Clinical trials in adult respiratory distress syndrome.

The need for randomized clinical trials in adult respiratory distress syndrome (ARDS) is now recognized. With this recognition comes the need for researchers to implement proper trial design and for the clinician to be able to interpret results as they apply to clinical practice. The heterogeneity of ARDS as related to etiology, stage, and severity creates the potential for maldistribution of patients in the clinical trial. Likewise, a particular intervention may benefit or not benefit a patient based on these variables. Choosing a minimum of end-points (ideally one) for hypothesis testing is important. The optimal end-point for hypothesis testing pertinent to clinical impact is all-cause mortality at a certain time point (usually 14 or 28 days). Unblinded trials are suboptimal, but necessary, with interventions such as mechanical ventilation treatment modalities. Given these circumstances, treatment protocols should be utilized in both groups. Cooperation of the basic scientist and the clinical scientist is ideal for direction of research in ARDS. Industry funding of ARDS clinical trials is now typical and needed. Under these circumstances, it is important to prevent inappropriate industry influence on trial design, data analysis, data interpretation, and data presentation. The investigator must remain above reproach and the informed consent process must be of the highest standard.