Mary Engel, writer for Fred Hutch News Service, stated the importance of clinical trials and patient involvement in her recent article. Participation in clinical trials is crucial to the development and success of finding new treatments because they are currently the...
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...
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...
