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TRANSCRIPT
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Public
Electronic Consent:Obtaining & Documenting Informed
Consent When the Patient is Not in the Room
Melanie Morris Associate Director,
Decentralized Clinical Trials
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Industry Shifts & The Evolution of Data
Defining eConsent and Suitability
Requirements and Best Practices
The Patient Experience and Impact to Current Processes
Agenda
Overcoming Adoption Barriers
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Question and Answer Period
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Industry Shifts
31
PAPER CRF EDC
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100% SDV/SDR RISK-BASED MONITORING
TRADITIONAL TRIALS DECENTRALIZED TRIALS
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The Evolution of Clinical Research Data
Greater
availability of
digital
patient data
Paper-based
CRF
1990 2000 2010 2020
Early adoption of
EDC
EDC
Maturity
Medical
Grade Devices
eSource
Virtual
trials
Consumer Grade
Devices
Mobile
apps
EHR
ePRO
Da
ta-D
rive
n R
ese
arc
h In
sig
hts
• Point data source
• Rise of data digitization
• Lack of connectivity
• Digital data revolution
• Cloud connectivity
• Orchestration of
multimodal digital patient
data
eConsent
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MORE CONFIRMED
DECENTRALIZED TRIALS
STARTED IN JUNE 2020
THAN ANY OTHER MONTH
ON RECORDDecentralized Clinical Trials in 2020:
A Global Survey
PharmaIntelligence Informa
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eConsent Defined
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THEDIGITIZATION
OF THECONSENTING
PROCESS
A DYNAMIC
AND
CONFIGURABLE
MULTI-MEDIA
SOLUTION
ENABLES
SHIFT OF TRIAL
ACTIVITIES
INTO THE HOME
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eConsent Multimedia Components
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SIGNATURE INTEGRATION
DocuSign, Adobe Sign, Free-form signatures
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KNOWLEDGE CHECKS
Provide knowledge checks to patients to ensure
understanding and identify gaps for discussion
VIDEO/ AUDIO CONTENT
Integrate video training and audio
recording into the app
DOWNLOADABLE ICF
Store and log any sessions recorded
in a secure environment
SUMMARY BOXES
Providing section highlights
ABC
LANGUAGE OPTIONS
Select language of preference for audio
content
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Benefits
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Sponsor/CRO
Site
Patient
► Decreased inspection findings due to improved version control
► Improved oversight via immediate notification of signed consent
► Timely monitoring of informed consent data
► Reduced CRA time on site
► Facilitates version tracking leading to fewer inspection findings
► Ensures consistent messaging to all participants
► Reduced administrative burden
► Self paced learning
► Ability to complete remotely
► Family, caregiver, LAR involvement in consent review
► Informed of updated information in timely manner
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The eConsent Continuum
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TRADITIONAL HYBRID FULLY DECENTRALIZED
+ ++
Protocol
Suitability & Risk
Assessment
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Subject Suitability
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Pediatric
Rare Disease
Visually Impaired
Language and presentation must
be understandable to a child
Reduced need for long distance
travel and patient inconvenience
Patient should have the choice
of paper based or eConsent
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Regulatory RequirementsModality Changes, Requirements Do Not:
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Ensure protection of the rights, safety,
and welfare of
human subjects
Facilitate the subject’s comprehension of
the information
presented during the
eConsent process
Ensure that appropriate
documentation
of consent is obtained
when electronic systems
and processes that may
employ multiple
electronic media are
used to obtain
informed consent
Ensure the quality and
integrity of eConsent
data included in FDA
applications and made
available to FDA during
inspections
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21 CRF Compliant
Restricted Access
Secure
Capture Date of Signature
Patient &
Investigator Team
VIRTUAL
PRE-SCREENING
& ASSESSMENTS
ECONSENT
& EASSENT
MEDICATION
ADHERENCE &
REMINDERS
ENGAGEMENT
EPRO /
ECOA /
EDIARY
REIMBURSEMENT
TELEMEDICINE
TRANSPORTATION
MOBILE NURSING
APPLICATIONS
MEDICAL DEVICE
INTEGRATION
GAMIFICATION
& REWARDS
INVESTIGATOR
ALERTS
Technology Platform Requirements
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Presenting eConsent to ParticipantsOHRP and FDA, eIC Must:
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Contain all elements required by FDA regulations
1 Be easy to navigate2 Use appropriate electronic strategies3
Provide copy to patient65 Permit questions and understanding checks4 Permit adequate time
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eConsent Administration
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SUPPORT PATIENT ENGAGEMENT PROCESSES
Support the consenting process and discussion, ensure
understanding
SCREEN SHARING
Allow the clinician to share any documents for discussion
LIVE DISCUSSION/INSTANT MESSAGING
Use other methods of communication for preference
TEAM CALLING
Support sessions that include the patient, caregivers, LAR
and clinicians
SUPPORT TECHNOLOGY NAVIGATION
Support patients with technology navigation as required
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Impact to Study Start-Up
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Process Flow
Decision to use
eConsent
Standard
process ICF
development
Site and Patient
training
Device
provisioning
eConsent
release to
Platform
EC submission/
approval
Materials
provided for EC
submission
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PATIENT
IDENTIFIED
FOR STUDY
CONSENT
DISCUSSION
PATIENT AND PI
PATIENT
SIGNS
CONSENT
PATIENT RECEIVES
eCOPY OF SIGNED
CONSENT
PATIENT DOWNLOAD
APP/ REVIEWS
CONSENT
PI SIGNS
CONSENT
PATIENT-DIRECTED
PI CONSENT
DISCUSSION
The Patient Experience: Remote
PI VERIFIES
PATIENT ID VIA
TELEVISIT
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1
2
3
4
5
6
PATIENT
IDENTIFIED
FOR STUDY
PATIENT
REVIEWS
CONSENT
WITHIN
PATIENT APP
PATIENT AND
PI CONSENT
DISCUSSION
PATIENT
SIGNS
CONSENT
PI SIGNS
CONSENT
PATIENT
RECEIVES
COPY OF
SIGNED
CONSENT
The Patient Experience: Onsite
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Centralized Monitoring of eConsent
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CRA logs into platform1Verifies that the approved versionof the consent is available
2Verifies approved versionused for each participant
3
Reviews source documents pertaining to consent
4 Verifies against EDC data5Review/collects regulatory documentation
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Overcoming Adoption Barriers
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Demonstrate success to ease concerns
Gather participant feedback
Build awareness around unchanged requirements
and similarities to paper-based process
Further regulatory guidance will ease concerns
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Key Messages
eConsent enhances the patient experience
A change in how consent is administered, not process
Fundamental principles and requirements do not change
Protocol and Subject Suitability must be assessed
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Paper ICF
• Complex language
• Long forms
Electronic Consent
• User-friendly navigation and content
• Review at patients own pace
• Integrated tools
• Targeted discussions
• Improved version control
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References
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•eConsent: Implementation Guidance (eConsent Initiative).
Transcelerate BioPharma Inc.
https://www.transceleratebiopharmainc.com/wp-content/uploads/2017/10/eConsent-
Implementation-Guidance.pdf
•Decentralized Clinical Trials in 2020: A Global Survey
•PharmaIntelligence Informa
•Use of Electronic Informed Consent: Questions and Answers:
Guidance for Institutional Review Boards, Investigators, and Sponsors
•Office for Human Research Protections, Food and Drug Administration
•https://www.fda.gov/media/116850/download
https://www.transceleratebiopharmainc.com/wp-content/uploads/2017/10/eConsent-Implementation-Guidance.pdfhttps://www.fda.gov/media/116850/download
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Question & Answer
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