2023

Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage

Arlington Heights, Ill., May 6, 2024 -- The Society for Clinical Trials (SCT) is pleased to announce that the prestigious David Sackett Trial of the Year Award will be presented to the "Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage (E-MOTIVE)."

The award will be presented on May 20, 2024, as part of SCT's 45^th Annual Meeting, "It Takes a Village: Patient Centered Partnerships in Clinical Trials," May 19 - 22 at the Boston Marriott Copley Place Hotel. Accepting the award and presenting the trial will be Adam Devall, PhD, University of Birmingham, UK, on behalf of the E-MOTIVE team, led by Professor Arri Coomarasamy.

Since 2008, SCT has awarded the David Sackett Trial of the Year Award to a randomized, controlled trial published in the previous calendar 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 overcame obstacles in implementation.
• The presentation of its design, execution, and results is a model of clarity and intellectual soundness.
• The trial must be tied to a single publication (or a set of papers published simultaneously in a single journal).

Delays in detection or treatment of postpartum hemorrhage (PPH) can result in complications or death, killing around 70,000 women annually. The cluster-randomized E-MOTIVE trial aimed to address these delays following vaginal birth through a multicomponent intervention, which included a blood-collection drape and treatment bundle. Conducted across 80 hospitals in Kenya, Nigeria, South Africa, and Tanzania, the intervention group received this new approach, while the control group received usual care.

Results showed a significant reduction in the primary outcome, a composite of severe PPH (blood loss ≥1000mL), laparotomies, or maternal deaths from bleeding in the intervention group compared to usual care (1.6% vs. 4.3%; risk ratio, 0.40; 95% confidence interval [CI], 0.32 to 0.50; P<0.001). Additionally, PPH detection was higher in the intervention group (93.1% vs 51.1%) and also adherence to the treatment bundle (91.2% vs 19.4%) compared to usual care. This suggests that early detection and bundled treatment for PPH substantially mitigate its risks during vaginal delivery.

"This has been the largest set of nominations for the Trial of the Year Award in all my time on the committee. We received numerous nominations for worthy trials, from around the world and across a large number of clinical disciplines - including obstetrics, emergency medicine, infectious disease, and cancer," said Andrew Cook, MBBS, MPH, Chair of the SCT David Sackett Trial of the Year Committee. "We had a challenging time as a committee to choose a winner, and it was a close-run thing. We look forward to Dr. Devall telling us more about the winning trial at the SCT annual meeting."

Nominations for the David Sackett Trial of the Year are submitted by Society members, investigators, and interested scholars from around the world. The 2023 David Sackett Trial of the Year Committee included: Andrew Cook (chair), Jessica Overbey (co-chair), Karla Ballman, Tracy Bergemann, Jonathan Cook, Suzanne Dahlberg, Sonia Jain, Yan Lin, Theodore Lystig, and Sameer Parpia. Dr. David L. Sackett was a dedicated long-time SCT member, a pioneer in evidence-based medicine and champion of clinical trials.

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2022

The Chronic Hypertension and Pregnancy (CHAP) Trial

Arlington Heights, Ill., April 27, 2023 -- The Society for Clinical Trials (SCT) is pleased to announce that the prestigious David Sackett Trial of the Year Award will be presented to The Chronic Hypertension and Pregnancy (CHAP) Trial.

The award will be presented on May 24, 2023, as part of SCT's 44th Annual Meeting, "Championing High-quality Evidence to Optimize Human Health," May 21 – 24, 2023 at the Baltimore Marriott Waterfront Hotel. Accepting the award and presenting the trial will be Dr. Alan T. Tita, Senior Vice Chair for Research and Innovation, Department of Obstetrics and Gynecology, Center for Women's Reproductive Health, Mamix E. Heersink School of Medicine, University of Alabama at Birmingham.

The Chronic Hypertension and Pregnancy (CHAP) trial evaluated the effects of prescribing blood pressure medication to pregnant people with mild chronic hypertension. With over 2,408 randomized participants at 61 US sites, CHAP is the largest and most diverse study of its kind.

According to the nomination submitted by Dr. Tita, chronic hypertension is a common medical disorder that causes life-threatening complications for pregnant people and their babies. At least 70% of pregnant women with chronic hypertension fall into the 'mild' category where there was not a medical consensus on whether to treat with medications as recommended in non-pregnant patients. This uncertainty stemmed primarily from concerns that treatment would affect the baby's growth in the absence of proven benefits.

The research reported there was a 20% decrease in pregnancy complications, including severe preeclampsia and preterm birth before 35 weeks, for women treated with medication compared to no treatment. There were no differences in new-born size or other outcomes. CHAP led to a charge in national guidelines.

"This year, the SCT David Sackett Trial of the Year Committee was honored to review numerous global nominations of clinical trials spanning a wide variety of medical settings including COVID-19, oncology, cardiology, obesity, diabetes, orthopedics, and pregnancy," said Suzanne Dahlberg, PhD, Chair of the SCT David Sackett Trial of the Year Committee. "We are eager for Dr. Tita to present the details of his trial of treatment for mild chronic hypertension during pregnancy, a trial most deserving of this competitive award, and look forward to a lively discussion afterwards."

Nominations for the Trial of the Year are submitted by Society members, investigators, and interested scholars from around the world. The 2022 David Sackett Trial of the Year Committee included: Drs. Andrew Cook (co-chair); Karla Ballman, Jonathan Cook, Manohara Basoor Halasiddappa, Yan Lin, Theodore Lystig, Jessica Overbey, and Sameer Parpia. Dr. David L. Sackett was a dedicated long-time SCT member and a pioneer in evidence-based medicine and champion of clinical trials.

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2021

The TOGETHER Trial: An Adaptive Platform International Trial

Arlington Heights, Ill., April 22, 2022 -- The Society for Clinical Trials (SCT) is pleased to announce that the prestigious David Sackett Trial of the Year Award will be presented to The TOGETHER Trial: An Adaptive Platform International Trial.

The award will be presented on May 16, 2022, as part of SCT's 43rd Annual Meeting, "Informing Public Health Policy with Compelling Evidence," May 15 - 18, 2022 at the Hilton San Diego Bayfront Hotel. Accepting the award and presenting the trial will be Co-Principal Investigators, Drs. Edward J. Mills, Professor, Department of Health Research Methods, Evidence & Impact, Faculty of Health Sciences from McMaster University; and Gilmar Reis, Associate Professor of Medicine, Pontifica Universidade Catolica de Minas Gerais.

The TOGETHER Trial winning nomination is based on two of the trials: Effect of Early Treatment With Hydroxychloroquine or Lopinavir and Ritonavir on Risk of Hospitalization Among Patients With COVID-19; and The TOGETHER Randomized Clinical Trial and Effect of Early Treatment With Fluvoxamine on Risk of Emergency Care and Hospitalization Among Patients with COVID-19.

The overarching objective of this study is to test the hypothesis that repurposed drugs versus placebo effectively prevent worsening of COVID-19 requiring extended emergency room observation or hospitalization among high-risk adults at 28 days post-randomization. This trial is now expanding to South Africa, Pakistan, Rwanda, DRC, and Vietnam.

According to the nomination submitted by Drs. Mills and Reis, the TOGETHER Trial is now the largest placebo-controlled clinical trial for the evaluation of COVID-19 therapeutics in the world. The trial recruited its first patient on June 2, 2020 and to date has enrolled more than 5,000 patients in community-based settings, whose data have contributed to the evaluations of 11 different potentially life-saving therapeutic interventions.

The TOGETHER Trial Consortia consists of representatives from a diverse spectrum of global and national institutions, including academic, professional membership, industry and private sector, multinational, and philanthropic agencies.

"The SCT David Sackett Trial of the Year Committee was delighted to receive an enthusiastic response this year. Global trial nominations ranged from neonatal to adults and settings including Stroke, Surgical Wound Care, Ventilation Sedation, Low Birth Weight, Neonatal Hyperthermia, Addictive Disorder Use Treatment, Covid-19 Treatment, Concomitant Prophylactic Vaccinations, Tuberculosis Treatment, and Research Participation Incentivization," said Ms. Debra Hill, MSN, RN, CCRP; Chair of the SCT Trial of the Year Committee. "I look forward to the in-person SCT Annual Meeting and learning more in depth details of the TOGETHER Trial in addition to anticipating an engaging question and answer session."

Nominations for the Trial of the Year are submitted by Society members, investigators, and interested scholars from around the world. The 2021 Trial of the Year selection committee included: Debra Hill, Chair; Suzanne Dahlberg, Co-Chair; Andrew Cook; Manohara Basoor Halasiddappa; Yan Lin; Theodore Lystig; Jessica Overbey; and Sameer Parpia. Dr. David L. Sackett was a dedicated long-time SCT member and a pioneer in evidence-based medicine and champion of clinical trials.

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2020

The Society for Clinical Trials (SCT) is pleased to announce that the prestigious David Sackett Trial of the Year Award will be presented today to the RECOVERY (Randomized Evaluation of COVID-19 Therapy) trial led by the University of Oxford.

The RECOVERY trial was a large, pragmatic randomized trial for the treatment of hospitalized patients with a suspected or confirmed COVID-19 infection. It was designed and implemented at extraordinary speed in the midst of the COVID-19 pandemic, at a time of great need for effective treatments to reduce mortality among hospitalized patients.

“The RECOVERY trial is well chosen for this year’s award and is presented on the International Clinical Trials Day,” said Dr. Susan Halabi, President of SCT and Professor of Biostatistics and Bioinformatics, Duke University. “The COVID-19 pandemic underscored the importance of responding with agility while still maintaining scientific rigor. What we're learned from the RECOVERY trial is that scientific achievements can be made expeditiously,” Halabi said. “This trial is a superb example of that; the scientific team did not sacrifice science for efficiency, and carefully planned efficiency fostered agility. The RECOVERY trial highlights the immense and positive impact that clinical trials have on the world, especially during the pandemic. Engagement of several thousands of volunteers is truly impressive. Lastly, this trial would serve as a model for efficient design for future clinical trials for all diseases.”

“This year, the Trial of the Year Committee received several nominations for outstanding trials, including those that have arguably had the most profound impact on public health during a pandemic: the COVID-19 vaccination trials,” said Dr. Marc Buyse, Chair of the SCT Trial of the Year Committee. “Whilst all nominated trials would have deserved the award, the vote finally went to RECOVERY not just because of its spectacular speed, efficiency, and pragmatism, but also because this trial will have a lasting impact on how trials should be conducted in all disease areas going forward.

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2019

The Society for Clinical Trials (SCT) is pleased to announce that the prestigious David Sackett Trial of the Year Award for 2019 has been awarded to the Pamoja Tulinde Maisha (PALM ["Together Save Lives"] in the Kiswahili language) trial, an international group of investigators for their work in identifying safe effective therapies for Ebola - a highly deadly hemorrhagic fever virus.

"Amid the current global burden of COVID-19, the PALM trial not only highlights the critical importance of conducting rigorous clinical trials to establish effective therapies but also the necessary interdisciplinary and collaborative resolve to successfully execute clinical trials under urgent circumstances," said Dr. Dean Fergusson, Ottawa Hospital Research Institute, President of SCT.

During the second largest Ebola outbreak declared on August 1st, 2018 in the Democratic Republic of Congo, 2,196 of 3,296 cases (67 percent) died as reported on November 17th, 2019. No known therapeutic countermeasures were licensed at the beginning of this outbreak. Clinical trials evaluating interventions for Ebola are difficult to conduct due to the unpredictable and episodic nature of the disease and the lack of research infrastructure in outbreak locations.

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2018

The Scleroderma: Cyclophosphamide or Transplantation (SCOT) trial is the recipient of the prestigious David Sackett Trial of the Year Award, presented annually by the Society for Clinical Trials (SCT). Dr. Lynette Keyes-Elstein, Principal Statistical Scientist at Rho will accept the award on behalf of the SCOT trial team. She will present the SCOT trial on May 20, 2019 at the Society's 40th Annual Meeting in New Orleans, Louisiana.

Scleroderma is a devastating progressive heterogeneous autoimmune disease that is associated with considerable mortality and morbidity. No FDA-approved therapy is available for patients with scleroderma, and mortality rates have remained constant over the past forty years. In the SCOT trial, adults with severe scleroderma were randomly assigned to undergo myeloablative autologous hematopoietic stem-cell transplantation (AHCT) or to receive cyclophosphamide. AHCT resulted in improvement in the primary end point a global rank composite score incorporating survival, event-free survival (survival without respiratory, renal, or cardiac failure), forced vital capacity, the score on the Disability Index of the Health Assessment Questionnaire, and the modified Rodnan skin score. The American Society for Blood and Marrow Transplantation Task Force now recommends AHCT as the standard of care for patients with severe disease. The SCOT trial was supported by the National Institute of Allergy and infectious Diseases of the National Institutes of Health.

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2017

The Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy (STAMPEDE, NCT00268476) trial and Efficacy and Safety of Voretigene Neparvovec (AAV2-hRPE65v2) in Patients with RPE65-mediated Inherited Retinal Dystrophy (NCT00999609)are co-recipients of the prestigious David Sackett Trial of the Year Award, presented annually by the Society for Clinical Trials.

Matt Sydes, Ph.D., Senior Scientist, Senior Statistician and Deputy Director MRC CTU Hubs for Trials Methodology Research, will accept the award on behalf of the STAMPEDE trial team. Dr. Fan-fan Yu, Sc.D., Senior Statistical Scientist at Statistics Collaborative and Dr. Kathleen Z. Reape, M.D., head of Clinical Research and Development at Spark Therapeutics, Inc. will accept the award on behalf of the Voretigene Neparvovec trial team. The co-recipients presented their trials on May 23, 2018 at the Society's 39th Annual Meeting in Portland, Oregon.

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2016

Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis (ORATORIO, NCT01194570) , a randomized controlled trial, is the 2016 awardee for the prestigious David Sackett Trial of the Year Award, presented annually by the Society for Clinical Trials. Jerry S. Wolinsky, Emeritus Professor in Neurology, The University of Texas Health Science Center at Houston, and the senior investigator on the ORATORIO Trial accepted the award on behalf of the ORATORIO Trial team. Dr. Wolinsky presented the ORATORIO Trial on May 9, 2017 at the Society's 38th Annual Meeting in Liverpool, England.

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2015

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.

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2014

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.

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2013

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.

2012

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

2011

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.

2010

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%.

2009

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)

2008

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).

2007

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).