The Antithrombotic Trials Leadership and Steering (ATLAS) Group is an adult-focused, multinational, multidisciplinary, multi-institutional collaborative group of hematology, cardiology, and antithrombotics experts with extensive clinical trial experience who are faculty at leading academic institutions.  ATLAS leads an ARO-CRO (academic research – clinical research organization) model and works in partnership with the Colorado Prevention Center (CPC) Clinical Research, an ARO affiliated with the University of Colorado, which organizes ATLAS member leadership and participation in trial committees. Established in 2009, it has remained active in providing academic thought leadership and engagement in trial design, oversight committees and associated publications in the antithrombotic field, with particular emphasis in adult indications (including venous thromboembolism treatment and prevention, stroke prevention in atrial fibrillation, and prevention of thrombotic/occlusive events in peripheral arterial disease.

The ATLAS Group provides leadership for a variety of activities related to cardiovascular, antithrombotic and hematological clinical trials.  The Group offers highly engaged expertise in protocol design, clinical trial development and execution, implementation of quality programs for outcome assessments, data safety monitoring, independent interpretation of study findings, and leadership in presentations and publications of trial results.

With a diversity and depth of experience, and with a variety of opinions built into the ATLAS structure, multiple options can be readily explored to find the best possible course of action for each study or clinical indication.  Collaboration and inclusiveness are core philosophies and partners are not contractually bound to rely only on or work exclusively with ATLAS experts and are free to seek outside opinions.  The inclusion of ATLAS Group members can enable multiple specialty representation at regulatory meetings without any inherent bias and provide fluid interactions with FDA/regulatory bodies to enhance communication and fast resolution of any problems.  The ATLAS Group has a proven history of productivity, collaboration, and strong partnership.  The result is a track record of exceptional performance and teamwork.

The partnership of a multi-institutional, multidisciplinary academic thought leadership group of trialists with a non‑profit Academic Research Organization was described in 2010 for the ARO CPC Clinical Research (CPC) and the ATLAS Group (Goldenberg NA et al., Improving academic leadership and oversight in large industry-sponsored clinical trials: the ARO-CRO model. Blood 2010).  ATLAS partners with CPC to take advantage of CPC’s distinguishing strengths as an ARO: including  management of independent trial oversight committees (e.g., Executive, Steering, and Data and Safety Monitoring), end point adjudication, imaging and biomarker core labs, endpoint quality assurance training and monitoring, and independent validation of statistical analyses, as warranted. CPC has a long track record of trial leadership and management experience in vascular disease and antithrombotic agents, and CPC physician- and methodology-leaders also bring to the ATLAS partnership additional regulatory experience and expertise, to assist Sponsors and ATLAS colleagues with regulatory agencies interactions. In this way, CPC as an ARO complements and augments the functions performed by a CRO contracted by an industry Sponsor, or the industry Sponsor itself. CPC also performs a key function in establishing and maintaining consulting agreements with each of the ATLAS members, and in executing master consulting agreements and master confidentiality/non-disclosure agreements with Sponsors on behalf of all ATLAS members, including invoicing Sponsors and processing payments received from Sponsors for activities performed by ATLAS members. ATLAS is intended to represent a ‘one stop shop’ for industry partners providing harmonized advice from a broad panel of experts. Moreover, the partnership of the ATLAS Group with CPC allows the academic thought leadership group to engage more efficiently in program/trial design and trial oversight, as well as strategic planning across multiple drug development programs.

With the formation of the Pedi-ATLAS group, a deliberate “twinning” was established with the adult-focused ATLAS group to provide infant-to-elderly development program expertise and coordination for antithrombotic trials. Furthermore, two of the founding members of Pedi-ATLAS, Drs. Goldenberg and Bonaca, are also members of the ATLAS Group, and convene the two groups in combined meetings on both a standing semi-annual basis and in interim ad hoc meetings as needs arise.

Marc Bonaca

Marc P. Bonaca, MD, MPH

Neil A. Goldenberg headshot 2022a

Neil Goldenberg, MD, PhD

Dr.Berkowitz_2022-14_ATLAS

Scott D. Berkowitz, MD, FACC, FAHA

Cutler

Dr. Neal Cutler

Kessler

Dr. Craig Kessler

Mount Sinai - Portrait of Dr. Halperin

Dr. Jonathan L. Halperin

Schulman

Sam Schulman

Spyropoulos

Alex C. Spyropoulos, MD, FACP, FCCP, FRCPC

Steg

P. Gabriel Steg, MD, FESC, FACC

Weitz

Jeffrey I. Weitz, MD, FRCPC, FACP, FRSC, FACC, FESC, FCAHS, FAHA