Events & Speaking Engagements
Enhancing patient-centric outcome measures and clinical trials with Digital Health Technologies, 12-13 December 2022 (online)
Building on the great momentum in Europe, with initiatives such as ACT-EU or the EMA Regulatory Science Research needs, and advances in IMI projects such as IDEA-FAST or Mobilise-D, EFPIA is organising a multistakeholder workshop on the use of Digital Health Technologies (DHTs) in drug development, with a focus on digital data including digital endpoints. This workshop will offer an opportunity to discuss how to optimise DHTs development, evidence generation for validation/qualification, and regulatory pathways, and to clarify some of the challenges faced so far.
To be held virtually on 8-9 November 2022, the workshop seeks to build a roadmap for enabling the use of DHTs in drug development in Europe and beyond. It will be designed with plenary sessions and interactive breakout sessions to integrate views and expectations of the various stakeholders, and to share learnings and solutions. Discover our draft agenda here.
This event is free to join. Register now to join the conversation.
ISPOR Europe 2022: Collaborating Across Borders: Building & Using Evidence to Enable Access, 6-9 November, Vienna, Austria and Virtual
On 7 November, 10:45-11:00 AM, Julia Kopanz (UMCU) will present on: Patient Preferences on Decentralization of Clinical Trials: Identifying Attributes in a Focus Group Study
Also on Monday 7 November, Julia will present the same paper from 12:30 to 13:15 pm CEST in the Student Poster Tour. You can find the poster here.
Clinical Trials Europe: Step Into The New Era Of Clinical Trials: Future-Proof Your Strategies To Ensure Clinical Trial Success, 7-9 November, RAI, Amsterdam
On 8 November at 14h00 CET, Mira Zuidgeest (UMCU) will present on: Decentralized Clinical Trials – Initial Learnings from Trials@Home and the RADIAL Study
- During this session we will discuss the topic of Decentralised Clinical Trial (DCT) approaches from several angles.
- What are the (perceived) opportunities and challenges of DCTs from different stakeholder groups?
- What can we learn from case studies with decentralised approaches?
- How do we intend to provide insight into some of these challenges and opportunities through the proof-of-concept-study RADIAL (a methodological study comparing decentralized approaches to conventional trial approaches regarding several KPI)
- What are the initial learnings from the submission and start-up of the RADIAL study
- Lastly, we will introduce ways forward for DCTs, as a start of for a Q&A
This in-person event is free to join. Register now to join the conversation.
DIA Clinical Trials and Data Science Conference, 19-20 October, Amsterdam
On 20 October at 11am CET, Mira Zuidgeest (UMCU) and Amos de Jong (UU) will be speaking in break out session 1A: Decentralised Clinical Trials on “Learnings from IMI Trials@Home”.
Later on in the day, at 4pm CET, Solange Corriol-Rohou will join the plenary session 2 “Patients as Partners – What’s in it for the Patient?”.
More info on how to register and the full programme can be found here
EMA ACT EU multi-stakeholder meeting on decentralised clinical trials, 4 October, Amsterdam (online)
The Accelerating Clinical Trials in the EU (ACT EU) programme is hosting a multi-stakeholder workshop on decentralised clinical trials (DCTs) on behalf of the EU DCT project, bringing together participants from all areas of the research community to share perspectives on this type of clinical trials.
During the workshop, the EU DCT project group will present the work of the European medicines regulatory network on decentralised clinical trials collaboration, including the planned publication of a recommendation paper on the use of decentralised elements in clinical trials in the fourth quarter of 2022.
The onsite workshop is open to invited participants only, but the workshop’s plenary sessions will be broadcast live on this website. Any interested party can follow this broadcast. A video recording of the plenary session is made available after the event. Processing and publication of the video recording typically take up to 60 days. The agenda of the meeting can be found here.
The Mobile Technologies in Clinical Trials Summit, 12 September, Boston
The Mobile Technologies in Clinical Trials Summit, taking place September 12th, Boston is designed for digital R&D professionals to get the best access to implementation strategies for applying mobile/digital tools to connect and empower patients, and obtain better outcomes in drug development/clinical research. Each year, we bring forward the latest experience-based case studies while presenting fresh ideas to advance fit for purpose, adoption and scale of remote digital solutions.
Kim Hawkins (Sanofi) joined the “REPORTING ON MOBILE/DIGITAL IMPLEMENTATION INITIATIVES AND DEMONSTRATING IMPACT” track to reflect on Trials@Home with a focus on the mobile/digital tools that will support RADIAL, and how they will impact/empower the patient.
On day two of the Informa event, Fatemeh Jami (AZ) presented a CASE STUDY: Review of DCTs Through the Lens of QA
On-demand access to all presentation recordings from June 14th and you can find her slides here.
FEATURING Trials@Home’s Kimberly Hawkins, Sanofi, on “Trials@Home Proof of Concept Study and a Sanofi Case Study”.
Monday, 6 June 2022 2:00pm – 2:30pm EST/EDT (Eastern Daylight, GMT-4)
Explore the various ways you can decentralize your clinical trials and get to grips with the associated challenges and benefits with guidance from leading industry experts at Decentralized Clinical Trials, June 6-8, 2022 in Miami.
The event is free to attend In-Person for Pharmaceutical, Biotechnology and Medical Device industry professionals and spaces are limited.
Make the most of the opportunity to address all of your DCT questions in one place by securing a free pass today!
20-21 April, Barcelona
IMI Trials@Home project aims to reshape clinical trial design, conduct and operations, by developing and piloting standards, recommendations, and tools for the definition and operationalisation of decentralised clinical trials in Europe. In its pilot study, RADIAL, we work with patients to assess and evaluate preferences and satisfaction around the concept of DCTs.
On 20 April at 10.15, Tanja Keiper (MERCK), Bart Lagerwaard (UMCU) and Maartje Roskams (IDF Europe) introduced the RADIAL trial and showed how we will approach questions on patient satisfaction on conventional compared to hybrid and DCT trial models, including specific patient-facing technologies.
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29-31 March, Brussels
29-31 March DIA Europe 2022 will take place in Brussels. The Trials@Home consortium is well-represented and there will be a dedicated “Decentralized Clinical Trials” poster session, during which research conducted by, amongst others, the EAGLE group will be presented; ‘the mock ethics review’ will be presented by Tessa van Rijssel and ‘the interview study with regulators’ will be presented by Amos de Jong. If you are planning on going to DIA Europe 2022, you are cordially invited to attend this session! Also, it may be a nice opportunity to meet some of the EAGLE colleagues in-person.
The session (#P01-L Live Oral Poster Presentations) will take place on Tuesday 29 March from 13.00-13.45 at the Regulatory Science Hub.
International Rare Disease Showcase
February 3, 2022 – online
At Beacon’s International Rare Disease Showcase, Trials@Home joined the Main Stage session on ‘The road to treatment: collaboration and innovation driving new rare therapies’. Here, Trials@Home presented about decentralised clinical trials to the conference’s 430 attendees, piloting the RADIAL study, and how this can benefit the field of rare diseases. You can rewatch the presentation here:
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DTRA Inaugural Annual Meeting
November 10-13, 2021
Trials@Home will participate in a panel session during the DTRA Annual Meeting on the DCT-related work of other initiatives. This panel is scheduled for Friday November 12th 9am ET at the Boston Encore.
Confirmed Speakers from the following critical initiatives:
- TransCelerate: Hassan Kadhim (BMS)
- IMI Trials@Home: Kimberly Hawkins (Sanofi)
- CTTI: Reem Yunis (Medable)
- ACRO: Kushal Gohil (Parexel)
- SCRS: Casey Orvin (CenExel)
This session will be a conversation facilitated by Amir Kalali and Craig Lipset. Goal of the session will be: (1) ensure the diverse DCT leaders across DTRA are aware of the important work of other related initiatives and (2) begin to explore opportunities for “meta-collaboration” across initiatives where appropriate. The latter point builds on a regular cadence of leadership meetings DTRA has been holding with each initiative over the course of 2021 to ensure transparency and the potential for hand-offs.
DTRA is looking forward to a safe and rewarding opportunity to learn, network, and advance work together. Those joining in-person will be vaccine-verified with on-site antigen testing; all content will be streamed online to ensure learning opportunities are broadly accessible.
For more info click here https://www.dtra.org/registration