Respecting privacy matters

Respecting privacy matters By Kathleen Hoffman, PhD, MSPH In May, the HealthcareNOW radio program “Harlow on Healthcare” featured Inspire’s founder and CEO, Brian Loew speaking with David Harlow, host and health care law consultant. In the interview, Loew describes Inspire’s patient and caregiver members as a “rich and largely underutilized sources of expertise” about disease conditions and treatments, including medications. Access to this wealth of information requires profound respect for those owning it. “The Inspire community was created to meet the need people have to find information about their conditions from other people living with the [...]

Read More

Jun 2019By |0 Comments

Genetic testing: What patients and caregivers understand and value

Genetic testing: What patients and caregivers understand and value By Richard Tsai There’s been an explosion of information about genes, genetics and genomics since completion of the Human Genome Project in April 2003. Stories about remissions achieved through pharmacogenomics and immunotherapy and disease risk factors identified through genetic testing fill both online and offline media. Today, direct-to-consumer (DTC) genetic testing companies--which make kits available at between $100 and $200-- have huge databases of genetic information. In fact, even if you have never used a kit, you may be able to be identified through these databases if [...]

Read More

Jun 2019By |0 Comments

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 [...]

Read More

Jun 2019By |0 Comments

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 [...]

Read More

May 2019By |0 Comments

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 [...]

Read More

May 2019By |0 Comments

Wearable Devices Revolutionize Clinical Trials… But when?

Wearable Devices Revolutionize Clinical Trials...But when? By Richard Tsai Here is the vision: Wearable devices open the floodgates to clinical trial participation. Patient-centric and portable, they’ll free the participants from multiple visits to the clinical site. Technology collects millions of data points per user per day, and then transmits it directly to researchers. High participation and rich real-world data and evidence (RWD/RWE) streamline clinical trials, satisfy 21st Century Cures Act requirements, and yield what everyone wants – a faster track to drug approval. 1 That time is coming – the Apple Watch 4 won FDA approval as [...]

Read More

May 2019By |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) [...]

Read More

Jan 2019By |0 Comments

Video Vignettes: Through Their Own Eyes: Rare Autoimmune Liver Diseases

Video Vignettes: Through Their Own Eyes: Rare Autoimmune Liver Diseases By Kathleen Hoffman, PhD, MSPH The liver has been called a forgiving organ because of its capacity to regenerate. However, chronic unrelenting damage over years can overwhelm its regenerative abilities, resulting in permanent scarring. Well-known risk factors-being overweight, alcohol abuse, viral infections like Hepatits-C--make cirrhosis of the liver the seventh leading cause of death in the US, affecting an estimated 1 in 400 adults. 1 Yet, a small number of cirrhosis cases are caused by three rare autoimmune diseases,  autoimmune hepatitis (AIH), primary biliary cholangitis (PBC) and [...]

Read More

Jan 2019By |1 Comment

How You Can Achieve Patient Focused Drug Development

How You Can Achieve Patient Focused Drug Development By Monica St Claire The application of a sociolinguistic lens can glean hidden meanings within seemingly ordinary communications. On the Society of Linguists website, Walt Wolfram, director of the North Carolina Language and Life Project at North Carolina State University said, “We use language to send vital social messages about who we are, where we come from, and who we associate with.” Wolfram says that we can learn much about a person just by their choice of a single word.1 In the area of health communication, linguists identify [...]

Read More

Nov 2018By |0 Comments