A Clinical Trial Failed Patients

Something horrible happened - a clinical trial failed, causing one unexpected death and seriously injuring 5 people. And instead of dealing with a dysfunctional research system, “experts” are spouting off on their own. The few articles written to date focus on the drug (aka the money), not on what people want to know. My Initial Thoughts ClinicalTrialsArena asked … Continue reading A Clinical Trial Failed Patients

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Clinical Trial Patient Summaries Win!

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!

A Plan for Real Research Improvements

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

Last Chance to Say Your Word on NPRM

I posted "Informed about Changes to Research Consents?" on 11/15/15. You now have until 1/6/2016 at 11:58pm EST to send your comments about the changes that will affect hundreds of thousands of patients, researchers and institutions (at least). PLEASE send in your comments! Here's how: Read my blog post on 11/15/15 to refresh yourself, and feel free … Continue reading Last Chance to Say Your Word on NPRM

When Clinical Trials Don’t Match Their Data

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

Informed about Changes to Research Consents?

If not, you'll be surprised soon. The Common Rule is changing - 1st time since 1991. The US NIH NINR says, "The Common Rule contains regulations that protect individuals who participate in research and is followed by 18 federal agencies." Translation: these are the rules that apply to informed consent forms that patients sign to join research studies. Your … Continue reading Informed about Changes to Research Consents?

When is ‘Carcinoma’ not Cancer?

When it's called "Ductal Carcinoma In Situ" - also known as DCIS, Stage 0 or pre-invasive breast cancer, and other names too. DCIS is confusing. Some call it an early form of breast cancer while others want 'carcinoma' taken out of the name because it is NOT cancer. The debate heated up (again), based on some new … Continue reading When is ‘Carcinoma’ not Cancer?