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UK Changes Approach To Trials In Patients With Prior ATMP Therapy

 
• By Vibha Sharma

New UK guidance outlines points to consider when planning clinical trials in patients previously treated with an advanced therapy medicinal product. 

Clinical trial
Previous ATMP use has been a standard exclusion criterion for trial participation • Source: Shutterstock

The UK Medicines and Healthcare products Regulatory Agency has issued guidance explaining when it may be appropriate for clinical trials to include patients previously treated with an advanced therapy medicinal product (ATMP).

Previous use of an ATMP – such as CAR-T cell therapy, gene and cell therapy products and tumor vaccines -...

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