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!
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
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.