econsent in clinical trials - chrysalis advisory · ct:iq steering committee, 24 june 2019 econsent...
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Opportunities to enhance patient engagement
CT:IQ Steering Committee, 24 June 2019
eConsent in Clinical Trials
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01 | Project scope
02 | Methodology
03 | Background & context
04 | Use cases
05 | Benefits
Agenda
06 | Barriers to uptake
07 | Pathways forward - critical success factors
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1. Scope
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2. Methodology
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● Semi-structured interviews with 19 stakeholders
● Survey questionnaire, n = 179
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3. Background & context
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What exactly do we mean by eInformation and eConsent?
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How much exposure to eConsent have people had?
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1 eConsent with a physical
signature
2 eConsent on a supplied device
3 eConsent using cloud-based
software
4 eConsent using biometric
information
4. Use Cases
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Current usage of eConsent/Patient RegistrationA cluster randomised, crossover, non-inferiority trial of aspirin compared to low molecular weight heparin for venous thromboembolism prophylaxis and safety in hip or knee arthroplasty, a registry nested study -CRISTAL (ACTRN12618001879257)
Prof Ian Harris- UNSW
● Consent is to the data collection● Pragmatic design of SOC options● Patients can register either through a URL or an iPad● Questionnaires delivered through URL, iPad or through telephone interview.
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CALD
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Regional and Rural patients
● Teletrials still not widespread and won’t be achievable for all studies
● Patients will require stays in metropolitan centres● Eligibility screening and consent can be done remotely
○ Pre-reading may reduce time needed to go through the consent process- which may reduce the stay away from home
○ New information can be shared more easily
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5. Benefits
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What wasn’t seen as a significant benefit?
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6. Barriers to uptake
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What wasn’t seen as a significant barrier to uptake?
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7. Pathways forward - critical success factors
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7. Pathways forward - critical success factors
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1. What questions do people have?
2. Where to from here?
3. How might CT:IQ help to catalyze change and support adoption of eConsent?
Open Forum Questions
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Thank you.
t +61 2 9188 4080 | m +61 417 610 557e [email protected] | w chrysalisadvisory.com.au
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Nick NorthcottPartner BSc, BCom, MBA, GAICD
Nik ZepsExpert AdvisorBSc, PhD