Patients Should Inform Clinical Trial Development: Inspire Webinar 1 2020

Patients Should Inform Clinical Trial Development: Inspire Webinar 1 2020 By Jeff Terkowitz Lesley Gosden, a patient and patient advocate with Parkinson's disease, gave the patient keynote speech opening “Patients As Partners Europe,” held January 27-28.1 She described her experience in the GDNF study, which involved the surgical implantation of a port for infusions of GDNF directly into the brain of Parkinson’s patients, bypassing the blood-brain barrier. Ms. Gosden is one of those who experienced an enormous benefit from the GDNF: prior to her involvement in the trial, she was wheelchair bound. Afterwards, she could walk again. [...]

Real World Data to Real World Evidence

Real World Data to Real World Evidence By Kathleen Hoffman, PhD MSPH You’ve started a medication, and you feel “off” in some way. How “off” do you have to feel before you mention it to your doctor or until you or she sends an Adverse Drug Reaction (ADR) report to the FDA through the MedWatch program? On the other hand, how “off” do you have to feel before mentioning it to your peers in an online health community? A study conducted by Inspire and Stanford University found that people mentioned an ADR for a specific drug [...]

Are You Listening to Patients? Patient Preferences and Clinical Trial Design

Are You Listening to Patients? Patient Preferences and Clinical Trial Design By Kathleen Hoffman, PhD, MSPH Last fall, over 1500 Inspire members living with sarcoidosis, scleroderma, ovarian cancer, prostate cancer, colorectal cancer, arthritis and psoriasis, completed a  survey on exploring patient preferences and insights on clinical trials. Our recent webinar, "A Hopeful Mindset," described preliminary results. Thirty-nine percent of respondents had cancer, 32% had a chronic condition - arthritis or psoriasis - and 29% had a rare disease. Over the next few months we will be sharing more details from the data.  Last week in "5 Benefits [...]

5 Benefits of Patient Focused Drug Development Sponsors Need to Know

The Patient Is Speaking: 5 Benefits of Patient Focused Drug Development Sponsors and CROs Need to Know By Sara Ray, MA Since the 2012 FDASIA reauthorization of the Prescription Drug User Fee Act (PDUFA) and the 21st Century Cures Act ‐‐ Directing and Enabling Patient Focused Drug Development in 2016, integrating the patient perspective has been a priority. Our research team has conducted studies with patient and caregiver Inspire members for a variety of sponsors. I'd like to describe how these research projects produce important patient insights that inform and can improve clinical trials. Patient focused drug [...]

A Hopeful Mindset: Patient Insights on Clinical Trials Webinar

A Hopeful Mindset: Patient Insights on Clinical Trials Webinar By Kathleen Hoffman, PhD, MSPH In November 2018, Inspire sent a clinical trial perceptions research survey to caregiver and patient members with the following conditions: ovarian, colorectal and prostate cancer; scleroderma and sarcoidosis; and psoriasis and arthritis. Over 1600 respondents completed instrument. Members were asked, “If you were eligible for a clinical trial, how interested would you be in participating?” One "very interested" member explained, “Scleroderma is a rare autoimmune disease which has no cure, so any research would help the future.” Another stated, “I have advanced cardiac [...]

What Matters Most to People Impacted by Rare Disease: An Inspire-FDA Collaboration

What Matters Most to People Impacted by Rare Disease: An Inspire-FDA Collaboration By Sara Ray What happened when we compared research strategies used to obtain patient insights? We discovered that using multiple strategies is key to gaining usable understandings. In a recent collaboration between Inspire and the FDA, we compared and contrasted patient and caregiver generated online communication with the results of one of FDA’s Voice of the Patient meetings. The Data Sets Inspire’s membership includes over 350,000 patients and caregivers living and coping with rare diseases. In the last three years, there has been 203% growth [...]

Can social media help uncover insights about the patient journey?

Can social media help uncover insights about the patient journey? By Monica St Claire Does patients’ social media content truly reflect the real world experience of patients in general? Can it uncover insights about the patient journey? This question tends to come up when someone is new to this type of research. It’s a good question. Social media’s pervasive presence has been documented by Pew Research, among others, finding that Facebook is used by 74% of Americans on a daily basis, over half saying it is used more than once-a-day, and that 73% of Americans use multiple [...]