What are clinical trial materials (CTMs)?

Clinical trial materials (CTMs) refer specifically to the pharmaceuticals that are produced for use in clinical trials, where their efficacy and safety are evaluated in controlled settings with human subjects. The primary purpose of these materials is to gather the necessary data that will support a drug's approval by regulatory authorities and help determine appropriate dosages, side effects, and overall effectiveness.

Understanding the context, CTMs are not products that are already available in the market; they are manufactured with the aim of conducting trials to assess new or modified pharmaceuticals. This differentiates them from raw materials or intermediates used in drug manufacturing, as well as finished products that are waiting for regulatory review. Therefore, the focus on CTMs as items explicitly created for clinical evaluation purposes highlights the significance of their role in the drug development process.