Clinical Trials of Novel Therapeutic Agents: Why did they fail?
Clinical trials of sepsis have been described as “The Bermuda Triangle of the Biotechnology Industry”, or perhaps more aptly a “black hole” into which large sums of money and resources disappear with no visible return. The unexpected and generally disappointing results of clinical trials for sepsis has been the subject of numerous editorials and critical commentaries [1–5]. Several thousand patients have been enrolled in randomized trials of immunotherapy of severe sepsis; yet, no single agent has demonstrated sufficiently convincing clinical data to warrant licensure as an approved therapeutic agent. It is imperative that we determine the cause(s) of these failures as we continue to attempt to develop adjuvant therapies for this common and potentially lethal condition. These results have prompted investigators to consider a number of critical questions raised by recent failures in sepsis trials.
KeywordsSeptic Shock Septic Patient Sepsis Syndrome Immunotherapeutic Agent Sepsis Trial
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