Meredith G Warshaw1, Vincent J Carey1,2, Elizabeth J McFarland3, Liza Dawson4, Elaine Abrams5, Ann Melvin6, Lee Fairlie7, Hans Spiegel8, Jonathan Jay9, Allison L Agwu10. 1. 1 Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA. 2. 2 Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. 3. 3 Department of Pediatrics, School of Medicine, University of Colorado, Aurora, CO, USA. 4. 4 Basic Sciences Program, Division of AIDS, NIAID/NIH/DHHS, Bethesda, MD, USA. 5. 5 ICAP, Mailman School of Public Health and College of Physicians and Surgeons, Columbia University, New York, NY, USA. 6. 6 Division of Pediatric Infectious Disease, Department of Pediatrics, Seattle Children's Research Institute, University of Washington, Seattle, WA, USA. 7. 7 Wits Reproductive Health and HIV Institute (WRHI), University of the Witwatersrand, Johannesburg, Johannesburg, South Africa. 8. 8 Kelly Government Solutions, Contractor to DAIDS/NIAID/NIH, Rockville, MD, USA. 9. 9 Harvard T.H. Chan School of Public Health, Boston, MA, USA. 10. 10 Division of Pediatric Infectious Diseases, Department of Pediatrics, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.
Abstract
INTRODUCTION: Equipoise is usually discussed as an ethical issue in clinical trials. However, it also has practical implications. BACKGROUND: Clinical equipoise is usually construed to mean uncertainty or disagreement among the expert clinician community. However, an individual physician's sense of equipoise may vary by location, based on the local standard of care or availability of specific treatment options, and these differences can affect providers' willingness to enroll participants into clinical trials. There are also logistical barriers to enrollment in international trials due to prolonged timelines for approvals by government agencies and ethical review boards. CASE STUDY: A multinational clinical trial of bridging strategies for treatment of non-adherent HIV-infected youth, experienced differing perceptions of equipoise due to disparities in availability of treatment options by country. Unfortunately, the countries with most demand for the trial were those where the approval process was most delayed, and the study was closed early due to slow accrual. DISCUSSION: When planning multicenter clinical trials, it is important to take into account heterogeneity among research sites and try to anticipate differences in equipoise and logistical factors between sites, in order to plan to address these issues at the design stage.
INTRODUCTION: Equipoise is usually discussed as an ethical issue in clinical trials. However, it also has practical implications. BACKGROUND: Clinical equipoise is usually construed to mean uncertainty or disagreement among the expert clinician community. However, an individual physician's sense of equipoise may vary by location, based on the local standard of care or availability of specific treatment options, and these differences can affect providers' willingness to enroll participants into clinical trials. There are also logistical barriers to enrollment in international trials due to prolonged timelines for approvals by government agencies and ethical review boards. CASE STUDY: A multinational clinical trial of bridging strategies for treatment of non-adherent HIV-infected youth, experienced differing perceptions of equipoise due to disparities in availability of treatment options by country. Unfortunately, the countries with most demand for the trial were those where the approval process was most delayed, and the study was closed early due to slow accrual. DISCUSSION: When planning multicenter clinical trials, it is important to take into account heterogeneity among research sites and try to anticipate differences in equipoise and logistical factors between sites, in order to plan to address these issues at the design stage.
Entities:
Keywords:
Equipoise; HIV/AIDS; enrollment; international clinical trials; logistics
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