Industry leaders shift the conversation from “why” to “how”
Imagine that you and a committee of your competitors have been tasked to collaboratively design and build an automobile. You don’t know how it will be used, how many passengers it must transport, or what kind of cargo it will carry. You don’t know what EPA and DOT regulations might exist when your creation rolls off the production line. Got it? Now hit the drawing board and come up with a design that works, wins the public’s trust and forestalls unwanted government involvement.
That’s essentially the assignment set before the life sciences industry in the quest for clinical trial data transparency.
From many of the conversations we’re having, we’re seeing some uncertainty as to what the industry needs to be doing. You need to make clinical trial data available in an easy and inclusive way, but there are many questions still open for debate and consensus.
Finding the questions to ask
What information should be shared, with whom and for what purposes? How much demand is anticipated? How should data access and use be managed? How do you ensure patient privacy without hindering the research value of the data? What should the information delivery and analytics platform look like?
The answers are not challenging from a technical perspective, but for clinical data transparency to succeed, everybody needs to agree on (or concede to) consistent policies and processes – and that’s a work in progress.
“It’s amazing that you have a group of people who all want to do the same thing, but you can’t get them to agree on how to do it,” said a participant at the Clinical Trial Data Transparency Forum we hosted at SAS headquarters in October 2013. Said another: “We go around and around on the same topics and end up with the same unease. Is it just a matter of moving forward with our own individual strategies – or moving forward with a group strategy?”
It’s important for the industry to work together. Sharing and collaboration are critical. That’s why SAS is hosting this multi-part forum. The second installment on February 11 brought together 70 leaders from 28 companies – plus more via webcast.
It’s encouraging to note that conversations are becoming more positive. Conference participants are not talking about whether we should do this; they’re talking about how we can get it right. The recent event focused on the latest news from regulatory fronts, considerations of policy and platform to hammer out, and lessons learned from four pioneers in a joint data-sharing initiative – GlaxoSmithKline, Roche, Sanofi and Boehringer Ingelheim.
Agreed-upon fundamental requirements
From the presentations, Q&A and breakout sessions of the day, we heard agreement on the fundamental requirements of a successful clinical trial data transparency initiative:
- Public access to a library of available studies, coupled with a consistent, user-friendly and auditable online data request process.
- An independent review panel process to review research proposals and grant or deny data access based on agreed-upon criteria that may be specific to each sponsor and study type.
- A scalable, secure computing environment with advanced analytics built in, where researchers can create, run and save their own analyses using multiple tools.
- Access to patient-level data, de-identified as appropriate for the research at-hand and protected from possible re-identification.
- Protection of data from uncontrolled distribution or misuse – restricting data sharing across research projects or exports of raw data from the shared computing environment.
- The ability for multiple researchers to securely collaborate on a project, and for a project to analyze data from multiple sponsors in the same environment.
Inaction is not an option, unless the industry will be content with a framework imposed by others. The better option is to press forward even if the path is unclear.
“Data sharing in a multi-sponsor environment is new, so the more we do it, the more we’ll learn and ease concerns,” said a conference participant. “We need to continue to sell “the why” as we figure out “the how.” Remember, Martin Luther King didn’t have a plan, he had a dream.”
Forum attendees represented: AbbVie, Amgen, Astellas, AstraZeneca, Bayer Pharma AG, Boehringer Ingelheim, Celgene, EIi Lilly & Company, F. Hoffmann-La Roche AG, Forest Laboratories, Gilead Sciences, GlaxoSmithKline, ideaPoint Inc., Janssen R&D, Johnson & Johnson, MedImmune, Merck & Company, Novartis, Novo Nordisk, Otsuka Pharmaceutical, Paarlberg & Associates, Pfizer, Roche, Sanofi, Shire Inc., SAS, Takeda Development Center Americas, UCB Biosciences and ViiV Healthcare. Comments in this article represent a compendium of general discussion at the forum and not the opinion of any particular organization.