August 09 2023, 09:00 CEST
Since announcing the launch of the Digital Tools for Rare Disease project (DT4RD), a product of the Rare Disease Research call placed by the European Joint Programme on Rare Diseases in partnership with Fondation Maladies Rares sponsored by Chiesi and CSL Behring, extensive progress has been made!
Non-invasive tools for measuring rare disease patient mobility in daily living and distinguishing between voluntary and involuntary movements were put in place using state-of-the-art wearable sensors integrated with Aparito’s Atom5TM clinical trial platform to capture physiological and psychosocial parameters.
The main objective of this project has been focused on developing and validating a way to acquire, transfer, store and process heterogeneous data related to movement measured at home and anchored to assessments performed at the hospital, as Clinical Outcome Measures (eCOA).
This European study involves great collaboration with renowned clinical experts located at the Institute of Myology (Paris, France), and at the John Walton Muscular Dystrophy Research Centre (Newcastle, UK).
After the French Ethics Committee’s approval, the Institute of Myology is proud to announce their First Patient recruited into the study on the 3rd of July 2023!
The enrolment went very well although a bit longer than expected to explain in detail the protocol and train the patient with the digitised tools including the Atom5TM platform with video tasks and ePRO to complete, the Garmin Vivosmart5 wearable device and the Yumen Bionics wearable sensors.Dr Jean-Yves Hogrel, Director of the Laboratory of Neuromuscular Physiology and Evaluation at the Institute of Myology
The patient expressed her motivation for taking part in this study related to the mobility of patients affected by rare neuromuscular diseases. Afterwards, she declared: “I felt comfortable, not too tired and confident to carry the tasks at home independently”.
The Institute of Myology Team added: “We are in the process of recruiting very soon our next patient on the 1st of September 2023 and keep on enrolling a total of 20 patients in the next few months.”
This is a great milestone which reflects a wonderful collaboration to date. We are always grateful when patients enrol on our studies and appreciate their time and dedication to develop innovation that will hopefully be used in patient-centric clinical trials to convey what’s important to patients.Dr Elin Haf Davies, CEO of Aparito
By digitising critical procedures within the clinical trial process, Aparito leads this project with European Clinical partners as well as renowned technology and industry partners to provide real-time visibility of data collection and integrity, reducing patient and site burden, enhancing the patient experience, and improving patient retention.
This EJP-DT4RD study is supported by the Atom5TM platform’s innovative technology in the patient’s homes using disease-specific smartphone apps, video assessments, and wearable technology to deliver meaningful data through eCOAs and the development of digital biomarkers.
Aparito’s mission is to digitize clinical trials and accelerate drug development for patients with life-limiting diseases by supporting patient-centric clinical trials with innovative treatments. Clinical trials can be conducted within patients’ homes by leveraging our Atom5™ platform incorporating disease-specific smartphone apps, video assessments and wearable technology to deliver digital clinical trials using novel eCOA to generate continuous real-world data. Aparito’s patient-generated data platform is disease-agnostic and scalable, ready for rapid deployment in global rare disease studies.
About the Institute of Myology
The Institute of Myology, located in Paris, coordinates medical management, research, and education related to muscle diseases and injuries. It is an international reference centre that participates in numerous trials and clinical studies, with a focus on neuromuscular diseases, high-performance sports, and ageing. The Institute of Myology Association facilitates the coordination of site activities in partnership with five public guardianship organisations, and the institute includes a complete Center of Research in Myology and several scientific poles as well as clinical activities.
Find them on https://www.institut-myologie.org/en/
About the EJP-DT4RD project
A unique project involving Academics (Institute of Myology, John Walton Muscular Dystrophy Research Centre), SMEs (Aparito, Yumen Bionics), large pharmaceutical companies (Chiesi, CSL Behring), and a patient organisation (MSUK) working towards the same objective for and with patient involvement. It widens the horizon of tremendous possibilities for the future of research in rare diseases and warrants hope for future clinical trials using Real World data.