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 webinar, “Enhancing Engagement of Communities of Color in Covid-19 Research,” held on January 11 by the Center for Community Health Education Research and Service in Boston. The purpose of this webinar series is to address challenges facing ethnic minorities in accessing healthcare and participating in [...]

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Jan 2021By |0 Comments

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 of clinical trial research. What needs to change?1 The experts were Ray Dorsey, MD, the David M. Levy Professor of Neurology and Director of the Center for Health & Technology at the University of Rochester; Matt Kibby, President and Principal of BBK Worldwide; and Craig [...]

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Aug 2020By |0 Comments

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. [...]

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Feb 2020By |0 Comments

When It Comes to Clinical Trials, Patient Concerns Differ

When It Comes to Clinical Trials, Patient Concerns Differ By Kathleen Hoffman, PhD, MSPH In 2019, Inspire researched patients and caregivers feelings about, and understanding of, clinical trials. Over 1500 members (1644) participated: Members with arthritis, colorectal cancer, prostate cancer, psoriasis, ovarian cancer, sarcoidosis and scleroderma. The findings show that these groups have different understandings of and concerns about clinical trials. Sixteen percent of the participants had already participated in clinical trials. Another 15 percent had tried to participate in a clinical trial but 1) were not eligible, 2) the clinical trial was full or 3) [...]

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Feb 2020By |0 Comments

Using Quantitative and Qualitative Research to Enhance Patient Focused Drug Development

Using Quantitative and Qualitative Research to Enhance Patient Focused Drug Development By Hannah Eccard FDA’s focus of incorporating the patient voice into the drug development process requires the life science industry to engage in new research strategies. Based on what we're seeing so far from the FDA, it appears that the agency is closely considering the value of mixed methods: qualitative research along with quantitative research. Dr. Theresa Mullin, Associate Director for Strategic Initiatives at the Center for Drug Evaluation and Research (CDER) at FDA, said at the first guidance meeting for Patient Focused Drug Development (PFDD) [...]

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Jan 2019By |0 Comments

Over Two-Thirds of Inspire’s Membership Want Clinical Trial Information

Over Two-Thirds of Inspire’s Membership Want Clinical Trial Information By Richard Tsai Recently a member of a rare disease community on Inspire asked fellow members, “What should I know about clinical trials? Are they worth it? Any information would be helpful. Thank you.” Among the replies they received: “Unfortunately, we’ve not had many opportunities to participate in [rare disease] clinical trials. In my opinion, if a pharmaceutical company, medical device developer, etc. has gone through the required steps to get to human trials for [rare disease]--I’d absolutely want to help them by participating!” In another rare [...]

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Sep 2018By |0 Comments

Patient Engagement Leadership Series Part 2: Designing from the Patient Perspective

Patient Engagement Leadership Series Part 2: Designing from the Patient Perspective The patient perspective is based in the lived experience of illness.  Entering into patient-centered or patient informed medication development means understanding that this worldview cannot be provided independently by researchers or clinicians.1 At Sanofi, patient perspectives have been integrated into clinical trials for over seven years and for more than five years in research, according to Victoria DiBiaso, ‎Global Head Clinical Operations Strategy & Collaboration and her colleagues (Amy Ba, Patricia Roselle and Anthony Yanni).  “It’s been a truly transformative approach and has helped us make [...]

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Nov 2017By |0 Comments

Patient Engagement Leadership Series Part 1: Clinical Trial Participants Are Medical Heroes

Patient Engagement Leadership Series Part 1:  Clinical Trial Participants Are Medical Heroes “I think a hero is any person really intent on making this a better place for all people.”  ~ Maya Angelou In Embracing the Patient Centric Culture, I discussed the paradigm shift facing healthcare. “Instead of doing things for or to the patient, now the goal must be empowering and working in partnership with the patient...to elevate the perspectives of patients and caregivers, incorporating their needs and priorities…. Building active listening to, or obtaining a continuous stream of insights from patients and caregivers into [...]

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Nov 2017By |0 Comments