CNSP - FDA Releases Clinical Trial Guidelines Taking into Account CNS Metastases
The Food and Drug Administration recently released new guidance informing sponsors of clinical trials on recommendations to trial designs for systemic oncologic treatments in individuals with central nervous system metastases. According to the new guidelines, researchers must consider leptomeningeal disease, end points, central nervous system assessment, prior therapies and patient population when designing clinical trials. The assessment of tumors is best done through magnetic resonance imaging (“MRI”) with gadolinium contrast.
The agency recommends that the involvement of the central nervous system (“CNS”) not be assessed separately from other metastatic illnesses present in other parts of a patient’s body. It adds that limited effectiveness reporting, including progression-free survival or overall response rate, even when supported by discoveries...
NOTE TO INVESTORS: The latest news and updates relating to CNS Pharmaceuticals Inc. (NASDAQ: CNSP) are available in the company’s newsroom at http://ibn.fm/CNSP
About BioMedWire
BioMedWire (BMW) is a bio-med news and content distribution company that provides (1) access to a network of wire services via InvestorWire to reach all target markets, industries and demographics in the most effective manner possible, (2) article and editorial syndication to 5,000+ news outlets (3), enhanced press release services to ensure maximum impact, (4) social media distribution via the Investor Brand Network (IBN) to nearly 2 million followers, (5) a full array of corporate communications solutions, and (6) a total news coverage solution with BMW Prime. As a multifaceted organization with an extensive team of contributing journalists and writers, BMW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. By cutting through the overload of information in today’s market, BMW brings its clients unparalleled visibility, recognition and brand awareness. BMW is where news, content and information converge.
To receive SMS text alerts from BioMedWire, text "STOCKS" to 77948 (U.S. Mobile Phones Only)
For more information, please visit https://www.BioMedWire.com
Please see full terms of use and disclaimers on the BioMedWire website applicable to all content provided by BMW, wherever published or re-published: http://BMW.fm/Disclaimer
BioMedWire (BMW)
San Francisco, California
www.BioMedWire.com
415.949.5050 Office
Editor@BioMedWire.com
BioMedWire is part of the InvestorBrandNetwork.