BACKGROUND: The Final Rule regulations were developed to allow exception from informed consent (EFIC) to enable clinical trial research in emergency settings where major barriers exist for informed consent. There is little known evidence of the effect of the Final Rule in minority enrollment in clinical trials, particularly in traumatic brain injury (TBI) trials. A clinical trial funded by the National Institute of Neurological Disorders and Stroke was conducted to study the effects of erythropoietin on cerebral vascular dysfunction and anemia in subjects with TBI. There were periods of time when EFIC was and was not available for enrollment into the study. PURPOSE: To explore the effect of EFIC availability on TBI trial enrollment of minority versus non-minority subjects. METHODS: Minority status of screened (n = 289) and enrolled (n = 191) TBI subjects was determined for this study. We tested for the presence of a minority and EFIC availability interaction in a multiple logistic regression model after controlling for EFIC and minority group main effects and other covariates. RESULTS: An interaction between the availability of EFIC minority and non-minority enrollment was not detected (odds ratio = 1.22; 95% confidence interval (CI) = 0.29-5.16). LIMITATIONS: Our study was conducted at a single site, and the CI for the EFIC and minority interaction term was wide. Therefore, a small interaction effect cannot be ruled out. CONCLUSION: EFIC increased the odds of being enrolled regardless of minority status.
BACKGROUND: The Final Rule regulations were developed to allow exception from informed consent (EFIC) to enable clinical trial research in emergency settings where major barriers exist for informed consent. There is little known evidence of the effect of the Final Rule in minority enrollment in clinical trials, particularly in traumatic brain injury (TBI) trials. A clinical trial funded by the National Institute of Neurological Disorders and Stroke was conducted to study the effects of erythropoietin on cerebral vascular dysfunction and anemia in subjects with TBI. There were periods of time when EFIC was and was not available for enrollment into the study. PURPOSE: To explore the effect of EFIC availability on TBI trial enrollment of minority versus non-minority subjects. METHODS: Minority status of screened (n = 289) and enrolled (n = 191) TBI subjects was determined for this study. We tested for the presence of a minority and EFIC availability interaction in a multiple logistic regression model after controlling for EFIC and minority group main effects and other covariates. RESULTS: An interaction between the availability of EFIC minority and non-minority enrollment was not detected (odds ratio = 1.22; 95% confidence interval (CI) = 0.29-5.16). LIMITATIONS: Our study was conducted at a single site, and the CI for the EFIC and minority interaction term was wide. Therefore, a small interaction effect cannot be ruled out. CONCLUSION: EFIC increased the odds of being enrolled regardless of minority status.
Authors: Morris A Blajchman; Jeffrey L Carson; John W Eikelboom; Nancy M Heddle; Jacques Lacroix; Michael S Lauer; Richard Platt; Barbara Tilley; Darrell Triulzi; Andrew J Vickers; Salim Yusuf; Simone Glynn; Traci Heath Mondoro; Elizabeth Wagner Journal: Transfusion Date: 2012-04-09 Impact factor: 3.157
Authors: Mark Sherer; Todd G Nick; Angelle M Sander; Tessa Hart; Robin Hanks; Mitchell Rosenthal; Walter M High; Stuart A Yablon Journal: J Head Trauma Rehabil Date: 2003 Sep-Oct Impact factor: 2.710
Authors: Terri A Schmidt; David Salo; Jason A Hughes; Jean T Abbott; Joel M Geiderman; Catherine X Johnson; Katie B McClure; Mary Pat McKay; Junaid A Razzak; Raquel M Schears; Robert C Solomon Journal: Acad Emerg Med Date: 2004-10 Impact factor: 3.451
Authors: Claudia S Robertson; H Julia Hannay; José-Miguel Yamal; Shankar Gopinath; J Clay Goodman; Barbara C Tilley; Athena Baldwin; Lucia Rivera Lara; Hector Saucedo-Crespo; Osama Ahmed; Santhosh Sadasivan; Luciano Ponce; Jovanny Cruz-Navarro; Hazem Shahin; Imoigele P Aisiku; Pratik Doshi; Alex Valadka; Leslie Neipert; Jace M Waguspack; M Laura Rubin; Julia S Benoit; Paul Swank Journal: JAMA Date: 2014-07-02 Impact factor: 56.272