protocol design

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 Voice Allows Patients to be Part of the Cure

Real World Voice Allows Patients to be Part of the Cure By Kathleen Hoffman, PhD, MSPH “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, [...]

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 [...]

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 [...]

Rethinking patient engagement in clinical trials: Be part of the solution

Rethinking patient engagement in clinical trials: Be part of the solution By Kathleen D. Hoffman, PhD Seated in the waiting room of a large medical center, I overheard the bright eyed, young man behind the reception desk ask a new patient, “Would you like to learn more about participating in our [...]

How R&D Teams Can Use Patient-Centricity for Clinical Trial Optimization

How R&D Teams Can Use Patient Centricity for Clinical Trial Optimization By Monica St. Claire In 2014, Tufts Center for the Study of Drug Development performed a comprehensive assessment of the use of social media and digital technology in clinical research. This forward-thinking study revealed that pharmaceutical, biotechnology companies and contract [...]