Patient Focused Drug Development PFDD

Menaced by COVID-19, Susceptible Individuals Counter with Vaccine Acceptance

Menaced by COVID-19, Susceptible Individuals Counter with Vaccine Acceptance By Kathleen Hoffman, PhD, MSPH “The sickest I've ever been!" wrote a participant in Inspire’s COVID-19 HealthJourney survey about surviving COVID-19. Another went into greater detail when asked to share their COVID-19 story. I’ve had systemic lupus (SLE) and Discoid Lupus for 25 [...]

COVID-19 vaccines and vulnerable populations: Over 26K participate in ongoing study

COVID-19 vaccine and vulnerable populations: Over 26K participate in ongoing longitudinal study  By Richard Tsai Crowd-sourcing info for a friend: have any of you who have lupus SLE and/or discoid taken the vaccine? Which one? What were your side effects? Thanks for sharing. — Brittney Cooper (@ProfessorCrunk) March 9, 2021 COVID-19 vaccines [...]

Where Do You Start When Searching for Exceptional Responders?

Where Do You Start When Searching for Exceptional Responders? By Richard Tsai Before 2012, if a cancer clinical trial had only one successful remission amid a field of failures, the drug under trial was thought to be unsuccessful. We weren’t asking a key question: What made it work for that one participant? [...]

How Clinical Trial Diversity Saved a Life

How Clinical Trial Diversity Saved a Life By Kathleen Hoffman, PhD, MSPH “My pastor warned me not to participate in a clinical trial,” Karen Barrios said. Going against his advice, Ms. Barrios joined a clinical trial that she believes saved her life.1 Ms. Barrios shared her story as a panelist during the [...]

COVID-19 and a Future with Fundamental Design Shifts: Incorporating Virtual into Clinical Trials

COVID-19 and a Future with Fundamental Design Shifts: Incorporating Virtual into Clinical Trials By Kathleen Hoffman, PhD, MSPH On a recent Pharma Talk Radio podcast called, The Impact of COVID-19 on Clinical Trials: Where are We? And Where are We Going?, three subject matter experts discussed how they see COVID-19 impacting the future [...]

FDA Finalizes First of Four PFDD Industry Guidances

FDA Finalizes First of Four PFDD Industry Guidances By Marina Ness, MA On June 16th, the FDA released the final version of “Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.” This document, referred to as Guidance 1, advises industry on methodologies they can use to collect patient input that will be considered [...]

No “One Size Fits All” Solution to Improve Clinical Trial Participation

No "One Size Fits All"Solution to Improve Clinical Trial Participation By Kathleen Hoffman, PhD, MSPH Clinical trial study designers are trying to find ways to increase participation and reduce dropout. According to three recent studies, the reasons patients give for not participating in clinical trials vary depending on a number of [...]

Where Can I Get This ‘Real World Data’ You Speak Of?

Where Can I Get This ‘Real World Data’ You Speak Of? By Robert Gardner How far has the importance of Real World Evidence advanced as part of treatment development? When the attendees of a recent eyeforpharma webinar were asked, “Are you, or will you soon be using RWE for enabling new [...]

What’s the FDA up to on Patient Focused Drug Development (PFDD) these days?

What’s the FDA up to on Patient-Focused Drug Development (PFDD) these days? By Kathleen Hoffman, PhD MSPH Part of the FDA’s mandate in implementing the “21st Century Cures Act” is ensuring the incorporation of patient experience data into drug development. They’ve hit the deadline for another Patient Focused Drug Development (PFDD) [...]