[PHP44] Risk of Discontinuation of Advanced Therapy Medicinal Products Clinical Trials

[PHP44] Risk of Discontinuation of Advanced Therapy Medicinal Products Clinical Trials

2016 Value in Health

Hanna, E. | Rémuzat, C. | Toumi, M. | Volume: 19, Issue: 7, Pages: A821-A822,

Advanced Therapy medicinal products (ATMPs) constitute a class of innovative products that encompasses: gene therapy, somatic cell therapy and tissue engineered products (TEP). There is an increased investment of commercial and non-commercial sponsors in this field. Randomized clinical trials (RCT) generate data to prove the efficacy of a new therapy, but the discontinuation of RCTs wastes scarce resources. Our objective is to identify the number and characteristics of discontinued ATMPs trials in order to evaluate the rate of discontinuation.

https://www.doi.org/10.1016/j.jval.2016.08.627