the clinical trials transformation initiative: one decade

CTTI 10 YEAR ANNIVERSARY ONE DECADE OF IMPACT • ONE VISION AHEAD

~ 11111.. CLINICAL ""111111 ~ TRIALS .....ill~ TRANSFORMATION IIJ'III""" INITIATIVE

June 12, 2018

The Clinical Trials Transformation Initiative

One Decade of Impact, One Vision Ahead Pamela Tenaerts

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1 CTTI 10 YEAR ANNIVERSARY ONE DECADE OF IMPACT • ONE VISION AHEAD

Improving Clinical Trials

Public-Private Partnership

Co-founded by Duke University & FDA

Involves all stakeholders

80+ members

MISSION: To develop and drive adoption of

practices that will increase the quality and

efficiency of clinical trials

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N IVERSARY TTI 10 YEAR A~ONE VISION AHEAD C E OF IMPACT ONE DECAD

RANSFORMING ~LINICAL TRl~S THROUGH 3 K

STRENGTHS

Multi-Stakeholder

Better

Streamlined

Fit for purpose

Clinical Trials

Everyone is

an equal

partner at the

table

Clinical Investigators

Industry (pharma,

bio, device, CRO, &

tech)

Academia

IRBs Trade &

Professional Orgs

Government &

Regulatory Agencies

Patients, Caregivers & Patient Advocacy Groups


CTTI Membership

*Version: May 7, 2018

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Evidence-Based

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.

RESEARCH METHODS

STAKEHOLDER INTERVIEWS

FOCUS GROUP DISCUSSIONS

SURVEYS

SYSTEMATIC LITERATURE REVIEWS

EXPERT MEETINGS


Examples of Real-World Impact within Organizations

CTTI’s Single IRB tools & recommendations are used by organizations such as the National Institute of Neurological Disorders and Stroke (NIH) and Northwell Health.

CTTI’s Quality by Design framework is used by organizations such as AstraZeneca, Duke Clinical Research Institute, 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.


Real-World Impact at the Policy Level

CTTI cited in:

EMA reflection paper FDA guidance documents ICH reflection paper NIH draft policy Congressional efforts

around 21st Century Cures legislation


ICH Reflection on "GCP Renovation" : Modern ization of ICH E8 and Subsequent Renovation of ICH E6 , "- , New,=m ,"' 12wiu.ry2011

ICH is inviting public review and a:JIMlenl on II reflection paper on Good Oinical Prxtice (GCP) "Renovation', which conlain11 the ICH

proposal for further modernization of the ICH Guxlelines related to dinic:al trial deaign, planning, management, and conduct. The scope of

the proposed renovation include!I the current ES General Consideration, fo, Olnlcal Trials and further revision to the E6 Guideline fo, Good Clinical Practice, which is alraady undtlrgoing modernization with the racent production d ICH E8(R2).

The reflection paper is available lor download via the following Wnlo::

• Rellection paper on GCP Renovation

Draft NIH Policy on the Use of a Single Institutional Review Board

(slRB) for Multi-Site Research NI H's proposed a policy that NIH funded institution will be expected to use a single IRS of reccrd for domestic sites of multi-site studies funded by NIH whether supported through grants or contracts (as well as the NIH intramural program).

The goal of the proposed policy Is to enhance and streamline the process of IRS review and reduce administrative burden so that research can proceed efficiently without compromising ethical principles and protections

Compliance with this Policy will be a tenm and condition in the Notice of Award and a ccntract requirement in the Contract Award. Some exceptions will be penmitted on a case-by-case basis.

Comact Login

Seaf"dl Our Sire

CTTI Methodology

State Problem IDENTIFY RESEARCH IMPEDIMENTS

Issue Statement & Project Plan

Gather Evidence IDENTIFY GAPS/BARRIERS

Literature Reviews, Surveys, & Interviews

Explore Results ANALYZE & INTERPRET FINDINGS

Team Meetings

Finalize Solutions DEVELOP RECOMMENDATIONS/TOOLS

Team, Expert, & Ad Hoc Committee Meetings

Drive Adoption DISSEMINATE & IMPLEMENT

Pilot Studies, Measure Impact, & Implementation



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 Single IRB

• Reduce inefficiencies of

investigator GCP Training

• Use Registries to conduct more

efficient clinical trials

• Identify the best pathways for

developing Novel Endpoints

generated by mobile technologies

• Create Pregnancy Testing plans

for improved clinical trials

• Strengthen the Site Investigator

Community

Project Portfolio

Areas of

Strategic

Focus:

SYSTEMATIC

EVIDENCE

GENERATION

PATIENTS

AS EQUAL

PARTNERS

EFFICIENT &

QUALITY

TRIALS

PUBLIC

HEALTH

CONCERN

SAFE &

ETHICAL

TRIALS

Active

Projects:

MCT Decentralized

Clinical Trials

MCT Mobile

Technologies

MCT Stakeholder

Perceptions

Real World Evidence

State of Clinical Trials

Patient Groups

& Clinical Trials

Investigator

Qualification

ABDD

HABP/VABP

Studies

Complete

Projects

(now driving

adoption):

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

Single IRB,

Single IRB Adv

DMCs

Informed Consent

Pregnancy Testing

IND Safety, IND

Safety Adv

SAE Reporting

1 CTTI 10 YEAR ANNIVERSARY ONE DECADE OF IMPACT • ONE VISION AHEAD Driving adption priorities in green


11am ~ 111111... CLINICAL ""'1111111111 ~ TRIALS ...111111111 ~ TRANSFORMATION ~ .,..... INITIATIVE

THANK YOU.

Pamela Tenaerts

[email protected]

www.ctti-clinicaltrials.org

mailto:[email protected]

the clinical trials transformation initiative: one decade

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