Session – Digital Health and Healthcare
Future of Clinical Trials
Department of Emergency Medicine
Harvard Medical School
Brigham and Women’s Hospital, Boston, MA 02115
Brigham and Women’s Hospital, Department of Emergency Medicine, 75 Francis Street, Boston, MA 02115
Dr. Hou is an emergency physician and critical care specialist practicing in both the emergency department (ED) and the surgical intensive care unit (ICU). His clinical research interests consist of patient care improvement processes for critically ill ED patients being admitted to the ICUs, sepsis, acute respiratory distress syndrome (ARDS), and COVID-19.
Since 2008 from the ED, he was Site-PI for the “Protocolized Care for Early Septic Shock” (ProCESS) trial to evaluate the role of protocolized, quantitative resuscitation treatments in the management of sepsis and septic shock and co-authored “A Randomized Trial of Protocol-Based Care for Early Septic Shock” in New England Journal of Medicine (NEJM). Additionally, he was the Site-PI for three NIH-sponsored ProCESS ancillary studies evaluating the microcirculation and the long-term outcomes of acute kidney injury and host immune response. Furthermore, he was the Site-PI for NIH-sponsored Procalcitonin Antibiotic Consensus Trial (ProACT) and co-authored the NEJM article “Procalcitonin-Guided Use of Antibiotics for Lower Respiratory Tract Infection”.
Since 2009 from the surgical ICU, he was the Site-PI for the US Critical Illness and Injury Trial Group Lung Injury Prevention Study, which derived and validated the Lung Injury Prediction Score in patients at risk for ARDS. In 2014, he became the Co-Lead Investigator for the NIH NHLBI Acute Lung Injury Group of New England Clinical Center and a Steering Committee member of the NIH NHLBI Prevention and Early Treatment of Acute Lung injury (PETAL) Network. Since its inception, he was the Site-PI for the PETAL’s Reevaluation Of Systemic Early Neuromuscular Blockade (ROSE) trial and co-authored the NEJM article “Early Neuromuscular Blockade in the Acute Respiratory Distress Syndrome”. In addition, he was the Site-PI for the NIH-sponsored ancillary study to the ROSE trial called PRIMROSE and the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS). He was the Site-PI for the Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease (ORCHID) trial, which was halted by the Data Safety Monitoring Board that found neither benefit nor harm. Recently, he was a Site-PI and co-authored a Journal of American Medical Association article “Effect of Ascorbic Acid, Corticosteroids, and Thiamine on Organ Injury in Septic Shock: The ACTS Randomized Clinical Trial”.
Currently, he is the site-PI for NHLBI/Mesoblast-sponsored “Network for Cardiothoracic Surgical Investigations in Cardiovascular Medicine: Mesenchymal Stem Cells for the Treatment of Moderate to Severe COVID-19 Acute Respiratory Distress Syndrome Study”, Novartis sponsored “A Phase 2, randomized, placebo-controlled, participant and investigator blinded, multi-center study to assess efficacy and safety of MAS825 for the treatment of SARS-CoV-2 infected patients with COVID-19 pneumonia and impaired respiratory function”, Kinevant Sciences sponsored “A Multi-Center, Adaptive, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to Coronavirus Disease 2019”, CalciMedica sponsored “A Randomized Double Blind, Placebo-Controlled Study of Auxora for the Treatment of Severe COVID-19 Pneumonia”, and Apeiron Biologic sponsored “Recombinant human angiotensin-converting enzyme 2 as a treatment for patients with COVID-19”
Currently, he is a core member of the hospital’s Sepsis Task Force and COVID-19 protocol committee. He is the Research Director for the Brigham and Women’s Hospital Division of Emergency Critical Care Medicine co-leads the Brigham Critical Care Collaborative and Consortium.
He is currently the New England Chapter President of North American Taiwanese Medical Association (NATMA).
Along with clinical medicine, clinical trials in medicine has undergone some major transformations due to the COVID-19 pandemic. With the mandate of social distancing, an exponential increase in the use of telemedicine has been implemented to care for patients. Similarly, telehealth has been implemented and being used for research facilitation, including screening, recruitment, informed consent, data collection, follow-up, and reducing attrition and increasing engagement. The objective of this presentation is to describe how clinical trials were carried out in the past, and with telehealth, how they are being carried out in the present, and will be like in the future with virtual clinical trials.