PHASTAR Life Science Summit

Sally Hollis Memorial Lecture

A Decade (nearly) of Data Sharing

Rebecca Sudlow, Global Lead, Patient Level Data Sharing, Roche

13:30 - 14:30 (BST)31st May 2022

Annual Sally Hollis Memorial Lecture

The Sally Hollis Lecture was established in 2021 in memory of Professor Sally Hollis, a much-loved and highly respected member of the PHASTAR team. Sally was a highly talented leader whose contribution was recognised as outstanding by all who worked with her.

Each year a Sally Hollis Lecturer is chosen in recognition of outstanding contributions to the field of medical statistics. The Lecturer alternates each year between academia and industry to represent the substantial cross-discipline impact that Sally had.

Professor Sally Hollis started her career at Hope Hospital in Salford, where she established long-term research partnerships resulting in many co-authored papers and contributed to the setup of a national audit of the quality of diabetes care. In 1995 Sally joined Lancaster University as one of three founder members of the Medical Statistics Unit within the Department of Mathematics and Statistics, progressing to the position of Senior Lecturer.

Sally's knowledge of the NHS and wide-ranging experience of clinical research projects were critical to the unit’s collaborative work at the academic/non-academic interface. Sally played a major role in setting up the MSc in Medical Statistics at Lancaster University, which was the first of the Department of Mathematics and Statistics’ set of master’s programmes. During her 9 years at Lancaster University, Sally was also instrumental in the formation of a North West NHS research support unit, taking responsibility for all training and consultancy services in Lancashire and Cumbria, and she established and directed a North West programme of training for healthcare professionals in critical appraisal of research evidence. She was also statistical editor of the Cochrane Skin Group, Annals of Clinical Biochemistry and Diabetic Medicine. Sally left Lancaster in 2004 when she was head-hunted to a post in the pharmaceutical industry, at AstraZeneca’s Alderley Edge site. At AstraZeneca, Sally held numerous statistical leadership roles in drug development, across phase II and III, and lifecycle management.

In 2014, Sally was appointed Honorary Professor of Clinical Trials at the University of Manchester. She also joined PHASTAR in 2016 as the Head of Statistical Consulting, where her responsibilities included providing technical leadership to PHASTAR’s statistical consultants, co-ordinating knowledge sharing, and leading statistical research efforts, in addition to providing consultancy to clients.

About the talk

2013 was a pivotal year in the data sharing landscape with the publication of the EFPIA/PhRMA “Principles for responsible clinical trial data sharing” (ref) and the announcement of EMA Policy 70. This presentation will reflect on the progress to date for data sharing. Has the data transparency movement fulfilled its promise? What have we learnt along the way? Where next?

About Rebecca

Rebecca Sudlow has worked in the pharmaceutical industry for over thirty years. Rebecca worked as a clinical trial statistician where she designed and analysed clinical trials across all phases of Clinical Drug Development and across a variety of disease areas including Virology, Rheumatoid Arthritis and Oncology. She has managed statistical teams and represented statistical strategy at health authority meetings and advisory committees. Rebecca started her career at ICI Pharmaceuticals (now AstraZeneca) and moved to Roche in 1996.

Since 2013, Rebecca has been involved in data transparency, particularly with regard to enabling access to patient level datasets from clinical trials. She was part of the Roche team who worked very closely with GSK to develop the cross-company patient level data sharing platform “clinicalstudydatarequest.com” which launched 01 Jan 2014. Data sharing is now Rebecca’s full time focus and her global team enable the responsible reuse (both internal and external) of patient level data to accelerate the generation of insights to further our understating of diseases and treatments.

Rebecca is a member of the cross company EFSPI/PSI Data Transparency Special Interest Group (SIG) and was co-lead 2016-2021. The SIG has representation from across pharma and academia and their objectives include:

1. Promote an understanding of the challenges and responsibility organisations and statisticians have when re-using or sharing clinical data.
2. Improve understanding, implementation and examples of anonymisation methodologies within the context of clinical trial data sharing.
3. Influence and shape the environment and policies regarding clinical data sharing.
4. Collaborate with other groups and stakeholders in this area.

Rebecca has a BSc in Applied Statistics and an MSc in Statistics.

Missed last year's event? Watch recorded presentations in our Knowledge Center