Session 6 Clinical Trial Assessment Phase I （会话6第一阶段临床试验评估）.pdf

L1 Session 6 –Clinical Trial Assessment Phase I Clinical Trial Presentation to APEC Preliminary Workshop on Review of Drug Development in Clinical Trials Celia Lourenco, PhD, Manager, Clinical Group I Office of Clinical Trials Therapeutic Products Directorate 11 Slide 1 L1 Lourenco; 28.01.2008 Disclaimer: the information within this presentation is based on the presenters expertise and experience, and represents the views of the presenter for the purposes of a training workshop 2 Overview • Characteristics of Phase I trials • Core preclinical requirements • Considerations for biologics • Considerations for first-in-human • Preclinical testing of cytotoxic/cytostatic drugs • Phase I in Oncology, HIV/AIDS, Allergic Rhinitis/Asthma/COPD • Approaches in protocol and informed consent review • Common deficiencies • Exercises 3 Characteristics of Phase I Trials (1) • Subject population: healthy volunteers but for higher risk / potentially toxic drug products such as in oncology or most biologics, patients are recruited • Sample size typically around 20 • Single-dose escalation or repeat-dose range or escalation • Randomize