Surgery News

Report on different approaches to reduce Phase II attrition

February 25, 2016

Poorly predictive animal models constitute a major cause of drug attrition. We present two case studies in CNS and cancer, two therapeutic areas in which animal models are notorious for being poorly predictive. The CNS case study focuses on attempts to improve animal model efficacy studies, and the cancer case study focuses on industry's adoption of improved animal models developed in academia. In these discussions, we indicate how these particular case studies may have lessons for efficacy studies in most therapeutic areas.

Well-designed translational studies may enable drugs that do not work in humans to fail early. We examine various aspects of translational studies, including definition of responder versus non-responder populations, and optimal dosing regimens; and identification of early and sensitive markers of efficacy, and of those patients who are likely to experience adverse effects. Examples of ways in which translational medicine is changing the organization of clinical trials in some companies are discussed. We also study the roles that various types of biomarkers play in translational medicine, as well as the current state of biomarker science. Case studies on stratification biomarkers in cancer are presented.

Approaches to Reducing Phase II Attrition analyzes results from a survey of current practices and views toward improving the efficiency and effectiveness of drug development. Finally, the complete transcripts of interviews conducted with experts in the field are provided.

SOURCE Reportlinker