IEEE-ISTO Announces a New Alliance to Advance Clinical Research Data Sharing
PISCATAWAY, N.J., Jan. 12, 2022 (GLOBE NEWSWIRE) -- Sharing clinical research data more widely has become a global priority. A group of leading BioPharma companies, academic institutions, and non-profit data-sharing platforms have come together to establish the Clinical Research Data Sharing Alliance (CRDSA). CRDSA is a multi-stakeholder alliance formed as a member program of the IEEE Industry Standards and Technology Organization (ISTO), an international federation of leading industry consortia dedicated to the advancement of standardized technologies.
Launched in August 2021, CRDSA’s mission is to accelerate the discovery and delivery of therapies to patients by expanding the research value of the high-quality data collected through the clinical trial process. Broad access to these data has the potential to transform the research process, improve trial design and delivery, and help benefit the patients who donate their time and their data as part of the clinical development process.
“When participating in a clinical trial, patients make a major commitment, including investing their time and sharing valuable information," said Virginia Nido, Global Head of Industry Collaborations at Roche, and member of the CRDSA Board of Directors. “We have an ethical obligation to make full use of the patient data we collect while respecting patient’s rights to privacy and data protection. By doing this we can maximize the reuse and value of these data to drive new R&D insights and accelerate drug discovery.”
As a multi-stakeholder alliance serving the clincal data-sharing ecosystem, CRDSA creates a neutral forum for organizations to collectively address the logistical, cultural, and policy challenges faced by both data contributors and research users.
“CRDSA is heeding calls from the World Health Organization and other Health Regulators for clinical trial and clinical research organizations to share data more widely and openly,” said Bron Kisler, CRDSA Chief Executive Officer. “We will achieve this by developing clear solutions to address known challenges, balancing the need to make data as scientifically useful as possible while protecting patient privacy.”
In 2021, CRDSA launched four Work Streams focused on Policy and Advocacy, Secondary Use Standards, Innovation and Technology, and Data Protection. These Work Streams address specific challenges that have been identified as priorities and are designed to support long-term objectives with actionable and achievable deliverables. This will result in consensus-based solutions that have broad multi-stakeholder support, are applicable across data sharing platforms, and can serve as an accepted best practice reference point for data contributors.
Marco W. Migliaro, IEEE-ISTO president and CEO stated, “CRDSA provides a collaborative forum for stakeholders to develop solutions to problems faced in the sharing of clinical research data. ISTO is pleased to support this important initiative.”
CRDSA serves as a unified voice across the data sharing ecosystem with a diverse membership. CRDSA’s Founding Members are Roche, Amgen, UCB, Takeda, Novartis, AstraZeneca, Vivli, Critical Path Institute, Project Data Sphere, University of Chicago, Duke Clinical Research Institute, d-wise, and Health Data Research UK. CRDSA is welcoming members from across the data sharing ecosystem to join this network and contribute to the transformation of data sharing. To get involved, visit https://crdsalliance.org/.
ISTO provides today’s industry alliances and trade associations with turnkey legal and operational support. Provided by an award-winning staff, ISTO provides a legal infrastructure for incepting organizations and offers best practice operations management, enabling organizational stakeholders to focus on the work at hand. ISTO is the premier trusted partner of the global technology community for the development, adoption, and certification of industry standards and technology solutions that benefit industry. An international federation of member programs, its mission is to facilitate the life-cycle of industry standards development through a dedicated staff committed to offering vendor neutrality, quality support and member satisfaction. ISTO Programs span the spectrum of today’s information and communications technologies. For more information, visit ieee-isto.org.
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