the digital clinical trial: placing the right bets
TRANSCRIPT
PLACING THETHE DIGITAL CLINICAL TRIAL:
RIGHT BETS
TODAY'S INDUSTRY CHALLENGES REQUIRE FOCUS ON INNOVATION AND PATIENT OUTCOMES
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Expanding trial durationTreatment periods increased by
25%since 20002
Decreased success rateEven with tremendously higher investments, clinical trial success rates stagnated in the last decade
Increasing CostsParticipant eligibility criteria and trials procedures increased by
58%Case report form pages by 227% since 20002
STUDY CLOSEOUT
Real-word evidence in design of protocols and modeling expected outcomesAdaptive trial designPatient articulated outcomes in product and program design
DIGITAL TECHNOLOGIES CAN IMPROVE CLINICAL DEVELOPMENT AND ENHANCE THE R&D VALUE CHAIN
Predictive analysis and risk identification; improved protocol design
Social platform for patient recruitment and ongoing trial awarenessSite and patient identification using analytics
Faster site patient identification and enrollment
Digital tools for screening, consent and cohort randomizationOptimized site start-up leveraging digital platforms
Faster site start-up; increased patient understanding & compliance
Electronic supply chain management eLabels for optimized drug authorization, shipment and reconciliation
Transparent, effcient, and cost effective delivery
eSourced collection and cloud-based data aggregationWearable direct data captureNear real-time accessOngoing data interim analysisPatient compliance & adherence digital toolsReal world/EMR data as a placebo arm
Real time data access, monitoring, control; improved patient experience
Early detection of data trends; decreased early withdrawals
Real time data access, monitoring, control; improved patient experience
Automated data analysisAutomated generation of TLF&Gs (Tables, Listings, Figures and Graphs)
Faster and more transparent access to data
Electronic submission and filing for regulatory review
Improved speed to market
Digital tools to thank patients and provide results/data
Increased patient understanding and compassio-nate care
STUDY DESIGN/PRE-STUDY
STUDY START-UP STUDY CONDUCT
Dig
ital m
etho
dsVa
lue
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Real world evidence, adaptive trial design, and inclusion of patient perspectives to enhance clinical trial design
DIGITAL CAPABILITIES ARE CREATING SPONSOR AND PATIENT VALUE
TRIAL DESIGN
Analytics and digital learning platforms for site selection and engagement
TRIAL START-UP
Digital tools to enhance patient recruitment and trial adherence while speeding time to database close
TRIAL CONDUCT & CLOSEOUT
1 2 3
TRIAL DESIGN
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Real world evidence, adaptive trial design, and inclusion of patient perspectives to enhance clinical trial design
• One- dimensional trial design• Rigid trial protocols• Significant patient burden
CURRENT CHALLENGES
• RWE and RWD to leverage previous trial success and failure
• Adaptive trial design and digital simulation of trial scenarios
• Patient and caregiver involvement via digital platforms
DIGITAL ENABLER
• Decrease protocol complexity• Increase ability to predict
protocol outcomes• Reduce trial delays and non-
value added activities• Improve patient experience
and outcomes
KEY OUTCOMES
1
TRIAL START-UP
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2 Analytics and digital learning platforms for site selection and engagement
• Ineffective site selection• High site related costs ⎯ Recruitment, retention and
monitoring account for ~30% of trial costs3
• Low patient recruiting rate⎯ ~50% of all trials fail to
achieve planned patient enrollment targets4
• Site identification using analytics and aggregated databases
• Electronic health records (EHR) to model patient populations and inform about an investigator’s ability to recruit
• Automation of process through Artificial Intelligence (AI) for site selection
• Digital media for training and communication
• Improve site experience• Enhance ability to focus on the
high recruiting sites• Reduce cost (up to 10%3) with
remote management and training of sites
• Improve site engagement with digital training for staff
CURRENT CHALLENGES ACTION KEY OUTCOMES
TRIAL CONDUCT AND CLOSEOUT
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Digital tools to enhance patient recruitment and trial adherence while speeding time to database close
• Significant (~ 200%) delays in recruiting timelines3
• Clinical staff engagement critical, not under control of sponsor
• Significant patient drop out rate• Lack of patient adherence
• Automated and digital tools for patient screening and engagement
• Adherence control by remote digital systems
• Direct data capture via wearables and mobile networks
• Improve patient experiences• Reduce timelines from first
patient first visit to last patient first visit
• Enable precise data collection and real-time analysis
• Decrease time from data collection to data clean/ database close
3
ACTION KEY OUTCOMESCURRENT CHALLENGES
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RETHINKING CLINICAL TRIAL CONDUCT AND A MINDSET SHIFT WILL DRIVE DIGITALIZATION BENEFITSTo fully embrace digital and help enable end-to-end transformation, companies need to scale these capabilities to the enterprise level
Determine the needs of all clinical trial stakeholders (e.g., sponsors, sites, patients) to inform a digital clinical trial strategy
Define and implement a digital clinical trial strategy and plan aligned to a broader R&D digital strategy
Evaluate and incorporate the ongoing and planned digital pilots into the digital clinical trial strategy
Confirm top-level management alignment to set and communicate the digital clinical agenda, structure and culture within the development organization
Embed and test selected digital capabilities; document success / failures to continue scaling the right tools at the right time to new products or therapeutic areas
Next steps for realizing value through adoption of digital capabilities:
SPONSORS NEED NOT—AND SHOULD NOT—WAIT FOR ‘PERFECT’ DIGITAL TOOLS OR SOLUTIONS
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Sponsors will be able to reimagine how they conduct the critical activities of product development, which would measurably improve patient experiences and outcomes
By looking at patients and diseases holistically and interacting with patients differently, the digitalization of clinical trials would help:• Feed insights back into research and early development to improve disease
targeting and protect future patients a burdensome trial or therapy experience• Find the patients that benefit the most from a selected therapy and enroll
in high performing sites• Reduce the risk for all stakeholders by identifying issues in real-time, or better
yet, predicting them before they occur
Sponsors who “get in the game” and begin to place their digitalization bets will find themselves in the best position to be leaders in the future of clinical trials.
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FOR MORE INFORMATION PLEASE CONTACT:
Nicole Faust Cohen Managing Director Accelerated R&D Services—[email protected]
AUTHORS: CONTRIBUTOR:
Michael Heinke Manager—Accenture Business Strategy [email protected]
Ian C. Shafer Managing Director Accelerated R&D Services—Clinical Development [email protected]
Petra Jantzer Managing Director Accelerated R&D Services—Europe [email protected]
Katie M. Strasser Sr. Manager Accelerated R&D Services—[email protected]
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