Newtown, PA (January 2019) – The Bracken Group announces today the submission of their response to the Food and Drug Administration (FDA) regarding the new draft guidelines on compliance with clinicaltrials.gov. The letter suggests the use of novel technology to monitor ClinicalTrials.gov compliance developed by BrackenData, an industry-leader and creator of clinical trial intelligence solutions, in conjunction with its sister company The Bracken Group.
Since launching in 2000, ClinicalTrials.gov, (CT.g) the online registry for clinical trials in the United States, has registered nearly 300,000 studies. Founded to increase transparency about public and privately sponsored clinical trials, the requirements have continued to expand. In 2008 ClinicalTrials.gov further expanded database requirements for study results from the registered trials adding to the existing compliance requirements.
The September 2018 FDA guidance details the fines that can be levied for non-compliance of CT.g. There are several reasons for non-compliance, but arguably the two most common are not providing annual updates and not submitting the study results within 12 months of last subject visit. The rate of compliance is 70.6 percent for all studies that are currently recruiting and only 35.4 percent for all studies within the registry. These trials can be easily identified, and the compliance data tracked, via BrackenData’s Trial Compliance tool.
Maintaining trial compliance is time consuming and has to be processed in a standardized manner. The Bracken Group has a regulatory team that provides CT.g registration and study results management. Combined with the tools from BrackenData, The Bracken Group’s expertise allows clients to remain compliant and avoid the fines that are likely to be levied based on the new guidelines and in federal legislation.
“Our data suggests the reasons for non-compliance are multifactorial. Keeping track of required updates to CT.g and the challenges of data entry/interface with complex trial data and the leading causes,” stated Colin G Miller PhD, Founder and CEO of BrackenData Managing Partner of The Bracken Group. He went on to say “The Bracken Group provides the service and monitoring tools to help companies avoid the fines that will be levied, when this new guidance becomes enacted.”
About The Bracken Group
The Bracken Group (TBG) is an executive consultancy for life science businesses, with a focus on players in the clinical trial ecosystem. TBG’s experts provide a variety of clinical trial related services, with a focus on due diligence, medical imaging operations, and regulatory consulting, with extensive experience in guiding development teams and investors from initial filing through regulatory approval. Expertise in regulatory support includes regulatory pathway strategy and process for submission of INDs, NDAs, BLAs, and MAAs; written and face-to-face communications with FDA & EMA; FDA meetings preparation for pre-IND, EOP2, pre-NDA, AdComs and “Clinical Path for Innovation meetings” (CPIM) and Voluntary Exploratory Data Submissions (VxDs) meetings; “VxDs” meetings to enable scientific and development discussions; and, therapeutic areas. Learn More About The Bracken Group
BrackenData is a data analytics company that provides curated datasets in a user-friendly format using data analytic software. The datasets can be customized and use client data or publicly available datasets. Trial Compliance is one of the available data analytics dashboards that is underpinned by the information from www.clinicaltrials.gov. Other dashboards include TrialFinderTM and Site Finder.