13th Annual Trial of the Year Award Recipient
Selected by the Society for Clinical Trials as the 2019 Trial of the Year
Pamoja Tulinde Maisha (PALM ["Together Save Lives"] in the Kiswahili language) trial
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.
The PALM trial evaluated four investigational therapies for Ebola during the outbreak in the Democratic Republic of the Congo. Patients of any age who had a positive result for Ebola virus were enrolled. All patients received standard care and were randomly assigned in a 1:1:1:1 ratio to one of four experimental drugs: intravenous administration of the triple monoclonal antibody ZMapp (the control group), the antiviral agent remdesivir, the single monoclonal antibody MAb114, or the triple monoclonal antibody REGN-EB3. On August 9th, 2019, an independent Data and Safety Monitoring Board recommended discontinuing ZMapp and Remdesivir because 28-day mortality rates in MAb114 and REGN-EB3 were substantially lower. The effective therapies (MAb114 and REGN-EB3) were immediately adopted in the field.
"With results that were published within one year of study start, the PALM trial demonstrated that scientifically and ethically sound clinical research can be conducted during disease outbreaks and can help inform the outbreak response," said Dr. Scott Evans, George Washington University, Chair of the SCT Trial of the Year Committee.
The PALM trial was jointly led by the National Institute for Biomedical Research (INRB/DRC) and the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (NIAID/NIH) as part of an international research consortium coordinated by the World Health Organization (WHO). The consortium included additional support from the Alliance for International Medical Assistance (ALIMA), Doctors without Borders (Médecins Sans Frontières, MSF) and the International Medical Corps (IMC). Pharmaceutical partners included Gilead Sciences Inc, Mapp Biopharmaceutical Inc, Regeneron Pharmaceuticals and Ridgeback Biotherapeutics. The trial was published in the New England Journal of Medicine (DOI: 10.1056/NEJMoa1910993).
The SCT will be holding a special webinar on International Clinical Trials Day, May 20th, 2020 to recognize the PALM trial and gain insights into the trial conception and execution. Key PALM trialists will include Professor Jean-Jacques Muyembe and Dr. Placide Mbala from the Institut National pour la Recherche Biomedicale in the Democratic Republic of the Congo; Dr. Lori Dodd from the National Institute of Allergy and Infectious Diseases (NIAID); and Dr. Olivier Tshiani from Leidos Biomedical Research, Inc. (LBR). Discussion will also include how findings and knowledge from PALM can support COVID response efforts. Of note, one of the therapies in the PALM trial, remdesivir, is being studied extensively for treatment of coronavirus infection.
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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.
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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).