Insights on Patient-Focused Drug Development (PFDD) OUR INSIGHTS LEARN MORE Contact Us We share our insights to keep you updated on patient engagement initiatives, trends, and regulatory guidelines Down arrow icon

OUR INSIGHTS

Inform your outcomes strategy by listening to the trial patients
Laura Lassen
Posted by Laura Lassen
November 6, 2020

Can you set a strong outcomes strategy without listening to the patients?

Interviewing patients can help you in choosing the most relevant patient-reported outcome measures to apply in your clinical trials. Patient-reported outcome measures (PROMs) are frequently applied…

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Get to know what the users think about your investigational drug
Laura Lassen
Posted by Laura Lassen
October 30, 2020

Can you set a strong marketing strategy without hearing what users think about your investigational drug?

Get a clearer picture of your investigational drug prior to market launch. Interestingly, the pharmaceutical industry has remained one of the few industries where direct user feedback is not…

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Collaboration to reinforce patient relevance in evidence generation
Laura Lassen
Posted by Laura Lassen
October 23, 2020

EMA wants to strengthen the collaboration with HTAs to reinforce patient relevance in evidence generation

Highlights on EMA’s focus to advance patient-centred access to medicines in partnership with healthcare systems. In EMA’s Regulatory Science Strategy to 2025, the EMA presents...

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Patient-centred drug development in EMA's Regulatory Science Strategy to 2025
Laura Lassen
Posted by Laura Lassen
October 16, 2020

Patient-centred drug development in EMA's Regulatory Science Strategy to 2025

Increased interest from EMA to enhance the incorporation of patients’ voices into drug development. As part of the EMA’s Regulatory Science Strategy to 2025, EMA proposes…

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Patient-Focused Drug Development Guidance
Laura Lassen
Posted by Laura Lassen
October 9, 2020

Are you developing drugs in accordance with regulatory guidances on Patient-Focused Drug Development?

The FDA and the EMA are strengthening Patient-Focused Drug Development. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) both acknowledge that…

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Limitations of Patient Reported Outcome Measures (PROMs)
Laura Lassen
Posted by Laura Lassen
October 2, 2020

Why PROMs do not guarantee a full picture of patients’ experiences with new drugs

The limitations of Patient Reported Outcome Measures (PROMs). Traditional PROMs (consisting of closed-end questions) have for many years been applied to reveal the patients’ experiences of effects…

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