The company has committed to provide lay-language summaries of
clinical trial results for patients who participated in
clinical trials and wish to receive a summary of the aggregate study level results.
This has resulted in multiple entries of a single
clinical trial and has thus diminished the credibility of the registries.
Since 2007, the FDAAA has required all Phase II-IV
clinical trials involving drugs, devices or biological products subject to regulation by FDA (applicable
clinical trials) to be registered on www.clinicaltrials.gov.
Randomized
clinical trials design, practice and reporting, David Machin & Peter M.
Corengi is dedicated to helping individuals discover more about
clinical trials that may be appropriate for them, and committed to building a free, comprehensive, and interactive platform for a variety of diseases.
Upon recognition of the barriers contributing to low cancer
clinical trials accrual in the state, the newly formed West Virginia Oncology Society, Mary Babb Randolph Cancer Center, David Lee Cancer Center (Charleston Area Medical Center, Charleston), Edwards Comprehensive Cancer Center (Marshall University-Huntington), Schiffler Cancer Center (Wheeling Hospital), United Hospital Center (Clarksburg), City Hospital (Martinsburg, West Virginia University-Eastern Division) are working together to establish a cancer
clinical trial network to address these issues.
Within about three months of its launch the response received has been overwhelming with over 90
clinical trials already registered.
Originally, pharmaceutical and medical device companies contracted with CROs to perform some or all of the
clinical trials necessary to obtain regulatory approval to bring a product to market rather than always maintaining the large staff necessary for these operations on their own payrolls.
A
clinical trial prepared by investigators with hefty bonuses at stake will probably receive more intense government scrutiny as the numbers come in.
Global
Clinical Trial Services Industry Market Analysis
[ClickPress, Tue Sep 03 2019]
Clinical trial management systems are central to eClinical environments, and considering the paramount focus on product safety and efficiency, there is a palpable shift towards better functionality and standardization.
