title: Data Quality Monitoring in Clinical Trials: Has It Been Worth It? An Evaluation and Prediction of the Future by All Stakeholders.
abstract: This paper summarizes the results of the CNS Summit Data Quality Monitoring Workgroup analysis of current data quality monitoring techniques used in central nervous system (CNS) clinical trials. Based on audience polls conducted at the CNS Summit 2014, the panel determined that current techniques used to monitor data and quality in clinical trials are broad, uncontrolled, and lack independent verification. The majority of those polled endorse the value of monitoring data. Case examples of current data quality methodology are presented and discussed. Perspectives of pharmaceutical companies and trial sites regarding data quality monitoring are presented. Potential future developments in CNS data quality monitoring are described. Increased utilization of biomarkers as objective outcomes and for patient selection is considered to be the most impactful development in data quality monitoring over the next 10 years. Additional future outcome measures and patient selection approaches are discussed.
authors.affiliation: Dr. Daniel is with Bracket Global, Washington, DC; Dr. Kalali is with Quintiles, San Diego, California; Mr. West is with Innovum Technologies, Las Vegas, Nevada (Mr. West was with ePharma Solutions, Plymouth Meeting, Pennsylvania, during the preparation of this executive summary); Dr. Walling is with Collaborative Neuroscience Network, Long Beach, California; Dr. Hilt is with Forum Pharmaceuticals, Waltham, Massachusetts; Dr. Engelhardt is with Cronos, Lambertville, New Jersey; Dr. Alphs is with Janssen Scientific Affairs, LLC, Titusville, New Jersey; Dr, Loebel is with Sunovion, Fort Lee, New Jersey; Dr. Vanover is with Intra-Cellular Therapies, New York, New York; Dr. Atkinson is with Finger Lakes Clinical Research, Rochester, New York; Dr. Opler is with ProPhase LLC, New York, New York; Dr. Sachs is with Bracket Global, Lexington, Massachusetts; Dr. Nations is with INC Research, Austin, Texas; and Dr. Brady is with inVentiv Health Clinical, Princeton, New Jersey.
authors.forename: David
authors.initials: D
authors.lastname: Daniel
authors.affiliation: Dr. Daniel is with Bracket Global, Washington, DC; Dr. Kalali is with Quintiles, San Diego, California; Mr. West is with Innovum Technologies, Las Vegas, Nevada (Mr. West was with ePharma Solutions, Plymouth Meeting, Pennsylvania, during the preparation of this executive summary); Dr. Walling is with Collaborative Neuroscience Network, Long Beach, California; Dr. Hilt is with Forum Pharmaceuticals, Waltham, Massachusetts; Dr. Engelhardt is with Cronos, Lambertville, New Jersey; Dr. Alphs is with Janssen Scientific Affairs, LLC, Titusville, New Jersey; Dr, Loebel is with Sunovion, Fort Lee, New Jersey; Dr. Vanover is with Intra-Cellular Therapies, New York, New York; Dr. Atkinson is with Finger Lakes Clinical Research, Rochester, New York; Dr. Opler is with ProPhase LLC, New York, New York; Dr. Sachs is with Bracket Global, Lexington, Massachusetts; Dr. Nations is with INC Research, Austin, Texas; and Dr. Brady is with inVentiv Health Clinical, Princeton, New Jersey.
authors.forename: Amir
authors.initials: A
authors.lastname: Kalali
authors.affiliation: Dr. Daniel is with Bracket Global, Washington, DC; Dr. Kalali is with Quintiles, San Diego, California; Mr. West is with Innovum Technologies, Las Vegas, Nevada (Mr. West was with ePharma Solutions, Plymouth Meeting, Pennsylvania, during the preparation of this executive summary); Dr. Walling is with Collaborative Neuroscience Network, Long Beach, California; Dr. Hilt is with Forum Pharmaceuticals, Waltham, Massachusetts; Dr. Engelhardt is with Cronos, Lambertville, New Jersey; Dr. Alphs is with Janssen Scientific Affairs, LLC, Titusville, New Jersey; Dr, Loebel is with Sunovion, Fort Lee, New Jersey; Dr. Vanover is with Intra-Cellular Therapies, New York, New York; Dr. Atkinson is with Finger Lakes Clinical Research, Rochester, New York; Dr. Opler is with ProPhase LLC, New York, New York; Dr. Sachs is with Bracket Global, Lexington, Massachusetts; Dr. Nations is with INC Research, Austin, Texas; and Dr. Brady is with inVentiv Health Clinical, Princeton, New Jersey.
authors.forename: Mark
authors.initials: M
authors.lastname: West
authors.affiliation: Dr. Daniel is with Bracket Global, Washington, DC; Dr. Kalali is with Quintiles, San Diego, California; Mr. West is with Innovum Technologies, Las Vegas, Nevada (Mr. West was with ePharma Solutions, Plymouth Meeting, Pennsylvania, during the preparation of this executive summary); Dr. Walling is with Collaborative Neuroscience Network, Long Beach, California; Dr. Hilt is with Forum Pharmaceuticals, Waltham, Massachusetts; Dr. Engelhardt is with Cronos, Lambertville, New Jersey; Dr. Alphs is with Janssen Scientific Affairs, LLC, Titusville, New Jersey; Dr, Loebel is with Sunovion, Fort Lee, New Jersey; Dr. Vanover is with Intra-Cellular Therapies, New York, New York; Dr. Atkinson is with Finger Lakes Clinical Research, Rochester, New York; Dr. Opler is with ProPhase LLC, New York, New York; Dr. Sachs is with Bracket Global, Lexington, Massachusetts; Dr. Nations is with INC Research, Austin, Texas; and Dr. Brady is with inVentiv Health Clinical, Princeton, New Jersey.
authors.forename: David
authors.initials: D
authors.lastname: Walling
authors.affiliation: Dr. Daniel is with Bracket Global, Washington, DC; Dr. Kalali is with Quintiles, San Diego, California; Mr. West is with Innovum Technologies, Las Vegas, Nevada (Mr. West was with ePharma Solutions, Plymouth Meeting, Pennsylvania, during the preparation of this executive summary); Dr. Walling is with Collaborative Neuroscience Network, Long Beach, California; Dr. Hilt is with Forum Pharmaceuticals, Waltham, Massachusetts; Dr. Engelhardt is with Cronos, Lambertville, New Jersey; Dr. Alphs is with Janssen Scientific Affairs, LLC, Titusville, New Jersey; Dr, Loebel is with Sunovion, Fort Lee, New Jersey; Dr. Vanover is with Intra-Cellular Therapies, New York, New York; Dr. Atkinson is with Finger Lakes Clinical Research, Rochester, New York; Dr. Opler is with ProPhase LLC, New York, New York; Dr. Sachs is with Bracket Global, Lexington, Massachusetts; Dr. Nations is with INC Research, Austin, Texas; and Dr. Brady is with inVentiv Health Clinical, Princeton, New Jersey.
authors.forename: Dana
authors.initials: D
authors.lastname: Hilt
authors.affiliation: Dr. Daniel is with Bracket Global, Washington, DC; Dr. Kalali is with Quintiles, San Diego, California; Mr. West is with Innovum Technologies, Las Vegas, Nevada (Mr. West was with ePharma Solutions, Plymouth Meeting, Pennsylvania, during the preparation of this executive summary); Dr. Walling is with Collaborative Neuroscience Network, Long Beach, California; Dr. Hilt is with Forum Pharmaceuticals, Waltham, Massachusetts; Dr. Engelhardt is with Cronos, Lambertville, New Jersey; Dr. Alphs is with Janssen Scientific Affairs, LLC, Titusville, New Jersey; Dr, Loebel is with Sunovion, Fort Lee, New Jersey; Dr. Vanover is with Intra-Cellular Therapies, New York, New York; Dr. Atkinson is with Finger Lakes Clinical Research, Rochester, New York; Dr. Opler is with ProPhase LLC, New York, New York; Dr. Sachs is with Bracket Global, Lexington, Massachusetts; Dr. Nations is with INC Research, Austin, Texas; and Dr. Brady is with inVentiv Health Clinical, Princeton, New Jersey.
authors.forename: Nina
authors.initials: N
authors.lastname: Engelhardt
authors.affiliation: Dr. Daniel is with Bracket Global, Washington, DC; Dr. Kalali is with Quintiles, San Diego, California; Mr. West is with Innovum Technologies, Las Vegas, Nevada (Mr. West was with ePharma Solutions, Plymouth Meeting, Pennsylvania, during the preparation of this executive summary); Dr. Walling is with Collaborative Neuroscience Network, Long Beach, California; Dr. Hilt is with Forum Pharmaceuticals, Waltham, Massachusetts; Dr. Engelhardt is with Cronos, Lambertville, New Jersey; Dr. Alphs is with Janssen Scientific Affairs, LLC, Titusville, New Jersey; Dr, Loebel is with Sunovion, Fort Lee, New Jersey; Dr. Vanover is with Intra-Cellular Therapies, New York, New York; Dr. Atkinson is with Finger Lakes Clinical Research, Rochester, New York; Dr. Opler is with ProPhase LLC, New York, New York; Dr. Sachs is with Bracket Global, Lexington, Massachusetts; Dr. Nations is with INC Research, Austin, Texas; and Dr. Brady is with inVentiv Health Clinical, Princeton, New Jersey.
authors.forename: Larry
authors.initials: L
authors.lastname: Alphs
authors.affiliation: Dr. Daniel is with Bracket Global, Washington, DC; Dr. Kalali is with Quintiles, San Diego, California; Mr. West is with Innovum Technologies, Las Vegas, Nevada (Mr. West was with ePharma Solutions, Plymouth Meeting, Pennsylvania, during the preparation of this executive summary); Dr. Walling is with Collaborative Neuroscience Network, Long Beach, California; Dr. Hilt is with Forum Pharmaceuticals, Waltham, Massachusetts; Dr. Engelhardt is with Cronos, Lambertville, New Jersey; Dr. Alphs is with Janssen Scientific Affairs, LLC, Titusville, New Jersey; Dr, Loebel is with Sunovion, Fort Lee, New Jersey; Dr. Vanover is with Intra-Cellular Therapies, New York, New York; Dr. Atkinson is with Finger Lakes Clinical Research, Rochester, New York; Dr. Opler is with ProPhase LLC, New York, New York; Dr. Sachs is with Bracket Global, Lexington, Massachusetts; Dr. Nations is with INC Research, Austin, Texas; and Dr. Brady is with inVentiv Health Clinical, Princeton, New Jersey.
authors.forename: Antony
authors.initials: A
authors.lastname: Loebel
authors.affiliation: Dr. Daniel is with Bracket Global, Washington, DC; Dr. Kalali is with Quintiles, San Diego, California; Mr. West is with Innovum Technologies, Las Vegas, Nevada (Mr. West was with ePharma Solutions, Plymouth Meeting, Pennsylvania, during the preparation of this executive summary); Dr. Walling is with Collaborative Neuroscience Network, Long Beach, California; Dr. Hilt is with Forum Pharmaceuticals, Waltham, Massachusetts; Dr. Engelhardt is with Cronos, Lambertville, New Jersey; Dr. Alphs is with Janssen Scientific Affairs, LLC, Titusville, New Jersey; Dr, Loebel is with Sunovion, Fort Lee, New Jersey; Dr. Vanover is with Intra-Cellular Therapies, New York, New York; Dr. Atkinson is with Finger Lakes Clinical Research, Rochester, New York; Dr. Opler is with ProPhase LLC, New York, New York; Dr. Sachs is with Bracket Global, Lexington, Massachusetts; Dr. Nations is with INC Research, Austin, Texas; and Dr. Brady is with inVentiv Health Clinical, Princeton, New Jersey.
authors.forename: Kim
authors.initials: K
authors.lastname: Vanover
authors.affiliation: Dr. Daniel is with Bracket Global, Washington, DC; Dr. Kalali is with Quintiles, San Diego, California; Mr. West is with Innovum Technologies, Las Vegas, Nevada (Mr. West was with ePharma Solutions, Plymouth Meeting, Pennsylvania, during the preparation of this executive summary); Dr. Walling is with Collaborative Neuroscience Network, Long Beach, California; Dr. Hilt is with Forum Pharmaceuticals, Waltham, Massachusetts; Dr. Engelhardt is with Cronos, Lambertville, New Jersey; Dr. Alphs is with Janssen Scientific Affairs, LLC, Titusville, New Jersey; Dr, Loebel is with Sunovion, Fort Lee, New Jersey; Dr. Vanover is with Intra-Cellular Therapies, New York, New York; Dr. Atkinson is with Finger Lakes Clinical Research, Rochester, New York; Dr. Opler is with ProPhase LLC, New York, New York; Dr. Sachs is with Bracket Global, Lexington, Massachusetts; Dr. Nations is with INC Research, Austin, Texas; and Dr. Brady is with inVentiv Health Clinical, Princeton, New Jersey.
authors.forename: Sarah
authors.initials: S
authors.lastname: Atkinson
authors.affiliation: Dr. Daniel is with Bracket Global, Washington, DC; Dr. Kalali is with Quintiles, San Diego, California; Mr. West is with Innovum Technologies, Las Vegas, Nevada (Mr. West was with ePharma Solutions, Plymouth Meeting, Pennsylvania, during the preparation of this executive summary); Dr. Walling is with Collaborative Neuroscience Network, Long Beach, California; Dr. Hilt is with Forum Pharmaceuticals, Waltham, Massachusetts; Dr. Engelhardt is with Cronos, Lambertville, New Jersey; Dr. Alphs is with Janssen Scientific Affairs, LLC, Titusville, New Jersey; Dr, Loebel is with Sunovion, Fort Lee, New Jersey; Dr. Vanover is with Intra-Cellular Therapies, New York, New York; Dr. Atkinson is with Finger Lakes Clinical Research, Rochester, New York; Dr. Opler is with ProPhase LLC, New York, New York; Dr. Sachs is with Bracket Global, Lexington, Massachusetts; Dr. Nations is with INC Research, Austin, Texas; and Dr. Brady is with inVentiv Health Clinical, Princeton, New Jersey.
authors.forename: Mark
authors.initials: M
authors.lastname: Opler
authors.affiliation: Dr. Daniel is with Bracket Global, Washington, DC; Dr. Kalali is with Quintiles, San Diego, California; Mr. West is with Innovum Technologies, Las Vegas, Nevada (Mr. West was with ePharma Solutions, Plymouth Meeting, Pennsylvania, during the preparation of this executive summary); Dr. Walling is with Collaborative Neuroscience Network, Long Beach, California; Dr. Hilt is with Forum Pharmaceuticals, Waltham, Massachusetts; Dr. Engelhardt is with Cronos, Lambertville, New Jersey; Dr. Alphs is with Janssen Scientific Affairs, LLC, Titusville, New Jersey; Dr, Loebel is with Sunovion, Fort Lee, New Jersey; Dr. Vanover is with Intra-Cellular Therapies, New York, New York; Dr. Atkinson is with Finger Lakes Clinical Research, Rochester, New York; Dr. Opler is with ProPhase LLC, New York, New York; Dr. Sachs is with Bracket Global, Lexington, Massachusetts; Dr. Nations is with INC Research, Austin, Texas; and Dr. Brady is with inVentiv Health Clinical, Princeton, New Jersey.
authors.forename: Gary
authors.initials: G
authors.lastname: Sachs
authors.affiliation: Dr. Daniel is with Bracket Global, Washington, DC; Dr. Kalali is with Quintiles, San Diego, California; Mr. West is with Innovum Technologies, Las Vegas, Nevada (Mr. West was with ePharma Solutions, Plymouth Meeting, Pennsylvania, during the preparation of this executive summary); Dr. Walling is with Collaborative Neuroscience Network, Long Beach, California; Dr. Hilt is with Forum Pharmaceuticals, Waltham, Massachusetts; Dr. Engelhardt is with Cronos, Lambertville, New Jersey; Dr. Alphs is with Janssen Scientific Affairs, LLC, Titusville, New Jersey; Dr, Loebel is with Sunovion, Fort Lee, New Jersey; Dr. Vanover is with Intra-Cellular Therapies, New York, New York; Dr. Atkinson is with Finger Lakes Clinical Research, Rochester, New York; Dr. Opler is with ProPhase LLC, New York, New York; Dr. Sachs is with Bracket Global, Lexington, Massachusetts; Dr. Nations is with INC Research, Austin, Texas; and Dr. Brady is with inVentiv Health Clinical, Princeton, New Jersey.
authors.forename: Kari
authors.initials: K
authors.lastname: Nations
authors.affiliation: Dr. Daniel is with Bracket Global, Washington, DC; Dr. Kalali is with Quintiles, San Diego, California; Mr. West is with Innovum Technologies, Las Vegas, Nevada (Mr. West was with ePharma Solutions, Plymouth Meeting, Pennsylvania, during the preparation of this executive summary); Dr. Walling is with Collaborative Neuroscience Network, Long Beach, California; Dr. Hilt is with Forum Pharmaceuticals, Waltham, Massachusetts; Dr. Engelhardt is with Cronos, Lambertville, New Jersey; Dr. Alphs is with Janssen Scientific Affairs, LLC, Titusville, New Jersey; Dr, Loebel is with Sunovion, Fort Lee, New Jersey; Dr. Vanover is with Intra-Cellular Therapies, New York, New York; Dr. Atkinson is with Finger Lakes Clinical Research, Rochester, New York; Dr. Opler is with ProPhase LLC, New York, New York; Dr. Sachs is with Bracket Global, Lexington, Massachusetts; Dr. Nations is with INC Research, Austin, Texas; and Dr. Brady is with inVentiv Health Clinical, Princeton, New Jersey.
authors.forename: Chris
authors.initials: C
authors.lastname: Brady
keywords: CNS; Data quality; clinical trial methodology; clinical trials; data monitoring; drug development; trial design