Event

PSI Scientific Meeting: Decentralised Clinical Trials

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Date: Monday 23rd - Tuesday 24th January 2023
Time: 13:30-16:30 GMT (both days) | 14:30-17:30 CST | 08:30-11:30 EDT
Location:
 Online
Speakers: David Wright (AstraZeneca), Magnus Jörnten-Karlsson (AstraZeneca), Magalie Hilton (Roche), Yashoda Sharma (DiMe), Khadija Rantell (MHRA), Rima Izem (Novartis) and Rachel Williams (GSK).

Please note:- this event was originally scheduled to run between the 17th-18th October 2022, however has since been RE-SCHEDULED and will now take place on the 23rd and 24th January 2023. Please see full details below.

Who is this event intended for? Statisticians or those in other quantitative disciplines working on - or interested in - learning about decentralised clinical trials.
What is the benefit of attending? Attendees will hear about the application and opportunities of decentralised clinical trials in drug development from experts in the field, both statistical and operational.

Event cost

The fees for this Scientific Meeting are as follows;
Member rate = £20+VAT
Non-Member rate = £130*+VAT
*Please note: Non-Member rate includes membership for the rest of the 2022 calendar year, and the entirety of the 2023 calendar year.

Registration

To register for this event, please click here

Overview

In a decentralised clinical trial, patients’ assessments are (partly) transferred from the clinical trial site to the patients’ home and might occur without any face to face interactions between patient and study personnel. In particular during the Covid-19 pandemic, decentralising clinical trials attracted considerable attention as one way to continue conducting trials during lockdowns and curfews. In this online event, experts in the field discuss the opportunities and challenges of decentralised clinical trials for the development of drugs and the promise they hold for modernising the way trials are conducted.

Speaker details

Speaker

Biography

Abstract

Davidedit
David Wright (AstraZeneca)

Dr Wright became the Head of Statistical Innovation at AstraZeneca in September 2016. David leads a team of expert statistical methodologists who advise colleagues within AstraZeneca on novel trial design and analysis issues. Between 1999 and 2016 David worked for the Medicines and Healthcare products Regulatory Agency (MHRA) (formerly the Medicines Control Agency (MCA)) as a Statistical Assessor. David was Chair of the Biostatistics Working Party at the European Medicines Agency from 2011-2016.

What are Decentralised Trials? What are the key opportunities and risks with their use?

This talk with give an introduction to Decentralised Trials and outline some of the opportunities and risks they bring if conducted instead of site based/centralized trials.

Magnusedit
Magnus Jörnten-Karlsson (AstraZeneca)

Magnus is an Executive Product Director at AstraZeneca responsible for development and deployment of Digital Patient Solutions. He is accountable for development of Unify, an internal AstraZeneca solution to meet the needs of patients and HCPs participating in AstraZeneca Clinical trials.

Bringing true value to patients, site and sponsor through digital transformation of clinical trials.

To successfully support decentralized clinical trials we need to think holistically about designing a toolkit for patients and sites. In this talk I will touch on how we define, evaluate and select technology (medical devices); current progress on the tools, moving away from isolated silo tools that only deliver one thing to broader platforms; and the impact that is having on our sites and patients.

Magalieedit
Magalie Hilton
(Roche)

Magalie Hilton is a senior principal statistical scientist at Roche, Switzerland. She joined the company in 2009 and previously worked at a CRO in England. She has worked across several indications in oncology including in glioblastoma, pediatric and lung driver mutations drug development. Magalie has been involved in the setup, conduct and analysis of platform trials and this decentralised trial. She received her M.Sc. in Applied Statistics, Health and Social Sciences, at the University of Bordeaux (France).

ALpha-T: a Pre-Pandemic Decentralized Trial in Oncology.

ALpha-T is a Phase II, Open-Label, Single Arm trial with a decentralized (DCT) home-based approach. Patients with locally-advanced or metastatic ALK-positive non-NSCLC are enrolled. The collaborations involving the patients, the caregivers, the sequencing partner, the telemedicine company, the regulators and the Sponsor are key for the implementation of home-based solutions. Based on this case study example, top challenges and opportunities of a DCT will be presented.

Yashodaedit
Yashoda Sharma
(DiMe)
Yashoda Sharma is a Program Director at the Digital Medicine Society (DiMe), a 501(c)(3) nonprofit organization dedicated to advancing digital medicine to optimize human health. Dr. Sharma is applying her expertise from managing large, interdisciplinary collaborative programs, many of which align with promoting health equity and inclusion, to digital medicine. She is leading two DiMe initiatives; the Digital Health Measurement Collaborative Community and Diversity, Equity and Inclusion in Digitized Clinical Trials. The Digital Health Measurement Collaborative Community (DATAcc) brings together organizations from across the clinical research ecosystem, including the US Food and Drug Administration’s Center for Devices and Radiological Health, in a pre-competitive collaboration dedicated to realizing the full potential of digital health measurement as a tool to drive improvements in health outcomes, health economics, and health equity. Dr. Sharma’s previous work includes serving as a Principal Investigator for the All of Us Research Program at a Federally Qualified Health Center, Project Administrator for the NIDDK Inflammatory Bowel Disease Genetics Consortium at Yale School of Medicine and Administrative Manager in the Department of Genetics and Genomic Sciences at the Icahn School of Medicine. Digital Medicine - Opportunities for Advancing Health Outcomes and Health Equity.

Founded in 2019, the Digital Medicine Society (DiMe) is a global non-profit and the professional home for all members of the digital medicine community. Together, we drive scientific progress and broad acceptance of digital medicine to enhance public health. Digital medicine offers the potential to redefine healthcare, solving some of the most pressing and persistent challenges to good health for all. The digitization of healthcare presents a fleeting opportunity to move away from a system designed to treat the sick and toward one that is defined by each individual’s health. Core to our work of driving the development and adoption of digital health measurements is advancing health equity, to fuel the effectiveness of healthcare.

Challenges to effective and equitable clinical trials cannot be solved with individual entities working in isolation; multi-stakeholder, interdisciplinary expertise is required. DiMe partnered with the FDA and organizations across the healthcare continuum to prioritize inclusion in digital health measurement product development and deployment, and diversity, equity, and inclusion in digitized clinical trials. With this work we developed toolkits that healthcare and research organizations can incorporate into their current workflows to drive the adoption and implementation of digital and decentralized clinical trials, and best practices to ensure health resources are delivered with a health equity lens.

Khadijaedit
Khadija Rantell
(MHRA)
Dr Khadija Rantell (nee Rerhou) is a Senior Statistical Assessor at the MHRA. Khadija joined the MHRA in 2013.

At the MHRA, she writes assessment reports on methodological aspects of licensing applications, advises companies on methodological aspects of their clinical development programme, and contributes to the assessment of clinical trial applications and clinical investigations of medical devices.

Prior to joining the agency, Khadija worked in academia for over 10 years, where she taught statistics, both at undergraduate and postgraduate levels, and was involved in research across a wide range of therapeutic areas. She has a PhD in Applied Statistics to Healthcare Research from Sheffield University.

Khadija has a particular interest in early phase clinical trial designs, innovative trial designs, patient reported outcomes, real-word-data, and rare diseases. She is a member of the Patient Reported Outcomes Specialist Interest Group at the MHRA, the EFSPI (European Federation for Statisticians in the Pharmaceutical Industry) Scientific Committee, and the EFPIA/EFSPI Estimand Implementation Working Group (EIWG).

Towards more patient-centric trials: opportunities and challenges of decentralized clinical trials.

The COVID-19 pandemic has necessitated flexibility in trial conduct and accelerated changes in the clinical trial landscape. Decentralised clinical trials (DCTs) introduce new approaches to the conduct of clinical trials that aim to make clinical trials more easily accessible and convenient for participants to take part in. Moving forward, it will be important to leverage the use of more innovative tools and approaches to trial design, and conduct, including adoption of remote approaches such as electronic patient-reported outcomes, home visits by health staff, follow-ups over phone, telemedicine etc. This talk will cover key considerations for suitability of use of decentralised clinical trial model, reflecting on the opportunities and challenges of implementing decentralised elements in clinical trials.

Rimaedit
Rima Izem
(Novartis)

Dr. Rima Izem joined Novartis in 2021 as an Associate Director in the Statistical Methodology group in Analytics. There, she supports development and implementation of novel hybrid designs and statistical methods using real-world-data across therapeutic areas, and primarily in development and post-marketing. In her prior roles as faculty at Harvard University, reviewer and team leader at the US Food and Drug Administration, and faculty at Children’s National Research Institute she acquired a broad experience in clinical research and regulatory practice. This experience includes leading or contributing to several pioneering projects in comparative safety and effectiveness in the FDA Sentinel Distributed System, and comparative effectiveness research using rare disease registries.

Decentralized clinical trials: scientific considerations through the lens of the estimand framework.

While the industry and regulators’ interest in decentralized methods is long-standing, the Covid-19 pandemic accelerated or broadened the adoption and the experience with these methods in clinical trials. Potential benefits of decentralizing studies include broadening access of clinical trials to a more diverse population, reducing the burden of participation in trials, or using innovative endpoints. As decentralization is moving from a necessity to a choice, researchers need to consider the actual value added and implications of these designs beyond the operational aspects of their implementation

Our presentation illustrates how the estimand framework can clarify our thinking about those strategic decisions around decentralization. Those questions go beyond whether or not to decentralize, to how much and what to decentralize. That is, going through questions related to each attribute of the estimand, and especially population, treatment and variable, can guide the teams through a systematic thought process about the scientific opportunities, assumptions and potential risks associated with a possible use of decentralized components in the design of a trial. Illustrations from decentralized trial case studies will support the presentation and discussion of various considerations from this framework. Using this approach, teams can more easily calibrate the design decentralization complexity (from hybrid to fully decentralized) to the value added in answering scientific questions that could not be solely answered by an all on-site approach.

Racheledit
Rachel Williams
(GSK)

Rachel Williams is the Head of Opportunistic, ID, and Respiratory Epidemiology at GSK. She has over 20 years of experience in the pharmaceutical industry and sits on the Epidemiology and Patient Centered Outcomes Leadership Team at GSK. She has a PhD in Epidemiology from the University of North Carolina, where she is currently an adjunct assistant professor. Rachel has experience and interest in digital technology to collect patient-centric data, as well as how real world data can impact drug development.

Developing Digital Biomarkers: Application to Rheumatoid Arthritis.

Data collected in clinical trials present an incomplete view of disease activity due to daily symptoms fluctuation and heterogeneity. Digital technology can enable remote continuous monitoring and the addition of objective of patient assessments. Rheumatoid arthritis (RA) is a chronic condition with fluctuating symptoms allowing for feasibility assessment of digital biomarkers. First, we performed the PARADE study as the first in pharma to use the Apple Researchkit® for fully remote enrollment and data collection via the iPhone, including baseline information, symptoms, wrist movement, and a walk test. Based on this experience, we performed the weaRAble PRO study,enrolling patients through a clinic, and adding an Apple Watch as well as the iPhone for data collection. These studies indicate that digital technology allows for remote data collection, increased measurement frequency, a richer picture of disease activity, and a focus on patient centricity.

 

 

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