RSSDrug Development

Special Challenges in Pediatric Drug Development: First of Three Sets of Expanded Proceedings from the ISCTM Autumn Conference on Pediatric Drug Development

Special Challenges in Pediatric Drug Development: First of Three Sets of Expanded Proceedings from the ISCTM Autumn Conference on Pediatric Drug Development

| March 1, 2023

by Philip D. Harvey, PhD; Joan Busner, PhD; Gahan Pandina, PhD; H. Gerry Taylor, PhD; Meg Grabb, PhD; and Joohi Jimenez-Shahed, MD  Dr. Harvey is with Department of Psychiatry, University of Miami Miller School of Medicine in Miami, Florida. Dr. Busner is with Signant Health in Blue Bell, Pennsylvania and Department of Psychiatry, Virginia Commonwealth […]

Continue Reading

Implications of Pediatric Initiatives on CNS Drug Development for All Ages—2020 and Beyond: Second of Three Sets of Expanded Proceedings from the 2020 ISCTM Autumn Conference on Pediatric Drug Development

Implications of Pediatric Initiatives on CNS Drug Development for All Ages—2020 and Beyond: Second of Three Sets of Expanded Proceedings from the 2020 ISCTM Autumn Conference on Pediatric Drug Development

| March 1, 2023

by Gahan Pandina, PhD; Joan Busner, PhD; Joseph P. Horrigan, MD; Christine McSherry, RN, BSN; Alison Bateman-House, MA, MPH, PhD; Luca Pani, MD; and Judith Kando, PharmD, BCPP Dr. Pandina is with Janssen Pharmaceuticals in Titusville, New Jersey. Dr. Busner is with Signant Health in Blue Bell, Pennsylvania and Department of Psychiatry, Virginia Commonwealth University School […]

Continue Reading

Patient Centricity: Design and Conduct of Clinical Trials in Orphan Diseases: Third of Three Sets of Expanded Proceedings from the 2020 ISCTM Autumn Conference on Pediatric Drug Development

Patient Centricity: Design and Conduct of Clinical Trials in Orphan Diseases: Third of Three Sets of Expanded Proceedings from the 2020 ISCTM Autumn Conference on Pediatric Drug Development

| March 1, 2023

by Joan Busner, PhD; Gahan Pandina, PhD; Simon Day, PhD; Atul Mahableshwarkar, MD; Lucas Kempf, MD; Maria Sheean, MD; and Judith Dunn, PhD  Dr. Busner is with Signant Health in Blue Bell, Pennsylvania and Department of Psychiatry, Virginia Commonwealth University School of Medicine in Richmond, Virginia. Dr. Pandina is with Janssen Pharmaceuticals in Titusville, New Jersey. Dr. […]

Continue Reading

Using Artificial Intelligence-based Methods to Address the Placebo Response in Clinical Trials

Using Artificial Intelligence-based Methods to Address the Placebo Response in Clinical Trials

| January 1, 2022

by Erica A. Smith, PhD; William P. Horan, PhD; Dominique Demolle, PhD; Peter Schueler, MD; Dong-Jing Fu, MD, PhD; Ariana E. Anderson, PhD; Joseph Geraci, MSc, PhD; Florence Butlen-Ducuing, MD, PhD; Jasmine Link, MS; Ni A. Khin, MD; Robert Morlock, PhD; and Larry D. Alphs, MD, PhD Drs. Smith and Demolle are with Cognivia in Mont St. […]

Continue Reading

Clinician- and Patient-reported Endpoints in CNS Orphan Drug Clinical Trials: ISCTM Position Paper on Best Practices for Endpoint Selection, Validation, Training, and Standardization

Clinician- and Patient-reported Endpoints in CNS Orphan Drug Clinical Trials: ISCTM Position Paper on Best Practices for Endpoint Selection, Validation, Training, and Standardization

| October 1, 2021

by Joan Busner, PhD; Gahan Pandina, PhD; Silvia Zaragoza domingo PhD; Anna-Karin Berger PhD; Maria T. Acosta, MD; Nahome Fisseha, PharmD; Joseph Horrigan, MD; Jelena Ivkovic, MD; William Jacobson, PhD; Dennis Revicki, PhD; and Victoria Villalta-Gil, PhD, MSc All authors are members of the ISCTM Working Group for Rare Disease/Orphan Drug Development; Drs. Busner and Pandina […]

Continue Reading

The Effect of Acutely Administered Propofol on Forced Swim Test Outcomes in Mice

The Effect of Acutely Administered Propofol on Forced Swim Test Outcomes in Mice

| September 1, 2019

by David G. Daniel, MD; Noah G. Daniel; Donald T. Daniel; Laura Copeland Flynn, MS; and Michael H. Allen, MD Dr. Daniel is with Bioniche Global Development, LLC in McLean, Virginia and the George Washington University in Washington DC. Mr. N. Daniel is with Dartmouth College in Hanover, New Hampshire. Mr. D. Daniel is with […]

Continue Reading

Correlation Between the Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale and Nonmotor Scales in Patients with Parkinson’s Disease

Correlation Between the Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale and Nonmotor Scales in Patients with Parkinson’s Disease

| September 1, 2019

by Erika D. Driver-Dunckley, MD; Nan Zhang, MS; Holly A. Shill, MD; Shyamal H. Mehta, MD, PhD; Christine M. Belden, PsyD; Edward Y. Zamrini, MD; Kathryn Davis; Thomas G. Beach, MD, PhD; and Charles H. Adler, MD, PhD Drs. Driver-Dunckley, Mehta, and Adler are with the Department of Neurology of the Parkinson’s Disease and Movement […]

Continue Reading

Is High Placebo Response Really a Problem in Depression Trials? A Critical Re-analysis of Depression Studies

Is High Placebo Response Really a Problem in Depression Trials? A Critical Re-analysis of Depression Studies

| July 1, 2019

by Mark E. Whitlock, PhD; Philip W. Woodward, MPhil; and Robert C. Alexander, MD Dr. Whitlock is BioStatistics Head of Internal Medicine, Early Clinical Development, for Pfizer in Cambridge, United Kingdom. Mr. Woodward is an independent statistics consultant in Newmarket, United Kingdom. Dr. Alexander is with Takeda Pharmaceuticals International Company in Cambridge, Massachusetts. Funding: No […]

Continue Reading