Highlights from the fourth SAS Clinical Trial Data Transparency Forum
“Access to the underlying (patient level) data that are collected in clinical trials provides opportunities to conduct further research that can help advance medical science or improve patient care. This helps ensure the data provided by research participants are used to maximum effect in the creation of knowledge and understanding.”
That’s the word from ClinicalStudyDataRequest.com, the data sharing consortium that represents the founding sponsor, GlaxoSmithKline and now nine other sponsors.
Sharing patient-level data for altruism and good? The ideal was not initially embraced.
“When I think back two years to when GSK first started talking about this, there was certainly some concern among staff,” said Paul McSorley of GlaxoSmithKline, a pioneer in the data-sharing movement. “’How much work is this going to be? What happens if or when researchers reach different conclusions from our own?’ We’re way past that now. GSK scientists recognize that these concerns, while real, can be mitigated – and because there is so much support for the potential value data sharing can bring to the medical community, we are very proud of what GSK is doing here.”
In the year since we hosted the first Clinical Trial Data Transparency Forum, we’ve seen a notable shift in organizational culture and the tenor of the discussions:
- Stage 1. “We see merit in the idea, but we also see many ways it could go wrong.”
- Stage 2. “We need to do something before external entities impose a data-sharing framework on us.”
- Stage 3. “We’re excited to be at the forefront of creating policies and processes to make this work.”
- Stage 4. “This may not be the final state of things, but here’s what has been working for us.”
The fourth forum, held at SAS in Cary, NC, on October 2, exemplified stages 3 and 4 – endorsement for data sharing, and more tangible progress to show for it. These events are not SAS infomercials, far from it. Our role is to facilitate – to join and formalize the conversations that have been taking place in various corners of the industry and academia. As my co-host Matt Gross quipped, SAS provides the room and the food for people to come together. The participants provide the expertise, passion and collaborative spirit.
To start the day, we heard from Dr. Ronald Krall, MD, of the University of Pittsburgh (formerly Chief Medical Officer for GlaxoSmithKline) about the why and how. He challenged the audience to think about what’s next. What’s easily achievable, what’s more aspirational? How can we bake data sharing into the clinical trial process?
As Krall noted, you might be afraid that secondary research reveals something you didn’t want to know, or something that could harm your product or competitive position, but if you’re committed to knowing everything you can possibly know about your products – and you’d rather know it sooner than later – transparency is the ticket.
Dr. Eric Peterson, MD, of the Duke Clinical Research Institute outlined the rigorous, pragmatic framework his group has adopted for review of research requests and publication of associated findings – a model for commercial organizations to consider as well.
Marla Jo Brickman, PhD, of Pfizer and Judy Bryson, PharmD, of UCB Biosciences, Inc., described what it looks like to be an early adopter with a foundation in place and traction building. Both firms were committed to transparency before; what’s new is the more structured way it is done now.
Dr. Kald Abdallah, MD, PhD, Chief Project Data Sphere Officer, and Mark Lim of FasterCures reminded us of the value of data-sharing consortia. The questions are too complex for any of us to answer alone, but they might be answered by triangulating insights in many different places.
Places such as the Yale Open Data Access (YODA) Project. Karla Childers of Johnson & Johnson – which earlier this year announced its participation in YODA – described the process used to review data requests, which will make the data-sharing process independent yet collaborative.
Assuming the data are available and can be de-identified to preserve patient privacy, what is a reasonable request? What is the ideal? Our panelists agreed that shared data shouldn’t be used only to question the validity of previous primary research. The risk there is that by changing parameters and analytical techniques, it is possible to come up with contrary but specious conclusions – and the real value of secondary research is found in creating new knowledge.
This concern about poor analysis can be mitigated by carefully vetting requests – and it might not be that much of a concern to begin with. Ben Rotz of Eli Lilly noted that few research proposals seek to replicate previous research; the overwhelming number are quests to create new science. McSorley concurred, noting that only 1 of 23 research proposals received was intended to confirm results from a previous GSK study.
Momentum is building. Take ClinicalStudyDataRequest.com for example. Initiated by GSK, the online portal now includes 10 sponsors – Bayer, Boehringer Ingelheim, GSK, Lilly, Novartis, Roche, Sanofi, Takeda, UCB and ViiV Healthcare. The site receives an average of 900 visitors a day, 219,000 unique visitors in the last 18 months, reported Dr. Jessica Scott, MD, JD, of GSK.
Clearly we are moving away from “how do we think this could work” to “how is it working” and “how can we improve this as we move forward?”
“We’ve overcome some of the cultural lock-in, the inertia in industry over the past couple of years since we’ve started this process – and have gone from commitments to implementing a system that’s actually up and running and working,” said Scott.
In fact, it has moved from concept to reality very rapidly. We’re beyond infancy in some areas, now evolving from small pilots to a sustainable model, applying early lessons to scale, respond to feedback, and accommodate the needs of the broader industry and the goals we all share.
“When people sign up to be subjects in an experiment, they make a tremendous sacrifice on society’s behalf,” said Krall. “Our responsibility is to make sure that sacrifice gets the best possible use. If the data can make a contribution – even if it’s a use not envisioned until years later – we have an obligation to make that possible.”
McSorley agreed: “Part of the mindset change is that it’s not our data, it’s data that belongs to the larger medical community.”
Dr. Stephen Freedland, MD, of Duke University School of Medicine channeled his inner JFK to remind us of the bigger picture: “Ask not what are the risks of data sharing, but what are the risks of not sharing data.”
OnDemand recordings of all the presentations from the fourth Clinical Trial Data Transparency Forum are available for viewing.