1.1 intro Tenaerts - Clinical Trials Transformation Initiative · clinical trial (reform) Patient...
Transcript of 1.1 intro Tenaerts - Clinical Trials Transformation Initiative · clinical trial (reform) Patient...
CTTI OverviewOne Decade of Impact. One Vision Ahead.
Pamela Tenaerts, MD, MBAExecutive Director
Feb. 6, 2018
#CelebrateCTTIDiscover how CTTI has influenced the clinical trials enterprise during the past decade.
Hear from other organizations about the benefits of applying CTTI recommendations successfully.
Learn how CTTI’s current work will impact and shape the future of clinical trials.
Public-Private PartnershipCo-founded by Duke University & FDA Involves all stakeholders
BetterStreamlined
Fit for purposeClinical Trials
Everyone must have a seat at the
table
ClinicalInvestigators
Industry (pharma,
bio, device, CRO, &
tech)
Academia
IRBsTrade &
Professional Orgs
Government &
Regulatory Agencies
Patients, Caregivers & PatientAdvocacy Groups
MULTI-STAKEHOLDER EV
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TRANSFORMING CLINICAL TRIALS Multi-Stakeholder
RESEARCH METHODS
STAKEHOLDER INTERVIEWS
FOCUS GROUP DISCUSSIONS
SURVEYS
SYSTEMATIC LITERATURE REVIEWS
EXPERT MEETINGS
We use quantitative & qualitative research methods, selecting those best aligned with each project’s objectives, to: Identify/describe “what is going on” to gain a
better understanding of a particular phenomenon.
Move beyond individual views to a more complete and objective understanding of the disincentives and motivators for change.
Equipped with data, we then challenge assumptions, identify roadblocks, build tools and develop recommendations to change the way people think about and conduct clinical trials.
MULTI-STAKEHOLDER EV
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TRANSFORMING CLINICAL TRIALS Evidence-Based2
MULTI-STAKEHOLDER EV
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TRANSFORMING CLINICAL TRIALS
Examples of Real-World Impact within Organizations
CTTI’s Central IRB tools & recommendations are used by organizations such as the National Institute of Neurological Disorders and Stroke (NIH) and North Shore-LIJ Health System.
CTTI’s Quality by Design framework is used by organizations such as AstraZeneca, DCRI, The Medicines Company, PCORNET, Pfizer, Target Health Inc. and University of Oxford.
The Cystic Fibrosis Foundation has applied CTTI’s recommendations to improve its DMC operations.
Eli Lilly is implementing CTTI’s informed consent recommendations through their new e-consent model.
UCB Bioscience is applying CTTI’s recommendations to develop mechanisms for implementing patient engagement strategies across the drug development life cycle.
CTTI and its work have been cited in:
Several FDA guidance documents
An EMA reflection paper
A NIH draft policy Congressional efforts
around 21st Century Cures legislation
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TRANSFORMING CLINICAL TRIALS Real-World Impact at the Policy Level
CTTI Organization
• Oversight and strategic direction
Executive Committee
• Input into strategy and project selection• Conducts projects and develops strategies for
implementation
Steering Committee
• Project support and organization in pursuit of mission
Staff
CTTI Membership
*Version: Jan. 29, 2018
Patient Engagement EvolutionPatient Engagement 1.0 Patient advocates on EC, SC, and project teams PLC established Jan 2013
• Increased patient representative participation• Patient reps began serving as team leads• Fast-tracked PG&CT project
Normed (no question) inclusion of patients as equal partners into every aspect of clinical trial (reform)
Patient Engagement 2.0 PLC full integration into the Steering Committee in 2015 Additional activities being explored Individual patients reimbursed for time on CTTI activities incl. projects
Patient/caregivers on project teams have played critical role in shaping many projects
NEW: CTTI and FDA launch Patient Engagement Collaborative
Almost all CTTI recommendations to date include a recommendation to involve all stakeholders particularly patients in the process
Evolution of CTTI Mission
To identify practices that through broad adoption will increase the quality and efficiency of clinical trials
To identify and promote practices that will increase…
To develop and drive adoption of practices that will increase…
2008
2013
2016
CTTI Projects
CTTI Methodology
Areas of StrategicFocus:
SYSTEMATIC EVIDENCE
GENERATION
PATIENTS AS EQUAL PARTNERS
EFFICIENT & QUALITY TRIALS
PUBLIC HEALTH
CONCERN
SAFE & ETHICAL TRIALS
Active Projects:
MCT Legal & Regulatory
MCT Mobile Devices
MCT Stakeholder Perceptions
Real World Evidence
State of Clinical Trials
Patient Groups & Clinical Trials
Investigator Qualification
ABDD HABP/VABP Studies
Complete Projects:
Large Simple Trials
MCT Novel Endpoints
Registry Trials
GCP Training
Investigator Community
Monitoring
Quality by Design
Recruitment
Site Metrics
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Long-Term Opioid Data
Central IRB,Central IRB Adv
DMCs
Informed Consent
Pregnancy Testing
IND Safety, IND Safety Adv
SAE Reporting
PROJECT PORTFOLIO
Areas of StrategicFocus:
SYSTEMATIC EVIDENCE
GENERATION
PATIENTS AS EQUAL PARTNERS
EFFICIENT & QUALITY TRIALS
PUBLIC HEALTH
CONCERN
SAFE & ETHICAL TRIALS
Active Collaborations:
Sentinel IMPACT-AFib Patient Engagement Collaborative
ABDD PTN
Complete Collaborations:
Clinical Trials for Comparative Effectiveness
Electronic Healthcare Data
Patient Engagement Survey
Clinical Trials Poll
FDA Training Course
Cardiovascular Endpoints
COLLABORATIONS PORTFOLIO
Road to Impact
CTTI Recommendations,
Resources, & Findings
Impact
Awareness
Adoption
CTTI Recommendations & Tools• Streamline Antibacterial
Pediatric and HABP/VABP Trials
• Organize DMCs to ensure patients’ safety
• Move Recruitment planning upstream to reduce barriers to participation
• Develop a better IND Safety Reporting system
• Perform higher quality Informed Consent process
• Involve Patient Groups as equal partners
• Apply Quality by Design (QbD)principles to create better protocols
• Improve ethics review process via use of Central IRB
• Reduce inefficiencies of investigator GCP Training
• Use Registries to conduct more efficient clinical trials
• Identify the best pathways for developing Novel Endpointsgenerated by mobile technologies
• Create Pregnancy Testing plans for improved clinical trials
• Strengthen the Site Investigator Community
Engage with CTTI Today
Participate in a project or driving adoption activity
Attend an upcoming CTTI webinar
Implement CTTI recommendations & resources
Share recommendations with others
Stay informed: Follow CTTI on Twitter and LinkedIn; share our news with
your followers & friends Sign up for CTTI’s monthly e-newsletter
www.ctti-clinicaltrials.org
THANK YOU.
#CelebrateCTTI@CTTI_Trials