BROADSTAIRS, England, June 10, 2019 /PRNewswire/ -- PHUSE, an independent membership society and non-profit organization created by volunteers who work in the pharmaceutical industry, announced today that it has successfully transitioned two guidance papers from TransCelerate BioPharma Inc. under its umbrella. These guidance documents address clinical data transparency and the de-identification and anonymization concerning individual patient data. As part of this transition, PHUSE is responsible for future updates to the guidance documents.
"Since our inception, PHUSE has grown from a conference for European statistical programmers to a global membership organization and platform," said Stephen Bamford, Founder and Chairman of the Board at PHUSE. "PHUSE can leverage our broader set of stakeholders around the globe to facilitate increased holistic thinking around these assets so these papers can live on in the research and development ecosystem. PHUSE and TransCelerate are similarly aligned in our missions and are thrilled that we can continue the good work that TransCelerate started five years ago."
TransCelerate BioPharma is a non-profit organization dedicated to improving the health of people around the world by streamlining and accelerating the research and development (R&D) of innovative new therapies. Accordingly, TransCelerate has undertaken a commitment to enhance public health and medical and scientific knowledge and streamline regulatory compliance by facilitating the sharing and transparency of clinical trial information.
The first paper, "Protection of Personal Data in Clinical Documents—A Model Approach," reflects the latest thinking on protecting privacy, including European Medicine Agency's Policy 0070 guidance issued in March 2016 to support the publication of clinical documents. It represented the current knowledge, experience and technology available at the time of publication. It also includes points for a sponsor to consider while determining the appropriate approach to protect personal data within clinical documents.
The second paper, "De-identification and Anonymisation of Individual Patient Data in Clinical Studies—A Model Approach (V2.0)," highlights which techniques are currently available to conform to existing directives and regulatory guidance and to respond to research requests while safeguarding the privacy of individuals for sharing in a non-public environment. This individual patient data paper better clarifies the data release context and expands sections considering the Expert Determination method, quantification of risk and technology needs.
"TransCelerate BioPharma's Clinical Data Transparency initiative was developed with the hope that these assets would be transitioned to an organization with the passion and wherewithal to govern them for the foreseeable future," said Liz Roberts, Senior Director and Global Public Policy Lead at UCB and member of Transcelerate. "PHUSE was a natural home as a working group structure already exists at PHUSE with representation from TransCelerate members. It's exciting to officially close out one of the first chapters of TransCelerate's history."
TransCelerate's third CDT paper, "Layperson Summaries of Clinical Trials: An Implementation Guide," and its supplemental tools will remain under the care of TransCelerate as part of its Clinical Research Access & Information Exchange initiative.
PHUSE provides collaboration tools and resources to encourage worldwide interaction. To read these guidance papers, visit https://www.phuse.eu/white-papers. The PHUSE Wiki, Archive, Newsletters, Webinars and Communication Library are available for members to read, share, listen to and research.
PHUSE is a non-profit, volunteer-supported, community of professionals who are passionate about the advancement of clinical information. Starting out as a conference for statistical programmers, PHUSE quickly launched itself as the premier platform for the discussion of topics encompassing the work of data managers, biostatisticians, statistical programmers and eClinical IT professionals. For more information, please visit www.phuse.eu, https://twitter.com/PHUSETwitta, or https://www.linkedin.com/company/phuse/.
About TransCelerate BioPharma, Inc.
TransCelerate BioPharma Inc. is a non-profit organization dedicated to improving the health of people around the world by streamlining and accelerating the research and development (R&D) of innovative new therapies. The organization's mission is to collaborate across the global biopharmaceutical R&D community to identify, prioritize, design, and facilitate the implementation of solutions designed to drive the efficient, effective and high-quality delivery of new medicines. The vast majority of TransCelerate solutions are publicly available. Headquartered in Philadelphia, TransCelerate has 20 Member Companies and 30 initiatives focused on improving the patient and site experience, enhancing sponsor efficiencies and drug safety, and, as appropriate, harmonizing process and sharing information.
Membership in TransCelerate is open to pharmaceutical and biotechnology companies with Research & Development operations. For more information, please visit http://www.transceleratebiopharmainc.com, https://twitter.com/TransCelerate, or https://www.linkedin.com/company/transcelerate-biopharma-inc-/.
PHUSE Communications Director
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