All of us in research are aware of the challenges with length and understandability of informed consent documents. In a new article found in the December issue of Anesthesiology News entitled “Uninformed Consent: Average Study Participant Likely Unaware of...
A group of bipartisan senators introduced a plan to streamline the FDA’s regulation that would speed up the process of taking innovations to the market and encourage innovation. The bill would also focus on restoring balance to the conflict of interest...
At the end of September, I blogged about the important Cancer Prevention Study-3 which came to our hometown Indianapolis, Indiana this month. Well, I did it…I volunteered for my first clinical research study. Oh sure, I have taken surveys before, even...
The FDA is working on developing a quality-by-design (QbD) model for clinical trials that would cut monitoring costs. The plan is to implement the model within the next 25 years. There is already a QbD model is place for manufacturing that allows for the quality...
Recently at a conference held by the Institute of Medicine (IOM), low participation in new clinical trials and research were discussed between industry professionals. One viewpoint states mistrust of clinical trials, science in general and the motives of the industry...
