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 [...]

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 [...]

Customer Loyalty and Service Insights for the Pharmaceutical Industry

Customer Loyalty and Service Insights for the Pharmaceutical Industry By Dana Deighton “Only nine percent of U.S. consumers believe pharmaceutical and biotechnology companies put patients over profits.” This sentiment, found in the 2016 Harris Poll of Reputation Equity and Risk Across the Health Care Sector, has stayed fairly consistent in Harris polls until recently.1 In this year’s April and May series of surveys around the COVID-19 pandemic, Harris asked the question, “How has your view of [the Pharmaceutical Industry] changed since the start of the coronavirus pandemic?” In both the polls, 40% of respondents had a more [...]

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 [...]

On being a medical hero in the era of social media: Discussing clinical trial participation online

On being a medical hero in the era of social media: Discussing clinical trial participation online By Kathleen Hoffman, PhD “Garrett’s Hero Run” is not the name of a New York Times Bestseller or an up-and-coming blockbuster movie - though it could be. At the moment, it’s the name of a series of races held every year in a small town in Tennessee. A fundraiser name that is poignantly metaphorical. Everyone comes dressed as their favorite superhero and they run the races. But the name is also emblematic of urgency because this is a race against a [...]

Find Your SMART: A blueprint for patient engagement

Find Your SMART: A blueprint for patient engagement The drug development process has historically siloed pharmaceutical companies and patients until the time comes for clinical trials. Drug development is a complex, expensive process that requires a lot of expertise. But patients are experts on their own experience of illness and their insights should be more integral to drug development. The pharmaceutical industry is already on the path towards integrating the patient experience early and often in the drug development process, partly because of the 21st Century Cures Act, which was made law in 2016 [my colleague Jeff [...]