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FDA Adapts Drug Development Tool Procedures to Adopt Alzheimer’s Simulation Tool

 
• By Jacqueline Fitton

FDA recently featured an Alzheimer’s Disease clinical trial simulation tool as another positive, but low-visibility, step toward improving the drug development pathway for the disease. The process for accepting the tool may be as important as the tool itself.

FDA Commissioner Margaret Hamburg posted an “FDA Voice” blog

piece in early April to praise the persistent advocacy efforts in the search for treatments for Alzheimer’s disease—if not the...

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More from Clinical Trials

Brazil Looks To AI And Digital Technologies To Revitalize Clinical Research Environment

 
• By Francesca Bruce

Brazil is planning to update its National Clinical Research Action Plan to make the country a more competitive location to conduct R&D.

Survey Highlights Long Road Ahead For UK To Becoming Clinical Trials Hub

 
• By Eliza Slawther

Commercial clinical trial sponsors have reported several challenges with setting up trials in the UK, which led the Health Research Authority and its partners to make “significant improvements,” to the process, a senior figure at the organization has said.

How England’s Cancer Vaccine Launch Pad Helped Scancell Speed Up Trial Patient Recruitment

 
• By Anabel Costa-Ferreira

As the CVLP prepares to support its third cancer vaccine trial, the Pink Sheet examined Scancell’s experience with the initiative, which the drug company used to recruit patients for its advanced melanoma vaccine trial.

New UK Network Targets Speed And Inclusion For Commercial Clinical Trials

 
• By Vibha Sharma

The UK government expects that its new nation-wide network will enable companies to set up clinical trials more quickly and expand access to diverse patient populations across the National Health Service.

More from R&D

New UK Network Targets Speed And Inclusion For Commercial Clinical Trials

 
• By Vibha Sharma

The UK government expects that its new nation-wide network will enable companies to set up clinical trials more quickly and expand access to diverse patient populations across the National Health Service.

Oncology: Plan Ahead To Rule Out Harm When Survival Not The Endpoint, US FDA Says

 
• By Michael McCaughan

The FDA recommended sponsors plan ahead for potential issues if overall survival is not feasible as a primary or secondary efficacy endpoint in clinical trials and must be analyzed as a safety outcome.

Selective Safety Data Collection In Clinical Trials: Adoption Lags Despite Benefits, US FDA Says

 
• By Manas Mishra

Lack of awareness is limiting use of guidelines that simplify safety reporting for some late-stage trials, FDA says, while also highlighting wins. Boehringer experienced mixed results, while Novartis, Lilly, and Merck were more successful, and Roche should have probably tried, white paper suggests.