Data Transparency

Working Group Scope

Active since 2014 the Data Transparency Working Group is made up of more than 70 active members from pharmaceuticals, CRO’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 de-identification standard’). Since then, the 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 Group also reviews, on a regular basis, draft deliverables, or guidance documents from regulatory bodies (e.g. the EMA, Health Canada), as well as other industry organisations such as TransCelerate, and academia (e.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.

Current Projects

Anonymization of Imaging Data

Educate the General Population on Data Privacy and Data Sharing

EU CTR Implementation

Good Transparency Practices

Internal Clinical Study Data Sharing Process

Rare Disease/Small Population Data Sharing

Resources

Click here to search for all Data Transparency deliverables, past projects are housed under the archived section.

jean-marc.ferran@phuse.global

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@phuse.global

Stephen is the Head of Clinical Data Standards & Transparency at the Janssen Pharmaceutical Companies of Johnson & Johnson. Stephen has been a member of the Johnson & Johnson 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 organisations.

In 2004, Stephen founded the PHUSE organisation. 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.

devaki.thavarajah@phuse.global

Devaki has almost 10 years’ experience working with pharmaceutical, research and healthcare communities globally to help meet their clinical trial transparency and disclosure requirements. Devaki also identified and implemented process improvements for the UK government sector during the critical transitionary period of organisational change in the public health reform initiative. 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.

mrehman@privacy-analytics.com

As an Associate Director of R&D Solutions, Muhammad Oneeb Rehman Mian empowers clients to unlock the vast potential of clinical trial data for secondary analytics and to enable transparency initiatives. He specialises in cutting-edge privacy-enhancing technologies (PETs) and tooling. He has more than five years of experience in developing scalable AI-enabled anonymisation technologies, evolving privacy threat modelling and identifiable metrics, and providing solutions to practical privacy challenges. Muhammad is regularly involved in thought leadership and standards development.