CDISC Unveils Clinical Trial Registry Standard
The Clinical Data Interchange Standards Consortium (CDISC) announces the availability of a new standard allowing pharmaceutical companies to register their clinical trials from a single files into regulatory databases of the EMA, FDA and WHO.
The Clinical Data Interchange Standards Consortium (CDISC) has announced the availability of a new standard, Clinical Trial Registry (CTR) XML. The standard will make it possible to build applications that generate submissions of clinical research for multiple, global clinical trial registries; specifically the World Health Organization (WHO), European Medicines Agency (EMA) and to ClinicalTrials.gov from a single file. The CTR standard was inspired by the International Committee of Medical Journal Editors (ICMJE), and is based upon the 20-item WHO Trial Registration Data Set as well as EudraCT specific extensions, according to a statement from CDISC. It maximizes the re-use of existing CDISC transport standards by extending the Operational Data Model (ODM-XML) and including Study/Trial Design Model (SDM-XML) content. This makes the standard a more general solution that any trial registry can use as the means to populate their registry with structured content from a clinical trial sponsor's systems. The next stage will extend the standard, creating an underlying structured protocol standard, results summaries and Identification of Medicinal Products (IDMP) compliance (an ISO standard), to further increase the richness, reliability and traceability of registry information. Editor’s Note: CDISC is looking for volunteers and sponsors to join the CTR team for stage two. Contact phouston@cdisc.org for details. Read here for more information about CTR-XML http://www.cdisc.org/ctr-xml.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
