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
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!
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
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
Click here for useful tips on making public comments about the changes to informed consent before 12/7/15. EDIT: the public comment period has been extended - post your comments before 1/5/2016. More information in this blog post and at this website.
My favorite season! Thanks to those who supported our fundraiser at the Alliance for Clinical Trials In Oncology Foundation. More hand-crafted jewelry pictures available here. All content © 2015 by Deborah Collyar unless otherwise specified. All rights reserved. Permission is granted to use short quotes provided a link back to this page and proper … Continue reading Autumn Memories
Creating plain language study result summaries for people is becoming popular these days, thanks to a recent regulation from the European Medicines Agency (EMA). Link to article enclosed.