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

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...

Read More
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…

Read More
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…

Read More
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…

Read More
Hearing patients' experiences in clinical trials
Laura Lassen
Posted by Laura Lassen
September 25, 2020

Can you afford to launch a new drug without hearing what patients think about it?

Get the full picture of a treatment. To ensure that you get a clearer picture of a treatment, we recommend interviewing the users who are exposed to a drug candidate as early as possible in the trial…

Read More
Clinigma Patient Interview Portal
Laura Lassen
Posted by Laura Lassen
September 4, 2020

Introducing the Clinigma® Portal

An IT portal facilitating secure and easy collection of trial patient feedback. Patient insights and experiences are critical for pharmaceutical companies to successfully bring new drugs to market…

Read More