Requirements to participate in haemophilia clinical trials.

ABSTRACT

INTRODUCTION: Clinical trials in haemophilia product development are expanding rapidly however, the number of sites and expertise in the clinical trial conduct is limited. Guidance on the requirement for conducting clinical trials is required AIM: The aim of this paper is to outline generic requirements to participate in clinical trials in haemophilia MATERIALS This paper describes three elements which are the requirements for success conduct of haemophilia clinical trials. These are the study product, study participant, and the global regulatory and ethics framework RESULTS AND CONCLUSION: In haemophilia clinical trials, requirements for participate in studies are many and include considerations of study product, study participant and ethical and regulatory framework. When these elements are in place, it is possible to conduct haemophilia clinical trials anywhere in the world.