Working Group Scope | More than 30 participants Active since 2014 the Data Transparency Working Group is made up of more than 70 active members from pharmaceuticals, | CRO’sCRO’s, software and academia, as well as CDISC and data privacy experts. Team members have since collaborated on developing a data de-identification standard for SDTM (known as | the ‘PHUSE the ‘PHUSE de-identification standard’). Since then, the | project Working Group has expanded to address EMA Policy 0070 matters, create a Data Transparency Roadmap across jurisdictions, and has started to address aspects of GDPR that are relevant for the conduct of clinical trials. The Data Transparency | Working Working Group also reviews, on a regular basis, draft deliverables, or guidance documents from regulatory bodies ( | eg, e.g. the EMA, Health Canada), as well as other industry organisations such | at as TransCelerate, and academia ( | eg, Cochrane).
Current Projects
Clinical Trials Data Transparency Toolkit
Terminology Harmonisation in Data Sharing & Disclosure Deliverables
Data De-identification Toolkit
Policy, Guidance & Materials Review
PHUSE De-identification Standards
Synthetic Datae.g, Cochrane). In addition to the projects PHUSE have continued to strengthen its place as the world’s largest home for data transparency events, by sharing vital knowledge of the field and creating a space where questions can be asked, and challenges addressed. The events look to meet the ongoing needs of data transparency within the clinical development arena and features thought-provoking presentations, panel discussions and Q&A sessions from experts in the data sharing field. |
Resources
Click here to search for all Data Transparency deliverables, past projects are housed under the archived section. |
Jean-Marc Ferran: Working Group Lead
Jean-Marc Ferran is an Independent Consultant based in Copenhagen with more than 15 years of experience in the Life Sciences industry. Prior to starting his company, Qualiance, he worked as a Statistician, Standards Manager and Director of Statistical Programming at Novo Nordisk and Ferring Pharmaceuticals. Jean-Marc has led the PHUSE Data Transparency Working Group since 2014 and is an appointed member of the EMA Technical Anomymisation Group and Health Canada Stakeholder Reference Group on Public Disclosure of Clinical Documents. Jean-Marc also chaired the PHUSE Annual Conference in 2012 in Budapest, was a Director on the PHUSE Board from 2014 - 2017, and is a Lifetime Honorary member of the society for his significant contribution to the organisation over a number of years. | Stephen Bamford: Working Group Lead
Stephen is the Head of Clinical Data Standards & Transparency at the Janssen Pharmaceutical Companies of Johnson & Johnson. Stephen has been a member of the Janssen team since 2016 and has helped to implement and support a number of data-sharing initiatives during this time. He has over 25 years of experience in the management of clinical trial and research data with pharmaceutical, life science and research organizations. In 2004, Stephen founded the PHUSE organization. From inception, he has driven and continues to drive PHUSE, which now has over 10,000 global members. PHUSE runs over 25 well-attended events globally each year, including a data innovation symposium in partnership with the Food and Drug Administration. | |
Sarah BalayDevaki Thavarajah : Working Working Group LeadLead shewitt@privacy-analyticsdevakit@outlook.com
Dr. Sarah Balay is a Senior Anonymization Expert and Technical Lead with Privacy Analytics’ Clinical Trial Transparency (CTT) business unit. Sarah completed her PhD in Neuroscience from the University of Ottawa in 2016. She studied mechanisms of neuronal death in the laboratory of Dr. David Park and was the recipient of numerous scholarships and awards during her graduate studies. Sarah joined Privacy Analytics in the earliest days of CTT. Her numerous skills gained during her time at the University of Ottawa, such as problem solving, multi-tasking and keen attention to detail proved ideal to help Privacy Analytics parlay its CTT expertise in data de-identification. Her expertise and work ethic have helped to shape the company’s CTT methodology and the toolsets that enable the team to meet clients’ most stringent deadline requirements. Currently she leads a dedicated team of Anonymization Analysts in the anonymization of unstructured data from over 800 clinical trials and is a guiding hand for one of Privacy Analytics’ most complex and demanding pharmaceutical client engagements. | Shannon Lefaivre: Working Group Lead
Shannon Lefaivre is a Data Privacy Technical Lead at Hoffmann-La Roche where she collaboratively supports the internal and external sharing of clinical trial data assets. Prior to joining Roche, she held positions at Halton Region (municipal government) and the Ontario Brain Institute. As a Health Information & Privacy Analyst at Halton Region, she was responsible for overseeing the privacy and information management of the public health portfolio. As the Program Lead, Informatics Governance at the Ontario Brain Institute she managed the privacy and data governance program for the neuroinformatics data sharing platform, Brain-CODE. Shannon has a MSc in Kinesiology and performed research related to Parkinson’s Disease at the Movement Disorders Research and Rehabilitation Centre in Waterloo, Ontario. | |
| Resources | ||
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Devaki partners with pharmaceutical clients, members of the research and healthcare community globally to help meet their clinical trial transparency and disclosure requirements. She has 8 years’ experience within the pharmaceutical and healthcare industry. Her journey in the transparency and disclosure space first began in 2016 at Eisai where she led the first 3 EMA Policy 0070 submissions and the coordination of activities for plain language summary development, the release of patient-level data to qualified external researchers, along with new and upcoming health authority requirements. Devaki also had exposure to governmental sector data sharing in identifying and implementing process improvements during the critical transitionary period of organisational change for the UK’s public health reform initiative and she has an understanding of multiple areas in the pharmaceutical and healthcare industry through her previous roles, including Medical Information and Drug Safety. As part of the response to the global pandemic, Devaki contributed to the transparency project for one of the leading COVID-19 vaccines to receive approval, providing guidance to the marketing authorisation holder on the operational elements for EMA and Health Canada’s request for publication of the full clinical data used to support their authorisations of this vaccine. | Muhammad Oneeb Rehman Mian: Working Group Lead
Muhammad Oneeb Rehman Mian is a Senior Manager of Privacy & Data Enablement for the Clinical Trials Transparency (CTT) business stream at Privacy Analytics. He provides technical leadership and subject-matter expertise for privacy methodology and solutions. Muhammad has over 4 years of experience developing scalable risk-based anonymization technologies for clinical trials data, evolving privacy threat modelling and identifiability metrics, and exploring solutions to practical challenges faced in the field of privacy and data protection engineering. Previously, Muhammad worked in biomedical research, applying statistics and Big Data analytics to solve novel problems. Muhammad draws from his prior experience in medical research to enable privacy programs that ensure data is useful and accurate. |
