Blog
Could the Sunshine Act be the cause of decline in research funding?
According to a recent article in News-Medical.net, the Sunshine Act’s new Open Payments plan could potentially be the cause of a dramatic downfall in U.S. clinical research. Research conducted from the U.S. Open Payments database has shown that between 2013 and 2014,...
Positive results in clinical trials down to 8% in recent years
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...
Are disclosure forms important?
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 boxed...
CFDA allows for drug self-inspections
In July, China’s Food and Drug Administration (CFDA) allowed self-inspections to occur for imported and local drugs. Although CFDA is allowing self-inspections for drugs, it will also be conducting random on-site inspections upon the reports that companies give them....
Caldwell highlighted in HBA’s newsletter
The Health Businesswomen’s Association (HBA) interviews Diana Caldwell, President and CEO of Pearl Pathways. HBA has been around for four decades and is focused on connecting businesswomen through sharing career information. HBA’s interview was performed on July 20th,...