In a report prepared by FDA staff ahead of the meeting of the Antimicrobial Drugs Advisory Committee on August 7 to discuss the supplemental new drug application submitted by Gilead Sciences for Descovy, the staff wrote: "Clinical trial data
from the DISCOVER trial submitted in support of this application show that Descovy and Truvada were similar in reducing HIV-1 infection in MSM and TGW.
China has relaxed restrictions to allow clinical trial data
from abroad to be used.
"We're pleased that we succeeded in transferring core data types collected in health care provider electronic health records to Pfizer's clinical trial data
capture system using FHIR [Fast Healthcare Interoperability Resources] standards," said Rob Goodwin, Pfizer's vice president of global product development and operations center of excellence.
The company stated that the study is designed to evaluate avapritinib's safety and efficacy, with progression-free survival as the primary efficacy endpoint and based on the NAVIGATOR Phase I clinical trial data
, avapritinib was administered to 109 fourth-line or later GIST patients at doses of 300mg or 400mg.
TherapeuticsMD says that BIJUVA will be available Spring 2019 and is a proven treatment option for women who are experiencing bothersome symptoms of menopause, with clinical trial data
demonstrating a statistically significant reduction in both the frequency and severity of moderate-to-severe vasomotor symptoms.
Jersey City-based TrialScope, a clinical trial disclosure and transparency management technology company, announced on Wednesday a strategic partnership with Washington-D.C-based Vivli, a nonprofit focused on sharing of clinical trial data
John Welsh, from Yale-New Haven Hospital in Connecticut, and colleagues conducted a cross-sectional analysis of randomized clinical trials to characterize the age of clinical trial data
at the time of publication in journals with a high impact factor.
Keytruda and Opdivo continue to produce significant clinical trial data
for numerous tumor types.
OZMOSI has launched a new global website which consolidates clinical trial data
from all around the world into a single searchable database, GlobalClinicalTrialsData.com.
Sharing clinical trial data
is one step in the process articulated by the World Health Organization (WHO) and other professional organizations as best practice for clinical trials: universal prospective registration; public disclosure of results from all clinical trials (including through journal publication); and data sharing.
If you've ever used websites to purchase medications, take heed: the reviews tend to portray the products in a far more positive light than clinical trial data
, according to the first study to compare the two.