David Sackett Trial of the Year Award

Selection Process

Each year the Society for Clinical Trials 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 humankind.
  • 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 deadline for nominations is March 1, 2017, and the award will be presented at the 38th SCT Annual Meeting, which is a joint meeting with ICTMC, May 7 - 10, 2016, in Liverpool, United Kingdom. To nominate the trial you think best meets our standards, send an email to Scott Evans (evans@sdac.harvard.edu), Chair of the David Sackett Trial of the Year Committee, with its citation and the reasons why you think it deserves the award. The nominated trial should have been published (either print or electronic) in calendar year 2016.

9th Annual Award Recipient (2016)

SCT Trial of the Year Award

Learning Early About Peanut Allergy (LEAP)

Selected by the Society for Clinical Trials as the 2015 Trial of the Year

Learning Early About Peanut Allergy Trial (LEAP), a randomized controlled trial, is the awardee of the prestigious 2015 David Sackett Trial of the Year Award, presented annually by the Society for Clinical Trials. Gideon Lack, Senior Investigator on the LEAP Trial accepted the award on behalf of the LEAP Trial team. Gideon Lack, a Professor of Paediatric Allergy, King's College London, Head of the Clinical Academic Paediatric Allergy Service, Guy's & St Thomas' NHS Foundation Trust, presented the LEAP trial on May 17th, 2016 at the Society's 37th Annual Meeting in Montreal, Canada.

Read the full press release »

Past Recipients


Mechanical versus Manual Chest Compression for Out-of-Hospital Cardiac Arrest (PARAMEDIC)
Mechanical versus Manual Chest Compression for Out-of-Hospital Cardiac Arrest (PARAMEDIC): a pragmatic, cluster randomised controlled trial, has been selected by the Society for Clinical Trials (SCT) as the 2014 Trial of the Year. The PARAMEDIC study team was awarded the 2014 Trial of the Year at the Society's 36th Annual Meeting.

The PARAMEDIC study team comprising trial investigators, a trial manager, a paramedic and patient/public representative discussed the trial following the award ceremony at the Hyatt Regency Crystal City in Arlington, Virginia during a plenary session on Tuesday, May 19, 2015 at 4:30 PM.
Click here for full press release »


The Randomized Trial of Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE)
The Randomized Trial of Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE) earned recognition as "Trial of the Year" by the Society for Clinical Trials (SCT) as the most noteworthy clinical trial published in 2013 that not only produced remarkable results but also marked a milestone in clinical trials of behavioral interventions. Gail Daumit, the lead author from the trial, accepted the award from 2014 Trial of the Year Committee Chair Larry Friedman at the SCT 35th Annual Meeting in Philadelphia.
Click here for photos from May, 2014 presentation and the full press release »


The Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART)
was presented by lead investigators at the Society for Clinical Trials 34th Annual Meeting at the Sheraton Boston, during a plenary session on Tuesday, May 21, 2013. The study (Silbergleit et al, New England Journal of Medicine, February 16, 2012), sponsored by the National Institute of Neurologic Disorders and Stroke, was conducted in children and adults using the emergency medical services system and a consent exception. As quoted from their publication, "This double-blind, randomized, noninferiority trial compared the efficacy of intramuscular midazolam with that of intravenous lorazepam for children and adults in status epilepticus treated by paramedics" and found "For subjects in status epilepticus, intramuscular midazolam is at least as safe and effective as intravenous lorazepam for prehospital seizure cessation." This means that emergency medical technicians have a quicker and more practical way of treating this life-threatening seizure condition even before patients reach the hospital.
Click here to view the Trial of the Year presentation and transcript »


The Maternal-Fetal Surgery For Myelomeningocele Trial (MOMS)
The award for 2012 was presented by Catherine Spong, Elizabeth Thom and Jody Farrell at SCT's 33rd Annual Meeting in Miami. Published in The New England Journal of Medicine in March 2011 (N Engl J Med 2011;364:993-1004) the MOMS trial compared prenatal versus postnatal surgery for myelomeningocele (spina bifida). The trial was stopped because of superior results with the prenatal surgery after 183 patients had been enrolled (out of a planned 200). The primary outcome of fetal or neonatal death or the need for placement of a cerebrospinal shunt by one year of age occurred in 68% of those undergoing prenatal surgery and 98% of those undergoing postnatal surgery. The MOMS trial faced great difficulties in recruiting women who had recently received a devastating diagnosis, entailing counseling and providing considerable information and resources about options and ethical considerations. Those randomized to prenatal surgery needed to remain close to the participating clinical center. The effort required to overcome the many obstacles in the conduct of this important trial was a key factor in its selection as Trial of the Year.


The award for 2011 was presented at SCT's Annual Meeting in Vancouver, BC, Canada on May 17th. "The Ekjut Trial in Jharkhand and Orissa" earns recognition as "Trial of the Year" by the Society for Clinical Trials 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. The trial's co-investigator, Dr. Prasanta Tripathy, presented an overview of the trial methods and findings. 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 randomized 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%.


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 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 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).


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David Sackett Trial of the Year

SCT Trial of the Year Award
9th Annual Award (2016)
“Learning Early About Peanut Allergy (LEAP)”
Read the full press release »
Past & Present Winners »

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