Standards in Sync: Accélérer la Recherche Médicale – Webinaire EUCROF

25 septembre 2024 de 16h00 à 17h30 (CEST)

Webinar Overview

It has been demonstrated that using standards from the start of clinical research studies (i.e. protocol and CRF development) can save significant time and resources and results in higher quality research. Unfortunately, it is not always clear how to select the appropriate standards for the purpose and how to ensure they are robust and will achieve the desired goals. All too often in the standards development world, we are faced with competing standards, new ‘standards’ development when standards already exist, or mapping data into a standard after the study has ended. These redundancies and inefficient methods incur costs in terms of resources, money and, in some cases, risks to patients (i.e. all of us). They may also have a negative effect on the data. This workshop is the first of a series of 3 and is organized in the context of xShare, a three-year Horizon Europe project that envisions expanding the European Electronic Health Record exchange Format (EEHRxF) to improve interoperability within the European Health Data Space (EHDS). It is the hope that these new interoperability capabilities and this collaborative work will enable a greater alignment of data quality between care and research, to transform data into valuable knowledge with benefits for all. We will cover the research use cases that are the focus of xSHARE and the standards that are being employed in a synchronized manner.

Attendees of this webinar will learn:
a) Overview of the EU xSHARE project
b) Rationale and benefits of using standards in the planning stage of clinical research studies
c) Characteristics of robust standards and achieving semantic interoperability at the source
d) Examples of complementary implementation of standards, including xSHARE
e) Five principles of developing and implementing synchronous standards

Presenters

Rhonda Facile ​

VP, Partnerships and Development

CDISC

Rhonda Facile is currently VP, Partnerships and Development at CDISC where she oversees strategy and new project development. Rhonda has over 25 years of clinical operations experience. She has worked in a global CRO, pharmaceutical and biotechnology companies in the United States and abroad.  She has experience in clinical trial monitoring, program management, regulatory affairs and standards development.

At CDISC, Rhonda brings together, key and diverse stakeholder communities, including the clinical community, global regulatory authorities, national health agencies, global biopharmaceutical and vendor organizations to forward clinical informatics and the use of CDISC standards.  Rhonda represents CDISC at ISO TC215, the HL7 Accelerator Vulcan Operations Committee and at numerous other collaborative organizations and partnerships.

Ms. Facile holds an MS from St. Edwards University and a BA from the University of Texas at Austin.

Rhonda has instantiated the body of peer-reviewed articles on CDISC standards implementation published in the Journal of the Society of Clinical Data Management (SCDM) and has authored and co-authored publications that are published in journals such as Journal of Medical Internet Research (JMIR) and Drug Discovery, and in several meeting proceedings.  Rhonda also contributed to chapters in the textbook Achieving Diversity, Inclusion, and Equity in Clinical Research Guidance Documentation 1.1, Cambridge and Boston, MS: Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center), published in 2021.

 

Rebecca Daniels ​Kush

Founder and President Emeritus

CDISC

Rebecca Daniels Kush is currently President of Catalysis and Founder and President Emeritus of the Clinical Data Interchange Standards Consortium (CDISC). She is on the Board of the Learning Health Community; serves as an Associate Editor of the Learning Health Systems Journal (Wiley); and, chairs the Advisory Council for the Vulcan HL7 FHIR Accelerator.

Dr. Kush served for 20 years as President and CEO of CDISC, which was formed as a volunteer group in 1997 and was incorporated as a 501c3 non-profit standards development organization (SDO) in 2000. CDISC Europe Foundation was founded in 2011, enabling participation in IMI and EU collaborations.  CDISC has developed and harmonized a suite of global clinical research data standards to support clinical research in therapeutic areas that affect well over 1.5 billion lives. These standards are required for the submission of data to support regulatory reviews and approvals of new products by the U.S. FDA and Japan’s PMDA and are endorsed by other regulatory agencies (EU, Korea and China).

Dr. Kush retired from the leadership position at CDISC in 2017 and spent six years as Chief Scientific Officer for Elligo Health Research, a start-up in Austin, TX focused on expanding research opportunities to community clinicians and leveraging healthcare data for research.  She participated in two FDA grants associated with the harmonization of common data models and identifying academic data partners to test use cases for these projects.

Prior to founding CDISC, Dr. Kush worked with the U.S. National Institutes of Health (NIADDK center at the Indian Medical Center in Phoenix, Arizona); a global clinical research organization (CRO); and biopharmaceutical companies headquartered in the U.S. and Japan. She served for five years on the U.S. Federal Health IT Standards Committee (HITSC), three years on the DIA Board, four years on the HL7 Board and was also on boards for ACRES, Litmus Health and Saama (an AI/technology company).

Dr. Kush earned her doctorate in Physiology and Pharmacology from the University of California San Diego School of Medicine and a B.S. in Biology and Chemistry with honors from the University of New Mexico.

She has authored publications that are published in journals such as New England Journal of Medicine, British Medical Journal, Science Translational Medicine, International Clinical Trials, Journal of Biomedical Informatics, DIA Journal, Applied Clinical Trials, and the Learning Health Systems Journal. She edited and authored chapters for a CenterWatch book on eClinical Trials and authored chapters for three editions of the Springer Clinical Research Informatics textbook, the latest released in 2023.

Attendance Fee

The participation in this webinar is free of charge.

Deadline for registration

24 September 2024 at 6:00PM

How to register?

1) Go on the REGISTRATION PAGE and click on the red button « RESERVE A SPOT »

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Confirmation

You will receive 2 confirmation emails:

A) One from Eventbrite with your invoice

B) One from « LiveStorm », the day before the webinar, with all the necessary information to connect the D-Day!

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