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

Participation is Personal: Community Outreach Impacts Clinical Trial Diversity

Participation is Personal: Community Outreach Impacts Clinical Trial Diversity By Kathleen Hoffman, PhD, MSPH Despite FDA policy initiatives over the last few decades, certain groups continue to be unnecessarily underrepresented in many clinical trials.1 The Yale Center for Clinical Investigation (YCCI) at the Yale School of Medicine is tackling this problem with local resources. Since its inception in 2005, part of YCCI’s mission has been to: “...Strengthen the infrastructure that connects clinical research teams with practitioners, community health clinics, and community stakeholders throughout Connecticut, reaching out in particular to diverse populations including children, women, the elderly, [...]

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Jan 2020By |0 Comments

No “One Size Fits All” Solution to Improve Clinical Trial Participation

No "One Size Fits All"Solution to Improve Clinical Trial Participation By Kathleen Hoffman, PhD, MSPH Clinical trial study designers are trying to find ways to increase participation and reduce dropout. According to three recent studies, the reasons patients give for not participating in clinical trials vary depending on a number of factors including the condition being studied, the gender or age of participants, and even minority status. Accommodating these differing needs in the study design would support enrollment and sustain participation, but it requires asking prospective participants what would lower the barriers for their specific condition [...]

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Jan 2020By |0 Comments

Where Can I Get This ‘Real World Data’ You Speak Of?

Where Can I Get This ‘Real World Data’ You Speak Of? By Robert Gardner How far has the importance of Real World Evidence advanced as part of treatment development? When the attendees of a recent eyeforpharma webinar were asked, “Are you, or will you soon be using RWE for enabling new types of value or outcomes-based assessment within your own firm?” 35 percent responded that they already consider RWE “a universal and necessary standard,” with another 26 percent saying RWE is or will be used as evidence in developing “specialty and high-priced treatments.” A “universal and [...]

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Dec 2019By |0 Comments

Patient Centricity: Joining Qualitative with Quantitative

Patient Centricity: Joining the Qualitative with the Quantitative By Kathleen Hoffman, PhD, MSPH Reams of market research and data can provide insight, but so can one patient in the room, telling you what really matters to them.1~Paul Tunnah, PharmaPhorum founder The FDA’s drug approval process requires developers to submit quantitative data demonstrating that the treatment is safe and effective after testing in a representative target population. But if you’re accustomed to using quantitative studies to attain approval, you might be feeling jaded about patient centricity guidances. As Tunna’s article says, “...everyone seems keener to shout about [...]

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Dec 2019By |0 Comments

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 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

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 [...]

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Jun 2019By |0 Comments