Getting the Most from Clinical Trial Protocol Feasibility Studies

Getting the Most from Clinical Trial Protocol Feasibility Studies By Monica St Claire Webinar provides expert tips for getting real feasibility data, optimizing trial design When the drug development process is at the point of moving to clinical trial, the next step is conducting a feasibility study. Stakeholders are all looking to hit the jackpot: figuring out the best place to conduct the clinical study, and identifying the design factors that result in maximum patient retention. Recently, the topic of the WCG Institute’s podcast “Stump the Experts” was feasibility. It featured Diane Carozza and Danya Kaye, [...]

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Nov 2019By |0 Comments

Do You Really Know How Patients Talk About Their Condition?

Do You Really Know How Patients Talk About Their Condition? By Kathleen Hoffman, PhD MSPH There are classic examples of advertising messages that ended up offending the target customer, but the Utah Department of Transportation provided the most recent. The Utah DOT’s lighthearted attempt to adopt a specific culture’s way of speaking was predictably ridiculed when “Hey Teens, Buckling Up is Totes Yeet Yo” (meaning “the use of seatbelts is excellent”) appeared on the state’s electronic highway signs.1 honestly pic.twitter.com/axXJwjbJrH — Nico Di Angelo Fan Blog (@Laney_Brynn) October 23, 2019 The story is funny, but illustrates [...]

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Oct 2019By |0 Comments

Do Patients Care About What Your Drug Does?

Do Patients Care About What Your Drug Does? By Sara Ray, MA Be sure the trial outcomes echo the patient voice, article says In most randomized pharmaceutical clinical trials, researchers are looking for a statistically significant performance difference between the two courses of therapy. But which is more important to the patient: Statistically significant improvement of a variable, or clinically significant improvement? “The operation was a success, but the patient died” is a succinct example of a misplaced sense of priorities. The patient was probably hoping for a better result than academic satisfaction. Here’s another example. [...]

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Oct 2019By |0 Comments

Clinical Trials and PROs: What Patients with Rare Diseases Say

Clinical Trials and PROs: What Patients with Rare Diseases Say By Kathleen Hoffman, PhD MSPH Challenges to developing clinical trials for rare diseases begin with their rarity – each condition affects fewer than 200,000 Americans. Approximately seventy-five percent of those affected by rare diseases are children. It is estimated that 80 percent of rare diseases are caused by genetic changes. Many rare diseases are progressive and debilitating. One third of the children affected by these conditions do not reach 5 years of age.1 Getting to a rare disease diagnosis can take years. In a way, it [...]

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Oct 2019By |0 Comments

What Members Tell Each Other About Clinical Trials

What Members Tell Each Other About Clinical Trials By Kathleen Hoffman, PhD MSPH "Failing to enroll a sufficient number of subjects in a trial is a long-standing problem"1 but understanding the factors impeding enrollment can be difficult. Public posts on social media are an effective resource for understanding how patients feel and what they understand about clinical trials. On Inspire, “clinical trials” are a popular topic. Close to 58,000 posts mention clinical trials. A cursory search of Inspire postings show the diversity of opinions and understandings: some member posts provide solid information, some members post incorrect [...]

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Oct 2019By |1 Comment

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 [...]

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Oct 2019By |0 Comments

The Kidney Cancer Support Community on Inspire

The Kidney Cancer Support Community on Inspire By Kathleen Hoffman, PhD MSPH Of the over 1 million cancers diagnosed each year in the US, around 3 percent are kidney cancers.1 This relatively rare cancer is twice as likely to develop in men as women. Around 73,000 new cases will occur in the US in 2019, about 44,000 men and 29,000 women.2 Kidney Cancer Association Kidney Cancer Support Community on Inspire Started in 2014, the Kidney Cancer Association Kidney Cancer Support Community on Inspire has grown to approximately 2600 members; 64 percent are female, 36 percent male. [...]

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Sep 2019By |0 Comments

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

How Does Pharma Learn to Speak Patient? The “Patient Voice”

How Does Pharma Learn to Speak Patient? The "Patient Voice" By Sara Ray, MA We have all, at one time or another, been patients. True or false? If you answer true, it is likely that you are a person who has experienced only acute illnesses, meaning you get sick, feel lousy, get treated, you feel better. You return to your normal activities. You get back to life. Before getting to the language of patients or “patient voice,” it is useful to understand that “we are not all patients.” Carolyn Thomas, writer and patient advocate, explains that, [...]

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Jul 2019By |0 Comments

Researching Treatment Options Online Impacts Decision-Making

Researching Treatment Options in Online Communities Impacts Decision-Making By Kathleen Hoffman, PhD, MSPH Inspire members don’t just give each other encouragement – they often educate each other through their posts, and take new information to their own doctors. Some members have even found specialists in their conditions and chosen doctors and treatments based on what they learned from the Inspire community. Here are posts from some members talking about their experiences. Today I had another one of those 10-15 minute protocol meetings with my onc [oncologist] as I approach the end of yet another round on [...]

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Jun 2019By |0 Comments