Implementation of the exception from informed consent regulations in a large multicenter emergency clinical trials network: the RAMPART experience
Robert Silbergleit, Michelle H Biros, Deneil Harney, Neal Dickert, Jill Baren, NETT Investigators, William G Barsan, Daniel Lowenstein, Lewis Morgenstern, Arthur Pancioli, Robert Silbergleit, Valerie Stevenson, Deneil Harney, Donna Harsh, Kay Vonderschmidt, Erin Zaleski, Yuko Palesch, Valerie Durkalski, Catherine Dillon, Robin Conwit, Scott Janis, David Wright, Gerald Beltran, Andrea McDougal, Matthew Bitner, Harriet Howlett-Smith, Rachel Barnhard, Chris Lewandowski, Taher Vohra, Anna Baker, Deen Creech, Gregory Flynn, Paula Crouse, Tom Aufderheide, Joseph Brandt, Riccardo Colella, Joanna Delap, Michel Torbey, Jennifer Noldin, Erin Brandenburg, Stephan Mayer, Neal Flomenbaum, Cristina Falo, Chirag Surti, Heidi Cordi, Robert Lowe, Craig Warden, Rachel Stone, James Quinn, Stephanie Casal, Peter Dsouza, Matt Hall, Nina Gentile, Brent Freeman, Stacey Cleary, Christopher Vates, Alvin Wang, Kurt Denninghoff, Daniel Spaite, Bruce Barnhart, Willie Haro, Claude Hemphill, Michele Meeker, Jeany Duncan, Karl Sporer, Art Pancioli, Hamilton Schwartz, Irene Ewing, Kay Vonderschmidt, Jason McMullan, Erin Grise, Roger Humphries, Linda Dechtenberg, Christofer Sweat, Robert Hendricks, Barney Stern, Tricia Ting, Greg Krauss, Virginia Ganley, Susan Rice, Michelle Stevens, Greg Valcourt, Michelle Biros, Corey Sargent, Kathleen Miller, Jill Baren, R Daniel Bledsoe, Katie Lamond, Barbie Stahlman, Elizabeth Jones, T J Milling, Misty Ottman, Ben King, Louis Gonzales, Jeffrey Brockman, Gonnie Richter, David Anderson, Joseph Ornato, Sallie Noe, Alan Payne, Robert Welch, LynnMarie Mango, Jenny Atas, Robert Silbergleit, Michelle H Biros, Deneil Harney, Neal Dickert, Jill Baren, NETT Investigators, William G Barsan, Daniel Lowenstein, Lewis Morgenstern, Arthur Pancioli, Robert Silbergleit, Valerie Stevenson, Deneil Harney, Donna Harsh, Kay Vonderschmidt, Erin Zaleski, Yuko Palesch, Valerie Durkalski, Catherine Dillon, Robin Conwit, Scott Janis, David Wright, Gerald Beltran, Andrea McDougal, Matthew Bitner, Harriet Howlett-Smith, Rachel Barnhard, Chris Lewandowski, Taher Vohra, Anna Baker, Deen Creech, Gregory Flynn, Paula Crouse, Tom Aufderheide, Joseph Brandt, Riccardo Colella, Joanna Delap, Michel Torbey, Jennifer Noldin, Erin Brandenburg, Stephan Mayer, Neal Flomenbaum, Cristina Falo, Chirag Surti, Heidi Cordi, Robert Lowe, Craig Warden, Rachel Stone, James Quinn, Stephanie Casal, Peter Dsouza, Matt Hall, Nina Gentile, Brent Freeman, Stacey Cleary, Christopher Vates, Alvin Wang, Kurt Denninghoff, Daniel Spaite, Bruce Barnhart, Willie Haro, Claude Hemphill, Michele Meeker, Jeany Duncan, Karl Sporer, Art Pancioli, Hamilton Schwartz, Irene Ewing, Kay Vonderschmidt, Jason McMullan, Erin Grise, Roger Humphries, Linda Dechtenberg, Christofer Sweat, Robert Hendricks, Barney Stern, Tricia Ting, Greg Krauss, Virginia Ganley, Susan Rice, Michelle Stevens, Greg Valcourt, Michelle Biros, Corey Sargent, Kathleen Miller, Jill Baren, R Daniel Bledsoe, Katie Lamond, Barbie Stahlman, Elizabeth Jones, T J Milling, Misty Ottman, Ben King, Louis Gonzales, Jeffrey Brockman, Gonnie Richter, David Anderson, Joseph Ornato, Sallie Noe, Alan Payne, Robert Welch, LynnMarie Mango, Jenny Atas
Abstract
Clinical trials investigating therapies for acutely and critically ill and injured patients in the earliest phases of treatment often can only be performed under regulations allowing for exception from informed consent (EFIC) for emergency research. Implementation of these regulations in multicenter clinical trials involves special challenges and opportunities. The Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART), the first EFIC trial conducted by the Neurological Emergencies Treatment Trials (NETT) network, combined centralized resources and coordination with retention of local control and flexibility to facilitate compliance with the EFIC regulations. Specific methods used by the NETT included common tools for community consultation and public disclosure, sharing of experiences and knowledge, and reporting of aggregate results. Tracking of community consultation and public disclosure activities and feedback facilitates empirical research on EFIC methods in the network and supports quality improvements for future NETT trials. The NETT model used in RAMPART demonstrates how EFIC may be effectively performed in established clinical trial networks.
Trial registration: ClinicalTrials.gov NCT00809146.
© 2012 by the Society for Academic Emergency Medicine.
Source: PubMed