There are many reasons why clinical trials don't work well. A major one is not making them useful or interesting to patients. I had high hopes when I heard about the recent clinical trial protocol (plan) template from the U.S. Food & Drug Administration (FDA) and the National Institutes of Health (NIH) Joint Leadership Council (JLC). Unfortunately, it looks like they … Continue reading Make Clinical Trials Better for Patients
Back in February, I spoke at the 2016 Arena International Outsourcing Clinical Trials West Coast Conference on "Patient Centricity" - a topic they gave me, along with some rather ambiguous objectives. I changed it to "Patients ARE the Endpoint" because it is time to get real about why the clinical trial industry exists in the first place. Yu … Continue reading Patients ARE the (end)Point of Clinical Trials
I've been asked countless times to write about patients and clinical trials. Guess it's time to share what I've learned, along with other patient advocates, as we work beside researchers in the proverbial trenches. Just so happens that this post coincides with April Fool's Day - hope that's not an omen! Why this series? This is the first in … Continue reading Getting Real about Patients & Clinical Trials
We learn about diseases and illnesses from research studies. Some focus on treatment (clinical trials), while others study groups of people (observational studies). Unfortunately, many studies are unclear, wrong, or can't be easily transferred into everyday medical practice. Study designs actually matter. They determine whether a research study helps real patients or just asks esoteric questions to further careers or … Continue reading How Do We Get Better Research Results?
Looks like 1,772 of us posted public comments about medical research informed consents to the NPRM docket! I realize this sounds obtuse, but bear with me through this post - please! So, What's the Big Deal? The final regulation will affect millions of patients, researchers, institutions, and companies. These rules last changed in 1991. You know, before the … Continue reading A Plan for Real Research Improvements
Clinical trials (research studies in people) can help find better treatment, care and prevention for patients. When done well, they answer important questions posed in the protocol (study plan) before the trial starts. Unfortunately, those answers are often not published. Some also don’t have the right study designs, which means the studies won’t tell us what we truly … Continue reading When Clinical Trials Don’t Match Their Data