Ken Getz, assistant professor at Tufts Center for the Study of Drug Development (CSDD), reports that oftentimes procedures performed in the last drug development stages are in order to find “supplementary, secondary, tertiary, and exploratory endpoints.”...
In a recent article by Outsourcing-Pharma, Harvard Medical School scientists from Beth Israel Deaconess Medical Center (BIDMC) claim to have identified genetic differences between people who respond to placebos during trials and those who do not. Only 122 of the 262...
The Coalition For Accelerating Standards and Therapies (CFAST) was introduced at the CDISC International Interchange in Baltimore October 22-26. By congregating experts from each industry, data standards are expected to be maintained and developed. The coalition...
The Presidential Commission for the Study of Bioethical Issues, a government advisory panel, released a statement reinforcing the need for privacy protection for those who choose to submit their whole genome sequencing for the purpose of medical research. Genomes...
In a recent article from Outsourcing-pharma.com, the Association of Clinical Research Organization (ACRO) is voicing their opinion on the misrepresentation of trial participants as test monkeys. The VP of ACRO, John Lewis made sure to note that research trial...
Effective September 26,2012 Health and Human Services has assigned responsibility to FDA for enforcing reporting by sponsors on ClinicalTrials.gov. Based on a notice by the Federal Register, FDA is now responsible for keeping track of the database’s most recent...