Transcript INTRODUCTION

EDC: THE EXPERIENCE OF A CRO
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INTRODUCTION
• Expenditure on research and development by
pharmaceutical industry is increasing worldwide and
is currently estimated to be over $45 billion a year
• Despite the rise in R&D spending, there has not been
a corresponding growth in the number of innovative
drugs generated through such investment
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INTRODUCTION
One key bottleneck of turning biomedical
innovations into actual product has been the design
and execution of critical clinical trials to prove the
safety and efficacy of various innovative biomedical
products while balancing regulatory pressures with a
constant drive to control costs and improve quality
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INTRODUCTION
It is widely believed that the adoption and use of
information technology is critical in helping
companies to satisfy these demands within the
clinical operating environment
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INTRODUCTION
However, although technology dominates almost
every aspect of our lives, from moving money safely,
securely and predictably around the world without
pen or signature to purchasing anything imaginable
over the Internet………
in data collection from clinical trials
“paper” is still king
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INTRODUCTION
Among the different technological solutions to be
used in clinical trials, the “internet approach”
offers the advantages of the combination of the
desired targets in R&D:
a) high quality
b) shorter time
c) lower costs
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WHY THE INTERNET?
• Growing popularity/accessibility
• Many uses
- business
- personal
- very low users barrier
• Still a number of concerns but progressively solved
- privacy/security
- data integrity
- bandwith
• Integrating with other technologies
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INTERNET APPLICATIONS FOR TODAY’S
CLINICAL TRIAL
• Ethics submissions
• Patient recruitment
• Monitoring
• Patient education and communication
• Professional education (e-learning)
• Virtual Investigators’ meeting (video streaming)
• Electronic data capture
• Data Management
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THE E-CLINICAL TECHNOLOGY
MARKET
Total spending in 2004 for external ECT solutions –
hardware, software applications and implementation
services – was an estimated $200 million.
Presently, 15% of all newly initiated clinical trials are
using e-clinical technologies suggesting a total
potential ECT market of $1 billion to $1.3 billion if
sponsors elect to use external vendor solutions
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THE E-CLINICAL TECHNOLOGY
MARKET
The market is growing by 23% annually. Experts
expect market growth to accellerate modestly due to the
following key factors:
 FDA support for CDISC’s data submission
standards has added credibility
 Investment capital continues to flow into the
eClinical market at a significant level
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THE E-CLINICAL TECHNOLOGY
MARKET
 The market continues to consolidate as smaller
players exit or are acquired
 Growing numbers of biopharmaceutical companies
have been publicly reporting speed, quality and cost
advantages in support of eCT solutions
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THE E-CLINICAL TECHNOLOGY
MARKET
 According to recent surveys, vendor solutions are
offering improved functionality and performance
 Technology provisioning costs are dropping as
adoption increases
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WHAT INFORMATION EXISTS PROVING
THE VALUE PROPOSITION OF EDC?
The definition of value can be defined in:
- direct economic (defined as pure cost-savings)
- indirect economic (defined as opportunistic benefits
such as the chance to increase revenue resulting from
enhanced productivity)
- societal implications (defined in this market as getting
valuable drugs to market faster or preventing harmful
drugs from being unduly exposed to patients)
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WHAT INFORMATION EXISTS PROVING
THE VALUE PROPOSITION OF EDC?
The three most important criteria to improve in any
product development effort are:
Quality
Time
Cost
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WHAT INFORMATION EXISTS PROVING
THE VALUE PROPOSITION OF EDC?
In market of drug and device development these factors
are likely in the correct order and given the fact that
approved products eventually sell for hundreds of
million dollars annually, each of these factors have
significant economic implications
These three “metrics” have all been shown to be
significantly impacted through the proper use of EDC
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Comparison of metrics between EDC and paper
methods in two Phase II clinical trials with the
same drug and similarly sized projects
( by Banik, et al : Bayer Pharmaceuticals 1998)
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ITEMIZATION OF EFFICIENCIES AND ADVANTAGES OF
EDC OVER TRADITIONAL MANUAL METHODS
Tasks
Paper-based trial
Web-based trial (EDC)
Paper CRFs
Yes
No
Printing and shipping of
CRFs
Yes
No
Double-key by Sponsor
Entered once by site
Edit and logic checks
Using statistical software
At time of data entry
Query management
Paper forms
Electronic records
Data Management
Paper forms
Instantaneous audit trail
All done in field
In field and in office
(Reduction of 20-80%project dependent)
Problems identified
At site
In advance
Problems resolved
After site visit
Before site visit
Data entry
Monitoring
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EDC vs PAPER: COST COMPARISON
Indication
Cardiology
Atopy
Oncology
Crohn
disease
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# Pts
400
900
1000
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# Sites
Paper or
EDC?
Total Price
EURO
Difference
EDC/paper
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Paper
eDC
1.428.000,00
1.190.000,00
- 20%
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Paper
eDC
666.315,00
569.500,00
- 17%
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Paper
eDC
1.159.940,00
983.000,00
- 18 %
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Paper
eDC
248.000,00
240.000,00
- 1,6 %
EDC IN CLINICAL TRIALS :
International experience
AREAS OF COSTS SAVINGS
The following are estimated cost eliminations of a 40
center, multicenter study with 1,000 patients and a
100 pages Case Report Form (CRF):
Source: www.targethealth.com
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EDC IN CLINICAL TRIALS :
International experience
AREAS OF COSTS SAVINGS
• Printing of the CRF:
This cost can be as high as $100/book. For 1,000
patients, this represents a cost elimination of
$100,000 plus resources to ship and direct shipping
costs
Source: www.targethealth.com
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EDC IN CLINICAL TRIALS :
International experience
AREAS OF COSTS SAVINGS
• Double-Key Data Entry:
This cost can be as high as $3/pagex2. For a 100
page case book and 1,000 patients, this represents a
cost elimination of $600,000
Source: www.targethealth.com
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EDC IN CLINICAL TRIALS :
International experience
AREAS OF COSTS SAVINGS
• Query Management:
In a case study comparing a paper query management
system with an electronic online system using edit and
logic checks, there was a 65% reduction in queries. For
the current hypothetical study, there would be a reduction
from 3,000 paper queries to approximately 1,000. Using
an estimated in-house cost of query management of
$50/query, there would be a savings of approximately
$100,000
Source: www.targethealth.com
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EDC IN CLINICAL TRIALS :
International experience
AREAS OF COSTS SAVINGS
• Monitoring:
Since many monitoring problems can been identified in
advance, there can be a reduction of at least one monitoring
trip, as well as a reduction of time spent at the study site. Even
if just one trip and an additional one day of monitoring is
saved for each study site, for a multicenter study with 40 sites,
the savings for one day of travel, one day of monitoring and
travel costs could run up to $3,000/site.The total savings in
this case would be $120,000
Source: www.targethealth.com
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THE RISK OF EDC MISPERCEPTION
• The poor team workflow destroys the value
proposition of EDC contributing to the
misperception that “EDC is too expensive”
• In technology circles this is explained by the
equation of
New Technology + Old Process = Very Expensive Old Process
(NT)
(OP)
(VEOP)
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THE RISK OF EDC MISPERCEPTION
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INTERNET APPLICATIONS FOR
TOMORROW’S CLINICAL TRIAL
THE “eCLINICAL TRIAL”
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eCLINICAL TRIAL
A clinical trial in which primarily electronic
processes are used to collect (acquire), access,
exchange and archive data and documents required
for conduct, management, analysis and reporting of
the trial
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THE REAL BENEFITS OF AN
eCLINICAL TRIAL APPROACH
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THE REAL BENEFITS OF AN
eCLINICAL TRIAL APPROACH
Creating a more efficient and streamlined study
management process and removing “paper”
redundancies are indeed enormous measurable benefits
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THE REAL BENEFITS OF AN
eCLINICAL TRIAL APPROACH
But there are other intangible benefits of eClinical trial
that are not easily transparent and often difficult to
measure which can be the most advantageous to the
sponsor and CRO clinical study team
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THE REAL BENEFITS OF AN
eCLINICAL TRIAL APPROACH
•Dynamic site management
• Transparency
•Centralized study randomization
•Effective trial drug supply management
•Dynamic program management
•Better planning
•Less frequent site visits
•Shared documents file
•Continuous collaboration
•Real time safety evaluation
•Fast fail decisions
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DYNAMIC SITE MANAGEMENT
Problems with data quality captured at investigative
sites, whether due to ineffective site training, poorly
designed case report forms or inattentive site personnel,
can be identified and resolved quickly, eliminating
many errors downstream
In a paper trial, repetitive errors build up over time
because of the time lag between data entry and data
validation/review.
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DYNAMIC SITE MANAGEMENT
In eClinical processes, automatic queries provide
instantaneous corrective feedback to sites
Clinical monitors have a continuous window into site
data entry practices enabling them to intervene quickly
before a small issues becomes a major problem
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DYNAMIC SITE MANAGEMENT
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DYNAMIC SITE MANAGEMENT
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TRANSPARENCY
One of the most overlooked benefits to an eClinical
trial utilizing real time data capture and reporting is that
the sponsor for the first time has the ability to measure
their vendor’s (i.e. eCRO and participating sites)
performance online in real time
With information management tools, every site contact
report, monitoring visit, and patient enrollment metric
is available 24/7 from virtually anywhere in the world
through an Internet connection
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TRANSPARENCY
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CENTRALIZED STUDY
RANDOMIZATION
The e-randomization procedure will prevent the
incorrect enrollment, into the study, of patients not
fulfilling all the inclusion and exclusion criteria.
Therefore less patients are needed to reach the
calculated sample size required for the per-protocol
analysis
Ultimately this will ensure reduced timelines and costs
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CENTRALIZED STUDY
RANDOMIZATION
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EFFECTIVE TRIAL DRUG SUPPLY
MANAGEMENT
Assigning the randomization code and the appropriate
“Trial Drug Kit”, the system automatically update the
“Drug Distribution Process” and activate, if the case,
the order of new supplies to investigational sites
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EFFECTIVE TRIAL DRUG SUPPLY MANAGEMENT
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EFFECTIVE TRIAL DRUG SUPPLY
MANAGEMENT
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DYNAMIC PROJECT MANAGEMENT
Real time tracking of patient enrollment can help
control trial size
The continuous evaluation of screening results will
help to determine whether protocol modifications may
be required, such as inclusion/exclusion criteria
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DYNAMIC PROJECT MANAGEMENT
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BETTER PLANNING
Earlier acces to better information allows to take an
informed look at the next stages of the development
program
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LESS FREQUENT SITE VISITS
In an eClinical trial environment, monitors review data
inhouse between site visits. This ongoing review
facilitates interaction/communication with site
personnel and leads to dynamic site management
Because ongoing data review is being performed,
CRAs can visit sites less frequently saving on travel
expenses as well
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LESS FREQUENT SITE VISITS
When visits are scheduled, actual monitoring time is
used more efficiently and customized per site
Surprises at the eClinical sites are virtually eliminated,
and reducing CRA travel improves staff retention and
productivity
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LESS FREQUENT SITE VISITS
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SHARE DOCUMENTS FILE
eTrial Master File must be accessed by the CRO study
team as well as by the Sponsor and the Investigators.
Documents collection metrics (i.e. time to … or
number of documents available etc) must be used as
performance indicators for both CRAs and
Investigators
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SHARE DOCUMENTS FILE
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CONTINUOUS COLLABORATION
With eClinical trial, a study team is now unified by a
common information set and the entire clinical teamsponsor, CRO and sites- can base decisions on
accessible, real time, accurate information
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REAL TIME SAFETY EVALUATION
Because study data is received in real time, potential
safety issues can be evaluated and appropriate courses
of action determined quickly
This allows for improved patient safety while also
enabling quicker go-no go decisions based on safety
issues that may arise
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FAST FAIL DECISIONS
With better and faster efficacy and safety information is
possible to make more informed go-no go decisions
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CONCLUDING COMMENTS
As illustrated by the development of recruitment,
electronic data capture, monitoring, patient education,
project management, documents and data management
applications, the Internet is becoming an inportant
feature of today’s clinical trial paradigm
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CONCLUDING COMMENTS cont’d
For the Internet’s full potential of efficiency and quality
improvement to be realized, there is a need for:
- a more comprehensive appreciation of clinical
trial activities (i.e. the eClinical approach with
an integrated e-environment monitoring all the
study related processes)
- a commitment to data quality/regulatory
requirements
- universal attention to the development of
standards (ICH/CDISC/HL7)
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CONCLUDING COMMENTS cont’d
The CRO must understand the value and benefits of
the adoption of EDC technologies, and must be
prepared to enforce effective new workflow in order to
avoid the improper addition of tehcnology costs onto
paper instead of logically eliminating redundancy
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Thanks for your attention!
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