Together Data Scientists set Standards to solve Clinical Trial Data Challenges

Written by Stephen Bamford, PHUSE Founder and Chairman of the Board

We know that sharing clinical trial data furthers our understanding of diseases, expands the base of knowledge needed to develop new treatments and generates more complete evidence to enable providers to make better healthcare decisions for patients. However, data are only valuable if meaningful information can be extracted from them and interpreted in a uniform way. That’s where data scientists can play a vital role – by making sense of clinical data and setting standards for data so that they can be shared collaboratively by industry, academia and government to improve patient outcomes.

That’s why I started @PHUSE (Pharmaceutical Users Software Exchange) more than 15 years ago.  Back in 2004, I noticed that, particularly in Europe, there were no groups or organizations that focused on the data science and programming aspect of clinical trials. What started as a one-time event in Germany for data scientists and analysts to share novel methodologies and research in data sharing has turned into so much more.

Today, PHUSE is a non-profit, volunteer organization with near 10,000 members globally, encompassing the work of data managers, biostatisticians, statistical programmers and eClinical IT professionals across industry, academia and government. We provide an open, transparent and collaborative forum in a non-competitive environment in which academia, regulators, industry, technology providers and others can address computational science needs in support of health product development and regulatory review, ultimately bringing safe and effective medical products to those who need them.

Everything we do is in the pre-competitive space, which encourages otherwise competitors to collaborate. And our standards and platforms are referenced by health regulatory bodies around the world, including the U.S. Food & Drug Administration (FDA), the European Medicines Agency (EMA) and Health Canada.

Currently, we have eight working groups developing innovative solutions that address unmet computational science needs. The Data Transparency group is a team of 50 volunteer experts from around the world solely focused on clinical data sharing and transparency practices. Each expert brings a unique perspective on how to address these challenges. PHUSE brings everyone together in one room to problem solve and ultimately reach a collaborative decision about best practices for how to work together and share de-identified data in a transparent and effective way. The outcome of their work provides the standard in which clinical trial data sharing platforms like Yale Open Data Access (YODA) Project and Vivli operate.

PHUSE is increasingly tapped to use its tools and standards around data, statistical and reporting technologies to address broad regulatory challenges. This is an exciting time as PHUSE becomes known not just for setting the frameworks that guide data use but as the organization that solves the clinical data problems of the world. 

Learn more about PHUSE, join our conferences and help us shape the future of data for good. 


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