Data presentation in industry-sponsored cardiac device trials

Abstract

Industry's influence on clinical trials is well known and extends to various aspects beyond funding, including industry-affiliated authors and industry-affiliated analysts. An area of potential concern is presentation of analyzed data that does not appear favorable to the desired study outcome. Such important data are at times not accorded prominence in discussion. The present article analyses such concerns in data presentation in the landmark trials of two cardiac devices the use of which has increased markedly in recent years (DanGer Shock trial and COAPT trial). It is seen that important data that did not appear favorable to the intended study outcome were relegated mostly to Supplement Section, where they are likely to receive less attention, with little discussion allocated in the text.