Patients Enroll In Studies When They Have a Voice: Real World Study Succeeds with Patient Voice

Patients Enroll In Studies When They Have a Voice: Real World Study Succeeds with Patient Voice By Kathleen Hoffman, PhD, MSPH The most persistent hurdle in running a clinical trial is recruiting and keeping participants. More recently, the FDA added the expectation that the value of released drugs be supported with Real World Evidence (RWE). A recently-conducted multi-center prospective observational study accomplished both by using patients as partners throughout clinical design. The PROP-UP study was a designed to collect real world patient centered data on the harms and benefits of the new, highly effective, direct-acting antiviral [...]

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May 2020By |0 Comments

Real World Voice Allows Patients to be Part of the Cure

Real World Voice Allows Patients to be Part of the Cure By Claire Harter “The patient wants to be a partner in cure, just as with their doctors they want to be a partner in care.” - John Linnell, COPD Patient Advocate, talking about health literacy, eyeforpharma virtual conference, 4/14/2020 Where and how can patients partner with pharma for a cure? Where can pharma go to learn from patients about the patient experience? One resource is Electronic health records (EHRs). As a resource, they provide critical information about patient diagnosis and treatment. But, EHRs reflect the [...]

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Apr 2020By |0 Comments

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 factors including the condition being studied, the gender or age of participants, and even minority status. Accommodating these differing needs in the study design would support enrollment and sustain participation, but it requires asking prospective participants what would lower the barriers for their specific condition [...]

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Jan 2020By |0 Comments

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 types of value or outcomes-based assessment within your own firm?” 35 percent responded that they already consider RWE “a universal and necessary standard,” with another 26 percent saying RWE is or will be used as evidence in developing “specialty and high-priced treatments.” A “universal and [...]

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Dec 2019By |0 Comments

Patient Centricity: Joining Qualitative with Quantitative

Patient Centricity: Joining the Qualitative with the Quantitative By Kathleen Hoffman, PhD, MSPH Reams of market research and data can provide insight, but so can one patient in the room, telling you what really matters to them.1~Paul Tunnah, PharmaPhorum founder The FDA’s drug approval process requires developers to submit quantitative data demonstrating that the treatment is safe and effective after testing in a representative target population. But if you’re accustomed to using quantitative studies to attain approval, you might be feeling jaded about patient centricity guidances. As Tunna’s article says, “...everyone seems keener to shout about [...]

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Dec 2019By |0 Comments