D Patrone1. 1. Philosophy Department, Union Graduate College-Mt Sinai School of Medicine Bioethics Program, Union College, 80 Nott Terrace, Schenectady, NY 13847, USA. dpatrone@gmail.com
Abstract
BACKGROUND AND AIM: The full disclosure of all locations at which research is conducted is an important requirement of clinical trial registration. Yet, little is known about how well researchers and sponsors disclose this information in their registrations. The aim of this study is to examine the adequacy of study location disclosure on http://ClinicalTrials.gov/ for recent USA-sponsored research in the Russian Federation. METHODS AND RESULTS: Information from advertisements for clinical research participation opportunities in Russia was compared with that in the corresponding trial registration in http://ClinicalTrials.gov/. Of 218 USA-sponsored trials advertised to Russian patients and physicians, nearly one-third did not disclose Russia as a study location in the registration. Longer trials were more likely to specify Russia as a study location. CONCLUSION: This study found that recent USA-sponsored clinical trials advertised to patients and physicians in the Russian Federation often do not specify Russia as a study location in their registrations on http://ClinicalTrials.gov/. The failure to fully disclose the locations at which research takes place undermines patients' ability to access information about potentially beneficial research opportunities, limits access to information, which may be important for identifying or avoiding ethically questionable practices, and may frustrate the ability to interpret the results of research.
BACKGROUND AND AIM: The full disclosure of all locations at which research is conducted is an important requirement of clinical trial registration. Yet, little is known about how well researchers and sponsors disclose this information in their registrations. The aim of this study is to examine the adequacy of study location disclosure on http://ClinicalTrials.gov/ for recent USA-sponsored research in the Russian Federation. METHODS AND RESULTS: Information from advertisements for clinical research participation opportunities in Russia was compared with that in the corresponding trial registration in http://ClinicalTrials.gov/. Of 218 USA-sponsored trials advertised to Russian patients and physicians, nearly one-third did not disclose Russia as a study location in the registration. Longer trials were more likely to specify Russia as a study location. CONCLUSION: This study found that recent USA-sponsored clinical trials advertised to patients and physicians in the Russian Federation often do not specify Russia as a study location in their registrations on http://ClinicalTrials.gov/. The failure to fully disclose the locations at which research takes place undermines patients' ability to access information about potentially beneficial research opportunities, limits access to information, which may be important for identifying or avoiding ethically questionable practices, and may frustrate the ability to interpret the results of research.