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)
The SCT has named “The Ekjut Trial in Jharkhand and Orissa” as recipient of its 4th Annual Trial of the Year award. The Jharkhand and Orissa Trial was recognized as an extraordinary cluster randomized controlled trial, conducted with high quality in a very difficult setting, and achieving dramatic results of great public health importance.
Published in The Lancet in March 2010 [Lancet 2010;375: 1182-92], the “Jharkhand and Orissa” trial was a cluster randomized trial in very poor communities in eastern India. The goal of this study was to reduce neonatal mortality rates and maternal depression. The investigators successfully randomised 36 clusters (10-12 villages per cluster) in three districts to a community intervention (vs. none) which involved using or organizing village women’s groups, who engaged in participatory learning and action through play, stories and games. Group members themselves identified newborn health problems within the community and selected their own strategies to address the problems, which they then implemented. After three years of the intervention, neonatal mortality was reduced by 45% and maternal depression by 57%.
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Nominations for 2011 Trial of the Year are now closed. The winner of the 2011 Trial of the Year will be announced in May 2012 and will be presented at the SCT Annual Meeting to be held May 20 - 23 at the Hyatt Regency Miami, Miami, Florida, USA.
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sct/ImpACT trial of the year
