Cardiovascular outcomes trials (CVOTs) are some of the
largest interventional trials being conducted, enrolling several
thousand subjects, sometimes with follow-up of several years
to accrue the required number of major adverse cardiovascular
events. By contrast, and for obvious reasons, rare disease
studies are very limited in size. However, the general design of
these two trials is similar. Philip Galtry, Vice President, Clinical
Development and Cinzia Dorigo, Executive Director, Clinical
Development for Rare Disease and General Medicine, INC
Research, try to figure out why.