What if we could reimagine patient safety? How might we communicate a drug’s benefit-risk profile to patients and HCPs more effectively? And how can we make sense of the terabytes of safety data being generated, in a really useful way? A co-creation session we held with the heads of safety of GSK, Ipsen, Lilly, Merck KgAa, Novartis, Pfizer, Roche, and UCB identified a range of compelling solutions, three of which are showcased below. Much more detail and more of the new ideas we discussed will be part of an upcoming paper on the Future of Safety which we will be released this summer.

Identifying the human problems

We started by looking at what are the human problems that currently exist throughout the product lifecycle, and where PV might have the power to help solve? From development to launch to post-marketing, each group of stakeholders has their own unique questions and concerns related to safety outcomes: patients, scientists, regulators, HCPs, the C-suite, safety professionals, and many others.

For instance, at the development phase, patients may have questions about how to understand the risks and benefits of participating in clinical trials, and may wonder if they should really get involved in the trial, and what the appropriate expectations are for their own health outcomes.

During the launch, regulators may ask whether they are right to be worried about this new drug product? It’s going from a very controlled clinical trial environment into a much wider population. Can I trust that the company is doing what’s right for patients?

Or during post-marketing, a Head of Safety may ask “How can I keep quality and compliance on track, and deal with all these CAPAs? With the increasing volumes of adverse events, how can we manage this proactively with a fixed or shrinking budget?”

Three ideas

Our group of safety leaders discussed a range of solutions to solve for the human problems identified. Here are three of them:

(1) introducing treatment contracts: this would be an agreement between the pharma company and the patient (and HCPs), which clearly sets out the expectations of the relationship both during the trial and beyond. The contract could be governed by a third party and would explain the process and terms for gathering data, and the value of the trial for long-term learning about the disease. A focus on disease management rather than a cure would help patients make an informed decision about their options. Outcome-based reimbursement could also be made part of a treatment contract.

(2) Another way to better inform patients about safety information would be through human-centric Patient Information Leaflets (PILs) that effectively tell a relatable story, using tools like animation and infographics to help patients understand and absorb what they are reading. We could rethink how and when and where patients receive this essential information, and go digital with the format to make it more accessible. Informed consent forms could be improved in the same types of ways.

(3) Our discussion also looked at the overall structure of PV and asked, what if we zero-based pharmacovigilance? What if we could redesign the entire industry PV ecosystem from the ground up, focusing on the real needs in today’s world? We could put the patient at the center and utilize the flow of safety data to inform real-life benefit and risk. We would challenge the orthodoxies of the old system and open the doors to disruptive change and divergent thinking. We would seek out better data, not more data, and process that data once but use it many more times. With a different perspective and processes in place, PV could become a source of value to a company, and not just a cost.

Moving towards the future

To us, these are the kinds of ideas that will inspire the next generation of leadership in PV. Yes, there will always be organizational blockers and barriers in place that see the way things are done now as the way they must be, but we see the huge advances in data and connectivity and information flows as creating new capabilities for disruption that can be the basis for a new and more collaborative Future of Safety. Stay tuned for more details in a few months, as we launch the paper and invite you to join the discussion.

Julika Erfurt

Senior Manager - Life Sciences

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