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The Next Frontier in Real-World Evidence: Unlocking the Patient Voice
The promise of Real-World Evidence/Data has always been to support clinical decision making with the highest possible quality of evidence. In practice, what does this actually mean and how does it enable us to provide better care for patients? In this article, we share how real-world patient data and the patient voice will become an even more critical part of decision making going forward.
Before diving in, let’s start with some definitions from the Pharmaceutical Advertising Advisory Board (PAAB):
- Real-World Data (RWD): Real world data are data relating to patient status and/or the delivery of health care routinely collected from a variety of sources in real-world settings.
- Real-World Evidence (RWE): Real world evidence is the evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of real-world data.
Some example sources of RWE include:
- Pragmatic trials
- Case control studies
- Cohort studies (prospective and retrospective)
- Data from patient support programs
- RWD from recognized/validated market data providers
We’ve Reached an Inflection Point
2023 was a big year for the Canadian healthcare and life sciences industry. A number of developments indicate a shift taking place as it relates to the use of Real-World Evidence:
- August 18th, 2023 – Canada’s Drug and Health Technology Agency (CADTH) announces the establishment of an industry task force to provide advice on the use of industry-generated real-world data (RWD) in its Post-Market Drug Evaluation (PMDE) Program.
- October 13th, 2023 – PAAB announces that the draft PAAB Guidance on Real-World Evidence/Data has been forwarded to Health Canada for consultation.
- December 1st, 2023 – PAAB announces that the Board has approved the changes to the Code which will come into effect on February 1st, 2024. The updated Code expands the range of RWE findings that are permissible in advertising.
How will these exciting changes impact those that treat and provide life-saving medications to patients? Here are just a few statements that we’ve heard through our network from doctors recently:
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While we can't be sure where the guidelines will land and how they will continue to develop, our hope is that new sources of RWD will make this type of HCP feedback a thing of the past. We expect RWE to play an important role not just in HCP conversations, but in market access decisions, commercial strategy, R&D, and across other functional areas.
The Missing Piece
RWD can be extracted from a variety of sources, including: electronic health records (EHRs), claims data, patient support programs, and disease registries. While these data points are incredibly valuable and help us better understand the patient journey, they miss a critical measure: the patient’s perspective.
The patient voice has been chronically underrepresented in healthcare. It can help us answer key questions like:
- Quality-of-Life (QoL) differences between therapeutic options
- The impact of specific medications on disease control
- What type of role patients play in their own treatment decisions
- What barriers exist in accessing various medications
- Why patients stop taking medications as prescribed
Limitations
Despite the clear value of being able to answer these types of questions, it’s been historically very difficult to capture patient perspectives at scale. Typical mediums for patient feedback (i.e., ad boards, provider conversations, etc.) are plagued by:
- Small sample size - not representative of the population
- Biased - only certain types of patients participate
- Limited reach - only from patients on a single medication
- Static - data collection is done ad hoc and doesn’t allow for monitoring changes over time
Bringing Visibility to the Patient Experience
New sources of RWD will unlock the patient voice in ways we’ve never imagined. What was previously a mystery about how patients experience care, get access to medications, and live with their disease will no longer be. The intersection of this trend with that of an evolving regulatory landscape for RWE creates an opportunity for our industry to come together – doctors, nurses, pharmacists, patient support programs, patient advocacy groups, disease associations, manufacturers - and leverage real-time, real-world data to improve health outcomes for patients.
