sct/ImpACT trial of the year

Each year the Society for Clinical Trials and Project ImpACT presents an award to the randomized clinical trial published (either electronically or in print) in the previous year that best fulfills the following standards:

• It improves the lot of mankind.
• It provides the basis for a substantial, beneficial change in health care.
• It reflects expertise in subject matter, excellence in methodology, and concern for study participants.
• It overcomes obstacles in implementation.
• The presentation of its design, execution, and results is a model of clarity and intellectual soundness.

The first annual "SCT/ImpACT Trial of the Year" award was given in 2008 to Dr. Barbara Schmidt and her colleagues for their RCT of I-V caffeine for premature infants with apnea, a treatment that had been in irregular use for decades but never rigorously tested.  In a challenging multicenter international trial of 2006 babies, they demonstrated not only reduced mortality from caffeine, but also reductions in cerebral palsy and developmental delay (N Engl J Med 2007;357:1893-1902).

The award for 2009 was presented at a special session of our Atlanta annual meeting to Dr. Christopher Bulpitt and his colleagues for their “Hypertension in the Very Elderly Trial (HYVET).”  Carried out in 195 centers in 13 countries in Western and Eastern Europe, China, Australasia, and North Africa, they enrolled 3, 845 women and men with persistent hypertension (systolic blood pressure of 160 mmHg or more) who were 80 years of age or older and were living independently.  Over the next two years, the octogenarians randomized to mild blood pressure lowering drugs were a third less likely to suffer strokes, two-thirds less likely to go into heart failure, and one-fifth less likely to die than their fellow participants who had been randomized to placebos.  These benefits began to appear within the first year of treatment, and there was no increase in drug side-effects (N Engl J Med 2008;358:1887-98). 

The award for 2010 was presented at a special session of our Baltimore annual meeting to Prof. Fritz Schroder and his colleagues for their “European Randomized Study of Screening for Prostate Cancer (ERSPC)” Trial. It identified 182,000 men between the ages of 50 and 74 years in The Netherlands, Belgium, Sweden, Finland, Italy, Spain, and  Switzerland, and randomized them to be/ not be offered Prostate Specific Antigen (PSA) screening every 4 years. The rate ratio for death from prostate cancer in the screening group, as compared with the control group, was 0.80 (95% confidence interval [CI], 0.65 to 0.98; adjusted P = 0.04).   The trial concluded that PSA-based screening reduced the rate of death from prostate cancer by 20% but was associated with a high risk of over-diagnosis. (N Engl J Med 2009;360:1320-8)

We are now accepting nominations for the outstanding Trial of the Year published (either electronically or in print) in 2010.  The deadline for nominations is January 31, 2011, and the award will be presented at our annual meeting in Vancouver. Please click here to nominate a trial you think best meets our standards.