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. [...]

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 [...]

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 [...]