Attitude is a far better indicator that you’ve got a good clinical research prospect than tenure, says Lorene Ward, senior clinical research associate with Syneos Health, a North Carolina–based integrated biopharmaceutical solutions organization including a contract research organization and a contract commercial organization. In her prior role as a research manager with a small psychiatric […]
Ready or not, virtual clinical trials (VCTs) are here to stay. As new technologies make them easier to conduct, and as patients demand more flexibility to participate in trials, this new way of doing business will only become more attractive and prevalent, says John Reites, chief product officer and partner with THREAD. “Remote virtual trials […]
On May 22, 2018, the U.S. House of Representatives enacted a controversial bill to allow sick people to circumvent the Food and Drug Administration (FDA) to get access to unapproved medicines. The House took up a Senate-passed “right to try” bill (S. 204) and passed it by a vote of 250 to 169. S. 204 […]
To mark National Women’s Health Week, Food and Drug Commissioner Scott Gottlieb reaffirmed the “importance of making sure women are appropriately represented in clinical trials.” He applauded the U.S. Food and Drug Administration’s (FDA’s) Office of Women’s Health (OWH) and its work in providing more than $40 million for 371 projects to “inform the FDA’s […]
Maybe it’s time to show the U.S. Food and Drug Administration (FDA) a little love. “In 2017, FDA was the agency with the shortest median approval time (243 days), which is likely due to the wide use of facilitated regulatory pathways (FRPs) that year, where 40% of [new active substance (NAS)] approvals were designated as […]