What’s the FDA up to on Patient Focused Drug Development (PFDD) these days?

What’s the FDA up to on Patient-Focused Drug Development (PFDD) these days? By Kathleen Hoffman, PhD MSPH Part of the FDA’s mandate in implementing the “21st Century Cures Act” is ensuring the incorporation of patient experience data into drug development. They’ve hit the deadline for another Patient Focused Drug Development (PFDD) Guidance document, so let’s look at the status. Background The Agency is in the process of issuing four PFDD guidance documents to “address, in a stepwise manner, how stakeholders can collect and submit patient experience data” for medical product development and regulatory decision-making.1 Draft Guidance [...]

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Sep 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 [...]

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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 [...]

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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 [...]

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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 [...]

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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) [...]

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Jan 2019By |0 Comments

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 [...]

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Nov 2018By |0 Comments

Federal Agency Perspectives on Clinical Trial Eligibility: Spring 2018

Federal Agency Perspectives on Clinical Trial Eligibility: Spring 2018 “Most current [breast cancer] clinical trials only enroll what I call the metastatic cancer ‘Olympians:’ the healthiest of the dying, those who are on their first or second line of therapy, who have limited metastases, who don't have brain mets, who don't have other diseases like diabetes or high blood pressure,” Dr. Kelly Shanahan, an obstetrician-gynecologist, activist, consumer reviewer for the Department of Defense Cancer Research Program and patient with stage 4 breast cancer said in an interview via email.1 Dr. Shanahan’s description matches many of the concerns [...]

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May 2018By |0 Comments

Inspire posts forward medical research in adverse drug reactions, new study shows

Inspire posts forward medical research in adverse drug reactions, new study shows Over 2 million injuries, hospitalizations and deaths in the US each year are associated with post-approval adverse drug reactions (ADRs).1 The usual method of gathering ADR data is through provider reporting.  Research suggests that health care providers tend to under-report ADRs, sometimes because patients just don’t discuss all of their treatment experiences with them.2 Supplementing spontaneous provider-reliant reporting could be extremely beneficial to patient safety. In Can Patient-Generated Health Communication on the Internet Enhance Pharmacovigilance? (Part 1)3 and Research Confirms: Valuable Patient-Centered Data on Inspire [...]

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Mar 2018By |0 Comments