Newsletter - October 17, 2019
The Power of One: Using One-Patient Trials for FDA Approval
A one-patient clinical trial could lead to a heartwarming story but requires incredible motivation and endless resources, and presents formidable regulatory, scientific and practical challenges for use beyond that one patient as is highlighted by such a trial reported this week. Doctors at Harvard Medical School, Boston Children’s Hospital...Read More
For FDA Acceptance of Real World Data Do Better Observational Studies
Only 15% of clinical trial data could be replicated using real world data (RWD) from electronic health records and insurance claims databases by researchers trying to evaluate if RWD could replicate clinical trial evidence and potentially replace clinical trials. The report highlighted well known limitations of patient records...Read More
The Power of One: Using One-Patient Trials for FDA Approval
A one-patient clinical trial could lead to a heartwarming story but requires incredible motivation and endless resources, and presents formidable regulatory, scientific and practical challenges for use beyond that one patient as is highlighted by such a trial reported this week. Doctors at Harvard Medical School, Boston Children’s Hospital...Read More
For FDA Acceptance of Real World Data Do Better Observational Studies
Only 15% of clinical trial data could be replicated using real world data (RWD) from electronic health records and insurance claims databases by researchers trying to evaluate if RWD could replicate clinical trial evidence and potentially replace clinical trials. The report highlighted well known limitations of patient records...Read More
