So sorry for the silence! I've been working on many topics and issues, and you will hear about them soon. I also forgot to share this guest blog post I did back in March 2017. The Clinical Trials Arena post, Trial Results Create a Win for Patients and Companies, covers the reasons trial summaries need to make … Continue reading Trial results create a WIN for all!
My blog guests this week are Amy Conn, Bruce Bloom, and Clare Thibodeaux from Cures Within Reach. Disclosure: I am a member of their Advisory Board, and think that testing older drugs for rare diseases is brilliant! The power of repurposing What if the latest treatment for cancer, diabetes or thousands of other unsolved diseases … Continue reading How to Solve Diseases with Existing Drugs
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
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?
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.