Modern clinical trials have become incredibly complex, often requiring extensive assessments on niche populations. With studies placing such a significant burden on patients it is no surprise that recruitment and retention of trial participants remains an ongoing challenge. While clinical trials may never be easy, patient-centric study design, incorporating patient feedback and operationalization with the right technologies can alleviate barriers and increase accessibility.
The US Food and Drug Administration (FDA) Patient-Focused Drug Development (PFDD) program is a systematic approach to engaging patients throughout the drug development process. While nearly everyone agrees with the aspirations of PFDD, practically implementing patient-centric approaches across the clinical development process can present real obstacles. These include early challenges like creating or identifying the right clinical outcome assessment and integrating them into the overall study design, listening to patients early and often for protocol refinement and recruitment, and operationalizing studies that ultimately work for the needs of a specific population. The featured speakers will share their extensive practical experience across the clinical development process in implementing PFDD.
Join this webinar to hear about strategies for developing patient-centric clinical outcome assessment and trial designs, methods for listening to patients throughout a trial and practical guidance on operationalizing a study for patient-centricity.
Speakers
Fabio Gratton, Cofounder and CEO of inVibe Labs, a Division of THREAD
Fabio Gratton, Cofounder and CEO of inVibe Labs is a digital health entrepreneur. For over two decades he has adapted his early experience as a Hollywood scriptwriter with innate acumen in science and data to redefine how healthcare companies tell patient stories through technology. Of his many Fortune 5000 ventures, inVibe has redefined qualitative market research by enabling brands to supplement their efforts with flexible, scalable and impactful voice-driven insights.
Message Presenter
Noah Goodson, PhD, Director, Consulting, Decentralized Study Design Lead, THREAD Research
Dr. Noah Goodson is a scientist, consultant and thought leader in the clinical research space. He hosts two podcasts, Life Science Today covering stories, insights and trends, as well as Clinical Research Evolved where he interviews subject-matter experts. Noah is a Director of Consulting and Decentralized Study Design at THREAD. Prior to joining THREAD, Noah helped early-stage biotech and medical device companies design and execute hybrid and fully decentralized research. He is well versed in the complex business needs of biopharma and has spent significant time guiding scientific strategy with investors as a consultant and board member.
Message Presenter
Kim McLean Boericke: Chief Delivery Officer, THREAD Research
Executive drug development delivery turned digital health delivery executive, Kim’s career spans 25+ years leading global drug development, clinical research, medical device and diagnostics and decentralized clinical trials (DCTs) for life science organizations from early development through market authorization.
As Chief Delivery Officer of THREAD, Kim leads the technology enablement consulting services which design, define operational readiness, configure and launch the THREAD digital platform. Her team is focused on delivering to THREAD’s 1/5/30 mission to modernize clinical research by offering biopharma, device and diagnostics and CRO customers one (1) comprehensive platform that is five (5) times more inclusive and makes research 30 percent more efficient.
Kim joined THREAD from her last position at ICON, where she started as the Global Head of Project Management, moved to President of Commercialization and Outcomes and served as part of the executive leadership team. Additionally, she was also the Global Head of the Decentralized Clinical Trial Solutions unit responsible for advising, planning and delivering decentralized clinical trials across many different platforms. Prior to her years at ICON, she worked at ClinTrials, Quintiles, INC Research, Duke Clinical Research Institute and i3 Research.
Kim is a champion of patient-centricity, recently serving as the Chairwoman of the Board for Mapi Research Trust and continues to serve as an Independent Director. In addition, she was part of the executive steering committee for the Diversity, Inclusion and Belong initiative at ICON. She served as the executive sponsor for the Network of Women (NOW) and for PRIDE.
Message Presenter
Stefan Cano, Chief Scientific Officer, Modus Outcomes, a division of THREAD
Stefan is a Chartered Psychologist and Associate Fellow of the British Psychological Society. He has 27 years’ experience in patient-centred outcome research across a range of clinical and surgical disciplines. Stefan’s main area of interest is in developing, applying and improving mixed methods psychometric research in clinical studies and therapeutic trials. He is especially interested in maximizing the interpretability of existing and new patient-centred outcome instruments.
Stefan is also co-developer of Q-Portfolio patient-reported outcome (PRO) instruments (including BREAST-Q(c), FACE-Q(c), BODY-Q(c) and CLEFT-Q(c)), which have been used widely in clinical research, trials, practice, guidance, registries, audits and quality improvement initiatives. Stefan has co-authored 200 articles in patient-centered outcome research in peer review journals (H-Index 59;).
Message PresenterWho Should Attend?
- Clinical Research
- Clinical Project Managers
- Data Management
- Decentralized/Remote/Virtual Trials
- Digital Innovation/Strategy
- IT
- Medical Director
- Patient Experience
- Patient Engagement
- Patient Recruitment
- Trial Design
- Therapeutic Head/Lead
What You Will Learn
Attendees will learn about:
- Developing patient-centric clinical outcome assessment strategies
- Developing patient-centric trial designs and protocols
- Listening to patients and incorporating their feedback for better recruitment and retention
- Operationalizing hybrid and fully decentralized trials for patient-centricity
Xtalks Partner
THREAD
THREAD is a leading provider of a proprietary, decentralized research platform and suite of supporting services used by biopharma, CROs and life science organizations to remotely capture data from participants and sites during, in-between and in lieu of in-clinic visits. THREAD’s platform and supporting services are helping customers to shorten study launch timelines, reduce study budgets with Virtual Visits, and bring studies from the clinic to patients’ homes. THREAD provides key platform features such as eConsent, eCOA/ePRO, sensors, reminders, and telehealth Virtual Visits to support remote data capture, hybrid virtual studies, and fully decentralized studies in key therapeutic areas. In 2019, THREAD was acquired by strategic health care investors Water Street Healthcare Partners and JLL Partners. Visit us at https://www.threadresearch.com/
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