The House of Representatives recently completed the last step in processing a bill that will compensate patients with rare diseases involved in clinical trials. The Ensuring Access to Clinical Trials Act of 2015 would allow compensation of up to $2,000 to...
As covered in an article by Zachary Brennan in raps.org, the ICH has updated their GCP guideline with the goal to simplify and cut the cost of clinical trials. The aim is to create a more “unified standard for the regulatory authorities in the EU, Japan, US, Canada...
A recent study has shown that the combinations of specific drugs have a positive effect on lowering hypertension for people with high blood pressure. Using big data, researchers have been able to identify unknown effects of specific drugs. This creates a quicker and...
After implementing a new transparency program requiring sponsors to register their trial on Clinicaltrials.gov and identify study outcomes, it was found that only 8% of clinical trials report positive results. Clinical trials performed from 2000 to 2012 reported...
Approximately one third of all FDA-approved drugs carry a boxed warning in the manufacturer’s full prescribing information. Clinical trial consent forms document and facilitate the study participant’s consent process. Bhattacharya et al (2015) assessed whether...
Every so often, clinical tries are said to ‘fail’, but can the trial actually fail? According to John Lechleiter, President and CEO of Eli Lilly and Company, “a clinical trial is a failure only if we can’t learn from it.” He believes that no matter how a clinical...
