Creating a Roadmap to Clinical Trial Efficiency

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Creating a Roadmap toClinical Trial Efficiency
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Value Envisioned. Value Delivered.
Clinical Trial ManagementMaximizing Existing
Assets
Clinical trial management is becoming ever
more complex. In order to meet the challengesof
today and those of tomorrow, clinicaltrial
management processes must evolve.Fortunately,
evolution does not equate tovast new technology
systems. In fact, manycompanies already possess
the key piecesof technology required.
Improvements aresimply a matter of leveraging
those technologycapabilities more effectively.
Executive Summary
Managing a clinical trial of any size and
complexityrequires efficient trial management.
Yet for the
expected. Drug development teams are also
facedwith ensuring smart strategies for the
emerging
past three decades, life sciences companies
havebuilt and then continuously added to
inefficient
challenges, including mobile health,
socialmedia, electronic health record data,
genomicsinformation and the tsunami of big
data.In order to meet these challenges, life
sciencescompanies must improve the efficiency
ofinternal clinical management processes,
reducemanual reporting and human intervention,
andprovide better visibility across the clinical
triallandscape. Conducting a clinical
architectureassessment allows companies to get a
full pictureof see what current systems and
processes theyhave, understand what is working,
and moreimportantly critically identify the gaps
of what isnot working and what is missing. It
provides theteam with a path roadmap forward to
synchronizedimprovement in both improving their
systems andtheir operations, enabling effective
change in thenear and long term. When these two
facets ofsystems and operations are optimized
and in sync,the resulting improvements are
greater than thesum of optimizing each
individually.
processes, often cobbling together critical
systemsupport functions. At the same time, the
businessenvironment and regulatory factors have
made
the clinical trial landscape progressively
morecomplex. A focus on outsourcing
partnerships,in addition to a significant number
of mergersand acquisitions over the last 10
years, has
added to this complexity. In 2011 alone,
despiteuncertainties on both economic and
regulatoryfronts, over 200 billion in
healthcare related MAdeals were announced.1
Simultaneously, health authorities are
demandingbetter, faster disclosure of data. In
September
2012, the U.S. Secretary of Health and
HumanServices delegated its clinical trial
monitoring
authority to the U.S. Food and Drug
Administration(FDA). Though the full
implications of this changeare not yet known,
increased GCP inspections
and more stringent compliance requirements are
1 Healthcare and Life Sciences Group, Mergersand
Acquisitions, 2011 Year in Review, Sullivan
Cromwell LLP,
http/www.sullcrom com/files/upload/Healthcare
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Introduction
7.5
Developing a drug, biologic, or device is a
costlyundertaking. On average, the drug
developmentprocess takes more than 10 years and
1 billiondollars.2 About 85 percent of
therapies fail in earlyclinical trials, and of
those that survive through tothe last step
before regulatory approval, only halfare
approved.3 (see figure 1)
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85
85 of All Drugs Fail
But success is not solely dependent on the
qualityof the investigational product. Experts
suggest asignificant number of high viability
products arebeing lost to outdated and
impractical clinical trialdesigns and the lack
of a streamlined, integratedapproach to trial
management.
During the Development Stage15 Survive
Development
7.5 Make it to Approval
Figure 1
The high numbers of mergers and acquisitionsthat
have taken place in the industry have playeda
significant role in creating dysfunctional
trialmanagement processes. Clinical trials,
under
The evolving and multifaceted landscape
ofcompliance requirements adds additional
strain. Forone example, global health
authorities such as theFDA now require companies
to submit public dataabout ongoing and past
clinical trials. However, a2012 analysis of the
FDA data set on clinical trialsfound that much
of that data is missing. In fact,only 22 percent
of completed trials reported resultswithin a
year, as required.4
any circumstances, involve a tangle of
playersand systems. But as MAs occur, the
companiesinvolved often inherit a mix of
disparate technologyand clinical trial business
processes in addition totheir own. Rather than
use the changing businessenvironment as an
opportunity to holistically reviewand integrate
such processes and systems, manycompanies manage
the new jumble of disjointedprocesses and
systems as best they can.Meanwhile, a number of
external pressureschallenge the feasibility of
clinical trial businessas usual. The economic
landscape has changeddramatically in the last 10
years. Life sciencescompanies no longer generate
the high levels ofrevenue they commanded in the
early 2000s. Notonly are they faced with
increasing throughput tostay solvent, in many
cases they have been forcedto reduce headcount
as well.
Given the increasingly challenging business
andregulatory environment, life sciences
companiesmust evolve their clinical trials
processes andimprove efficiency with fewer
resources.
2 Translational Research 4 ways to fix the
clinical trial, Nature.com, September
2011,http//www.nature.com/news/2011/110928full/4
77526a html
3 Translational Research 4 ways to fix the
clinical trial, Nature.com, September
2011,http//www.nature.com/news/2011/110928full/4
77526a.html
4 Compliance with mandatory reporting of clinical
trial results on ClinicalTrials.gov cross
sectional study, BMJ Group, January2012,
http//www.bmj.com/content/344/bmjd7373
pdf2Bhtml
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Value Envisioned. Value Delivered.
Clinical Architecture
Develop Clinical Strategy
Investigator Portal
Adverse Event
Capture Adverse Event
Reporting System
Register Clinical Studies
SPL and PIM
Project
Management System
Adverse Event Data Entry and Coding
Submit and Negotiate
Indentify, Assessand Select CROs
IND
Clinical Trialand Results
Study, Planning and Design
Medical Evaluation Safety System
Registration System
Labeling
Grants
Develop Labeling Management
Study Initiation/ Startup
Periodic Regulatory Reporting
System
Management System
Patient
Recruitmentand Enrollment
Safety Data
Clinical DataManagement
Expedited Adverse
Manage Labeling
Event Reporting Warehouse
Study Monitoring and Conduct
StatisticalAnalysis Tool
Clinical Trial Disclosure
Signal Detection
Study
Management
Submit Labeling
Study DataCollection andManagement
Develop Risk MeDRAEvaluation and
Clinical TrialManagement
Strategy
System
Submit and Negotiate
Study Outputand Closeout
Adverse Event
NDA
Submissions DocumentManagement
Investigator Database
Reconciliation Safety Data
Study Reporting and Analysis
ReconciliationTrending Tools
Disclose Study Results
Risk Identificationand Management
Envisioning a Better Model
Clinical trials are not only complex to
accomplish,there is also a large variance
between trials. Asa result, business processes
and systems are
Portals, Interactive Voice Response Systems,
andelectronic Patient Reported Outcomes
systemsexist and must integrate into the larger
clinical
challenged to support and scale, and
technologysolutions are often introduced as a
point-in-
architecture and capabilities.
This onslaught of systems presents challenges
ontwo fronts information does not flow
appropriatelybetween systems and business
processes, andthe company often operates using a
patchwork of
time fix, which results in additional
complexityor redundancy. Often, a lack of
understandingof interfaces between application
portfolios andfunctional areas exists, and
systems are not
systems and process functionalities. Managing
thisscenario on a day-to-day basis can equate to
whata computer programmer might deem a hack
ontop of a hack. The approach may provide the
datathe company needs to get through the day,
but it
strategically integrated. Ultimately, knowledge
isnot consolidated, easy to access, or reusable.
The technology landscape of a typical life
sciencescompany includes a large variety of
system
capabilities and vendors, which continue to
pushthe feature sets they support for a given
user roleor business process. In clinical
systems
provides little assurance as to the quality of
the dataor the long term reliability of the
systems throughoutthe clinical development
program.
alone, where once there was just Clinical
TrialManagement Systems (CTMS), Clinical Data
For example, a company without a solid graspon
their master data management architecturemay
have different users entering critical trial
Management Systems, and electronic Data
Capture,today a host of capabilities such as
electronic TrialMaster Files, external
collaboration/Investigator
management data points in conflict in two or more
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levels of visibility and for obtaining data
aboutclinical trials on an interim basis
throughout thestudy rather than only at the
studys conclusion.The FDA is also beginning to
emphasize system
Companies need to anticipatethe impact of
industry changesand enable transformation
to a more agile, integratedenterprise while
strategicallyeliminating unnecessary
level inspections rather than trial level
inspections.An FDA inspection of a companys
monitoring
process for a program with several trials
couldpotentially expose a broad range of process
anddata inconsistencies.
or redundant systems andreducing operating
expenses.
Today, life sciences companies no longer have
thefinancial or personnel resources required to
makesystems and processes work using brute force
systems. Not only is this duplicative and
errorprone, but it creates a situation where
authoritativedata is not available for decision
making and reuse.Such processes are often
conducted by lower levelemployees who are
completing their work to thebest of their
abilities, and who may not understandthe
downstream implications. At the same
time,tactical technology solutions make
understandingapplication portfolios and
interfaces difficult.Companies often build-out
ancillary capabilitiesin their tools, which can
lead to systems withoverlapping but disconnected
feature functions.This means it is often
difficult to stitch everythingback together to
obtain a global or product levelview across a
study. For instance, a manager cannoteasily
ascertain project status and so
devotessignificant non-value added time to
answer questionsfor senior management.
Just-in-time data is noteasily mined to
identify risk signals that requirereview,
analysis and potential corrective actions.Not
only does this complexity present
challengeswithin the company, but as clinical
trials havebecome more collaborative over the
last severalyears, involving two or more
companies inoutsourcing or co-development
relationships,proprietary ad-hoc processes and
datainefficiencies become joint sources of
complexityand risk.
alone. Instead, fundamental changes to
clinicaltrial systems are needed. Business
processesand systems must evolve to support,
scale,
and improve efficiencies. Companies need
toanticipate the impact of industry changes and
enable transformation to a more agile,
integratedenterprise while strategically
eliminating
unnecessary or redundant systems and
reducingoperating expenses.
Building the New TrialManagement Architecture
Fortunately, a more efficient, manageable,
andmaintainable trial management process
is possible. But simply adopting newclinical
management technologies and forcingbusiness
processes to conform to the systemscapabilities
will not achieve the goal. Instead, thecompany
needs to first understand the flow ofactivities
and data across the business processes,and be
willing to rethink the process stepsnecessary to
remain compliant with GCPand local regulations.
Effectively assessing and depicting the
currentstate of the clinical architecture
environment,defined as the ecosystem of system
features,capabilities, and data that support the
overallClinical Trial Management business
processes,
As the FDA takes over drug trial
monitoringresponsibilities from the U.S.
Department of Healthand Human Services, they are
pushing for higher
is an ideal starting point. First, model the
current
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Value Envisioned. Value Delivered.
state by defining the business capabilities
neededto conduct a clinical trial. These include
activitiessuch as site monitoring, project
management,
Conclusion
Without thorough insight into current
processesand technologies, a company cannot
effectivelychange the current state or be
prepared for
supplies management, content management,and site
interactions, for example. Some activitiesare
functional and will stretch across
multipleprocesses, while others are specific to
a givenprocess. For example, clinical trial
processesresult in regulated content that
requires control, socontent management is a core
process that wouldbe mapped to multiple business
processes.Once business processes are
identified, examinehow data moves through the
process. Whichbusiness processes are most
manually intensive?Where do hand-offs occur
between roles?Finally, define the user
communities and theinformation they require to
support businessprocesses. Define the data
users need, whichsystems and business processes
they must interactwith, and determine the most
efficient and costeffective way to provide that
data.
a dynamic future state. A clinical
architectureassessment delivers insight into
applications andtheir interface with
business/operations processes.It s and provides
a dynamic, graphical view intothe current
portfolio of systems and delivers .Additionally,
it provides visibility into potentialbottlenecks,
demonstrating how data movesthrough a diverse
application portfolio, and showshow proposed
changes to the flow affect all areasof clinical
architecture. Finally, a roadmap providesa
manageable, structured path to improvementthat
is feasible in the current environment,
enablingtransformation to a more agile,
integrated, andcompliant enterprise and allows
for the strategicelimination of unnecessary or
redundant systems tosignificantly reduce
operating expenses. In additionconcert with IT
improvements, the to improvingthe IT side of the
equation, following the roadmaphelps ensure that
the business/operations teamis operating within
a framework that puts themin a position to
succeedbeing more efficientand delivering
results today, and prepared for thechanges to
come in the clinical trials of tomorrow.
Next, map findings back to current scenarios
anddetermine priorities. What are the most
critical
capabilities? If content management affects
60of the processes and is also manually
intensive,for example, it is assigned a high
impact score.Evaluating what the business can
handle from a
change standpoint is also taken into
consideration.Determine which parts of the
business are mostopen to transformation and tie
that into the
prioritization. In other words, just because
contentmanagement is high on the capability
priority list
does not automatically mean it is the right
choice forthe business today. All project
dependencies mustbe considered before
prioritization is complete.
As dots are connected, a roadmap begins
toappear, and the processes emerge that need
tobe examined and re-engineered most
urgently.From here, the company can take action
on animplementable, practical capability
roadmap.
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About Paragon Solutions
Paragon Solutions is an advisory consulting
and systems integration firm that specializes in
enterprise information management to help
clientsleverage information assets for better
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specializedtechnology competencies that help
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Paragon works with businesses that are focusedin
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work with Paragons competency groups to
addresstodays client concerns in Process
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