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Why market access and evidence-generation needs to amplify the patient voice


In this excerpt from our article, “Integrated Evidence Generation 2.0: a strategy for every stakeholder”, we explore the evolving role of the patient voice in market access, and the vital role of patients in evidence-generation.

Considering the patient voice early on within your evidence-generation process

The patient voice is becoming an essential part of the evidence-generation process. Understanding what is important to patients, their experience, journey, the burden of illness, and their unmet needs is not only important from a patient perspective, it also feeds into what biopharmaceutical companies need to communicate to clinicians and payers as well. There are many benefits to considering the patients early on; doing so is not only more advantageous to the patient outcome, but if the patient insight is left until too late in the process, there is no time to build it into product development.


Increasingly, patients are playing more of a role in shared decision-making and providing their perspective on the value of new treatments, sharing insights that feed into the HTA process. It is therefore important to consider these stakeholders’ needs early in the product development cycle—before committing to pivotal or registration trials.

Samara Ferguson

Executive Director

avatar for Samara Ferguson - Executive Director


Today, 10 European Union member states have a mechanism for patient engagement in their health technology assessments (HTAs) emphasizing the importance of patient input at the advice and decision-making stage. (Amin P, et al.)

Patient-reported outcomes are a powerful tool that can be used to inform regulatory approval and can be collected during clinical trials or as real-world evidence (RWE). The measures help determine patients’ quality of life, current health, side effects, symptoms, and well-being, offering a direct window into the patient experience. Key considerations when developing patient-reported outcome measures include engaging patients early and ensuring validity, reliability, and standardization of the data, along with remaining sensitive to changes over time.

Patients and patient advocacy groups should therefore be included at every step. It is important to ensure the process is free from barriers for the patient and healthcare professional. This should include a particular emphasis on overcoming challenges for underserved groups who may find completing the data collection particularly difficult (e.g, those with learning disabilities). (Calvert MJ, et al.).


Integrated Evidence Generation 2.0: a strategy for every stakeholder

This excerpt was taken from the free market access article “Integrated Evidence Generation 2.0: a strategy for every stakeholder”. The full article explains why innovative biopharmaceutical manufacturers are thinking beyond the regulators to take a holistic approach to evidence generation that meets the needs of a variety of stakeholders.

Download the article now to learn more about new strategies for evidence generation within market access.

  • Gain insight into developing a multistakeholder approach to evidence strategy that provides a holistic understanding of the product value and maximizes return on investment.
  • Understand how to focus your teams on the evidence that matters most to each external stakeholder.
  • Discover how patient-reported outcomes, collected during clinical trials or as RWE, can be used as a powerful tool to inform regulatory approval.

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