PURPOSE

The Society for Clinical Trials, created in 1978, is an international professional organization dedicated to the development and dissemination of knowledge about the design and conduct of clinical trials and related health care research methodologies.

OBJECTIVES

• To provide a forum for discussion of biometrical, computational, philosophical, ethical, and procedural issues arising from the design, organization, operation, analysis, and reporting of clinical trials.
• To promote methodologic research and the application of sound scientific methods of intervention trials.
• To facilitate communication among the various disciplines involved in the conduct of clinical trials.
• To educate and inform health care researchers about the design, operation, and analysis of clinical trials.
• To promote a better understanding by the general public of the importance of randomized clinical trials in evaluating interventions for the prevention, diagnosis, and treatment of disease.

Phone: (410) 433-4722 Fax: (410) 435-8631 Postal Address: 600 Wyndhurst Avenue - Baltimore, Maryland 21210¹⁾

Barbara S. Hawkins, PhD President The Johns Hopkins University Baltimore, Maryland

Barry R. Davis, MD, PhD President-Elect University of Texas Houston, Texas

Stuart Pocock, PhD Past-President London School of Hygiene and Tropical Medicine London, England

Joel Verter, PhD Secretary The George Washington University Rockville, Maryland

Christopher G. Donhauser, MBA Treasurer Maryland Medical Research Institute Baltimore, Maryland

Mary Burke Coordinator 600 Wyndhurst Avenue Baltimore, Maryland

William Blackwelder, PhD (1999) National Institute of Allergy and Infectious Diseases Bethesda, Maryland

Brent Blumenstein, PhD (2001) American College of Surgeons Chicago, Illinois

Marc Buyse, MBA, ScD (2002) International Institute for Drug Development Brussels, Belgium

Joyce Cramer, BS (1999) VA Medical Center West Haven, Connecticut

Kay Dickersin, PhD (2001) Brown University Providence, Rhode Island

Jennifer Gassman, PhD (2001) The Cleveland Clinic Foundation Cleveland, Ohio

Stephen George, PhD (1998) Duke University Medical Center Durham, North Carolina

Theodore Karrison, PhD (2002) University of Chicago Chicago, Illinois

Frances LoPresti, MS (2000) Maryland Medical Research Institute Baltimore, Maryland

Susan Margitic ( 2002) Bowman-Gray School of Medicine Winston-Salem, North Carolina

Joyce Niland, PhD (2000) City of Hope Medical Center Duarte, California

Joseph Pater, MD (2000) Queens University Kingston, Ontario, Canada ²⁾

Each year the Society for Clinical Trials and Project ImpACT presents an award to the randomized clinical trial published 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 SCT/ImpACT Trial of the Year 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).

We are now accepting nominations for the outstanding Trial of the Year published in 2009. The deadline for nominations is January 31, 2010, and the award will be presented at our annual meeting in Baltimore. Please click here to nominate a trial you think best meets our standards. ³⁾

Society for Clinical Trials Summary of the Board Approved 3-Year Strategic Plan - July 2018 The Society’s Executive Committee (EC) and Board created a Strategic Planning Committee in early 2018 that was charged with proposing a 3-year strategic plan for the Society. The proposal was reviewed and approved by both the EC and Board Members at the Board Meeting held during the annual SCT meeting in Portland, May 2018. The following is a summary of the approved plan.

The Society for Clinical Trials is a scientific, educational, and charitable organization whose mission is to work internationally to advance human health through advocating the use of clinical trials, leading the development and dissemination of optimal methods and practices in clinical trials, and educating and developing clinical trial professionals. We accomplish this mission through our annual scientific meeting, which includes invited and contributed sessions, poster presentations, and educational short courses and workshops; our highly regarded journal Clinical Trials; our ongoing webinar series; and our many outreach activities. We strive to be a multidisciplinary society consisting of clinical investigators, biostatisticians, project managers, IT specialists, clinical research associates and other specialists engaged in the design, conduct, and analysis of clinical trials.

Sustainability of the Society: Although we desire to be a multidisciplinary society, there is a growing concern that we are not attracting and retaining members beyond our statistical audience. The key to sustainability and long-term success of the Society is to attract a multidisciplinary membership by providing an attractive and recognized venue for information and debate on all aspects of clinical trial methodology and conduct.

Leadership Development within the Society: Closely tied to the goal of sustainability of the Society is the assurance of continued participation and leadership within the Society. The Society must devote sufficient time and resources to developing the next generation of Society leadership.

Sustainability: Pursue Diversity in Membership The EC and Board will actively work with the SCT Membership, Program and Education Committees to pursue initiatives that will expand the diversity of membership of the Society. The ultimate goal is to enhance outreach programs to increase membership generally, but more importantly to increase disciplinary diversity and re-build the representation of key disciplines that have been better represented in the past.

Leadership Development: Nurturing Society Leadership The EC will create an ad hoc Leadership Fostering Committee. The primary charge of this committee is to identify early and mid-career individuals involved in the clinical trials enterprise who have the energy and potential for taking leadership roles in the Society, and to facilitate their appointment to meaningful roles within the Society, either on one of our many committees or in important ad hoc activities.

Updates to our members on the different society initiatives to address the strategic plan will be communicated through the newsletters. Members interested in participating in these initiatives are welcome to contact Kevin Bragaw, SCT Executive Director at info@sctweb.org ⁴⁾

15th Annual Trial of the Year Award Recipient Selected by the Society for Clinical Trials as the 2021 Trial of the Year 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. ⁵⁾

Full Press Release ⁶⁾

Janssen Research & Development - Johnson & Johnson

Our mission is to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. We believe that challenging something is the best way to change it.

Bristol Myers Squibb

Bristol Myers Squibb is a leading global biopharma company focused on discovering, developing and delivering innovative medicines for patients with serious diseases in areas including oncology, hematology, immunology, cardiovascular, fibrosis and neuroscience. Our employees work every day to transform patients’ lives through science.

Frontier Science Foundation

Frontier Science Foundation is a not-for-profit research organization dedicated to the improvement of data management and statistical quality in clinical trials and medical research.

GW Biostatistics Center

The GW Biostatistics Center has a 47 year history of leadership in practice-changing clinical trials and biostatistical methodology research. Center research has been recognized in reports to the US President and Congress and resulted in over 60 NEJM publications.

Merck

For more than a century, MSD has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, MSD continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

Amgen

Amgen strives to serve patients by transforming the promise of science and biotechnology into therapies that have the power to restore health or save lives. In everything we do, we aim to fulfill our mission to serve patients. And every step of the way, we are guided by the values that define us.

Berry Consultants

Berry Consultants is a statistical consulting company specializing in innovative clinical trial design, Bayesian analysis, adaptive clinical trial execution, and simulation software solutions for the pharmaceutical and medical device industry.

Otsuka Pharmaceutical Co., Ltd

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” In the U.S., Otsuka America Pharmaceutical, Inc. manufactures, markets, and distributes pharmaceuticals and medical devices in the challenging areas of neuroscience, nephrology, and digital health solutions.

University of Wisconsin DCC

The Data Coordinating Center (DCC) is a component of the Clinical Trials Program in the Department of Biostatistics and Medical Informatics at the UW School of Medicine and Public Health. The DCC supports investigator-initiated NIH or industry-sponsored RCTs. We provide expertise in planning, conduct, monitoring, and analysis of clinical trials.

Vertex

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) - a rare, life-threatening genetic disease - and has several ongoing clinical and research programs in CF. ⁷⁾

The TOGETHER Trial's Missing Arms: Doxazosin, and Low-Dose Ivermectin Alexandros Marinos - Substack September 18, 2022

Andrew Hill, in his paper titled “Ivermectin for COVID-19: Addressing Potential Bias and Medical Fraud“, concludes that clinical trials must urgently up their game:

With cases of potential medical fraud now identified, it is essential that access to patient-level databases be provided. If authors fail to provide these data, the study should be considered with a higher index of suspicion. Additionally, it should be mandatory that all registered trials report their findings. We understand that these are substantial changes to established procedures. However, the failure to recognize the potentially fraudulent studies, which led to multiple meta-analyses suggesting significant benefits of ivermectin for COVID-19, indicates that the tools currently used to evaluate the quality of clinical trials are insufficient. These events warrant our stringent recommendations.

Taking his warnings seriously, I thought perhaps the best place to start would be the winner of the “Trial of the Year,” as awarded by the Society for Clinical Trials. I’m talking about none other than the TOGETHER Trial ⁸⁾