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
No, really. This is a real thing, created by money. Oops, I meant to say, created by researchers and institutions with MAJOR conflicts of interest. Why post it? Well, while this is the most blatant example we've seen in a long time, it happens every day, even to well-meaning researchers. FACT: research is a money game. … Continue reading Oops! Don’t Buy Chocolate Milk for Concussions
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?
Welcome to the controversial world of dietary recommendations. Seriously, what do you do when you hear opposing stories about fat, cholesterol, carbs, supplements, etc.? Probably the same thing the experts do - expound on your own opinions and go get a snack! Debate from All Sides Criticism ignited over recent U.S. Dietary Guidelines (USDG), which diluted evidence that disagrees with long-held … Continue reading Quality Diet Research Needed
Congratulations to the MRCT Center of Brigham and Women's Hospital and Harvard and team for winning the 2015 Award for Excellence in Human Research Protection from the Health Improvement Institute! The winning project recommends ways to write public summaries after a clinical trial is over. Why Is This Important? People join clinical trials (research studies) so researchers … Continue reading Clinical Trial Patient Summaries Win!