-Time Completion
Financial Impact of Trial Delays
Addressing Operational Challenges in Conducting Clinical Trials
Critical task of site selection is often carried out in a non-scientific and non-systematic way
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 30trials on average, for each company.
Decrease Trial Delays withXcellerate - Clinical Trial Optimization
Oncology Case Study
Covance has the most comprehensive clinical trial knowledge base in the industry with more than7,000 protocols including 132k 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
Close to
80% of clinical trials fail to meet milestonesThe process of translating lab research into potentially life-saving treatments is often severely delayed
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 andthen end up enrolling one patient.
Patient enrollment challenge is the leading cause of missed clinical trial deadlines
0
10
20
30
40
50
Phase I
Phase II
Phase III
42% 31% 30%Average Clinical Trials OverrunAcross All Therapeutic Areas*
0
10
20
30
40
50
60
End
o &
Met
abol
ic
Onc
olog
y
Infe
ctio
us D
isea
ses
Res
pira
tory
Mus
cles
& S
kele
tal
Car
diov
ascu
lar
Men
tal &
Beh
avio
ral
Neu
rolo
gy
Gas
troi
ntes
tinal
Gen
ital &
Urin
ary
Hem
atol
ogy
Oph
thal
mol
ogy
Der
mat
olog
y
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
Non-performing sites by therapeutic area
Schedule per trial in months
Delay = 10.8 Delay = 10.8 Delay = 10.8 Delay = 10.8
CNS All Cardiovascular Anti-infective Anesthetic
46.4 50.5 61 72.1 92.5Delay = 10.8
Mean Clinical Trials Schedule and Delay by Therapeutic Area (Phase I - Phase III)
Loss of revenue for a blockbuster drug
Loss of revenue for an average drug
CenterWatch Study
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
50% decrease in trial delay decreases $1.296M in revenue loss for a blockbuster drug
10.8 months of delay = $194M
5.4 months of delay = $97M
50% decrease in trial delay reduces $97M in revenue loss for an average drug
Scenario of one clinical trial, delayed for 10.8 months
Non-perfoming sitesreduced to
36%
A case study demonstrated that Xcelleratehelped 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 regula-tory 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
1 YearAhead ofSchedule
Delay = 10.8 Delay = 10.8 Delay = 10.8 Delay = 10.8
CNS All Cardiovascular Anti-infective Anesthetic
92.5 72.1 61 50.5 46.4Delay = 10.8
41% 60% 49% 51% 35% 45% 28% 35% 52% 30% 57% 43% 37%
**
***
****
