Patient-Centered Clinical Trials
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1 -Centered Clinical Trials Perfecting the Clinical Trial Optimization (CTO) framework Dr. Lynn Hagger Engagement Director, Respiratory & INA, AstraZeneca
2 Consistent -Centered Research Framework in Clinical Ops Trial Result Summaries Exit interviews Thank you notes Early Access Programs Inform patients on access & future research opportunities III POST STUDY I STUDY PLANNING OPEN & SUSTAINED RESPECT & COMPASSION EXPERIENCE & OUTCOME Yeoman G, et al. BMJ Innov 2017;0:1 8 Engagement Within Study Engagement apps (retention or adherence) TRACE trial guide Trial Experience Surveys II Insight into Protocol Development STUDY DELIVERY On-site Study Visit Simulation Preference and Adherence 2017, 11: Advisory Boards Partnership Program Online patient community Ultimate goals of CTOs Meet protocol approval and study initiation targets No amendment to protocol postapproval Accelerate recruitment Improve patient retention and protocol compliance
3 On-site Study Simulations: lupus Ph2 and Ph3 Methodology 18 patients (6 African American, 12 Caucasian) with dx SLE or LN Two study sites (Atlanta, GA and Altoona, PA) Simulate informed consent procedure, a mock screening visit, a mock dosing visit, and a debriefing period for patients and staff. s and staff interviewed to obtain sentiments and perceptions related to the simulated visits. Findings s desired: Simple background material (hard copy and online) Knowledgeable and trusted staff Personal results available after study Comfortable settings Value patient s time and greater scheduling flexibility Transportation and child care help during the visits Confidentiality of patient data Value and challenges Using these results, improvements study procedures to increase retention, recruitment, and compliance for clinical trials However, the on-site simulation was very expensive and time consuming for professional staff, patients, and AZ with few recommendations requiring an on-site study simulation.
4 CTOs using patient advisors or patient communities Gather data regarding patients experiences, perceptions, and feedback on the description of a particular study design or protocol ONLINE PATIENT COMMUNITY Phase3 study for s with severe Nasal Polyposis Simplify protocol design: -Simplify the visit procedures and PROs -Source medication centrally so patients receive it at the site Enhance site conduct of study procedures: -Study portal for sharing study documents and information -Difficult procedures only in experienced sites and read centrally -All epro questionnaires to be done at home by patient PATIENT PARTNERS or ADVISORS Phase 2b Type-2 Diabetes Mellitus Simplify protocol design: -Home delivery of medication for the subjects -Remove certain PRO s and reduce frequency of admin Enhance site conduct of study procedures: -Study portal for sharing study documents and information -Develop a visit guide, visit calculator Enhance clarity of study documents for patients: -Simplification of Informed Consent Form -Implement information booklet and website -Capture correct symptoms and use laymen terms in diary Enhance clarity of study documents for patients: -Simplification of Informed Consent Form -Implement information booklet and website -Provide patients with a simple study app Improve study experience for patients: - support in travel arrangements and costs -Minimize number of site visits -Lay Language summary at the end of the study Improve study experience for patients: - support in travel arrangements and costs -Provide trial experience survey pre-, during and post-trial 4
5 Measuring patient sentiment experience in a clinical trial impacts four generalized dimensions Empowerment through information s feel better when they have access to understandable, meaningful and relevant information; Understand the study Exploit the opportunity to learn about disease status Disease management Social empowerment Information, communication, and education Responsiveness to needs s as individuals Are the needs, values and preferences of the patient taken into account? Physical comfort Emotional support Logistics Responsiveness resilience Quality of care, medical and extra-medical How are the vulnerabilities of patients being addressed? Transportation / physical access Scheduling / availability Access to physician Waiting times Visit efficiency Access to care and coordination of care Continuity and transition Entering and leaving a study Knowing what will be different during the study and afterwards; Follow-up and aftercare Transparency on outcomes Personal progress during study 5 Based on Picker and the IoM frameworks for measuring patient centered care
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