Workshop Summary and Agenda

Workshop summary

Numerous publications have called for better reporting of study design, execution, analysis and interpretation of preclinical studies. However, many studies still fall short with respect to rigor and reporting. The lack of adequate documentation complicates critical evaluation of the findings, impedes replication of results, and compromises the ability to build upon the body of research.

To identify the key causes of deficiencies in preclinical studies and provide recommendations for addressing them, NINDS convened a two-day workshop. The meeting brought together stakeholders capable of evaluating prior efforts to improve rigor and reporting to: (a) better understand the root causes of the limited success of past efforts, (b) recommend solutions to overcome the obstacles preventing better study design and comprehensive reporting, and (c) suggest standards for review and reporting that are sufficient to increase confidence in reported results and their reliability.

Workshop Agenda and links to presentations

Wednesday, June 20, 2012

Introduction
Story Landis, National Institute of Neurological Disorders and Stroke (NINDS)
Walter Koroshetz, NINDS

Prologue
Shai Silberberg, NINDS

Session 1: Published Guidance
This session focused on lessons learned from previous efforts to enhance the rigor, objectivity and reporting of research by different disease communities. The panel included*:

• Susan Amara, University of Pittsburgh School of Medicine
• Howard Fillit, Alzheimer’s Drug Discovery Foundation (PDF) (PPT)
• Sharon Hesterlee, Parent Project Muscular Dystrophy and The Association for Frontotemporal Degeneration (PDF) (PPT)
• David Howells, University of Melbourne (PDF) (PPT)
• John Huguenard, Stanford University
• Dimitri Krainc, Harvard Medical School and Massachusetts General Hospital
• Stanley Lazic, Bioinformatics and Exploratory Data Analysis, F. Hoffmann-La Roche, Basel, Switzerland (PDF) (PPT)
• Steve Perrin, ALS Therapy Development Institute (PDF) (PPT)
• Amelie Gubitz, NINDS Moderator

*Presentations by panel members are accessible via the hyperlinks adjacent to their names.

Session 2: Journal Perspective
This session focused on efforts by scientific journals to assure the quality of publications. The panel included*:

• Katja Brose, Neuron
• Karen Carniol, Cell
• Robert Golub, JAMA
• Robert Gross, Neurology (PDF) (PPT)
• Katrina Kelner, Science
• Veronique Kiermer, Nature
• Kalyani Narasimhan, Nature Neuroscience (PDF) (PPT)
• Shai Silberberg, NINDS Moderator (PDF) (PPT)

*Presentations by panel members are accessible via the hyperlinks adjacent to their names.

Session 3: Reviewer Perspective
This session focused on the adequacy of methodology/data reporting in manuscripts, and grant applications, and of review guidelines. The panel included*:

• Robi Blumenstein, CHDI Management
• Eileen Bradley, Center for Scientific Review, NIH
• Robert Darnell, Investigator, Rockefeller University
• Marc Fisher, University of Massachusetts Medical School
• Howard Gendelman, University of Nebraska Medical Center
• John Goudreau, Michigan State University
• Elizabeth Loder, Brigham and Women’s/Faulkner Hospitals
• Malcolm Macleod, University of Edinburgh (PDF) (PPT)
• Linda Noble, University of California San Francisco
• Ursula Utz, NINDS Moderator

*Presentations by panel members are accessible via the hyperlinks adjacent to their names.

Thursday, June 21, 2012

Experiences in Collaborating with Academia
Khusru Asadullah, Bayer Pharma AG (PDF) (PPT)

Session 4: Investigator Perspective
This session was designed as a panel discussion among investigators as the target audience of messaging on rigor and objectivity in conduct and reporting of research results. The panel included:

• Chris Austin, National Center for Advancing Translational Science, NIH
• Ronald Crystal, Weill Cornell Medical College
• Robert Ferrante, University of Pittsburgh
• Michael Levine, University of California Los Angeles
• John McCall, PharMac LLC (PDF) (PPT)
• Richard Moxley, University of Rochester (PDF) (PPT)
• Oswald Steward, University of California Irvine (PDF) (PPT)
• Ellis Unger, Office of New Drug Evaluation-I, Food and Drug Administration (PDF) (PPT)
• John Porter, NINDS Moderator

Session 5: Recommendations
This session formulated broadly-accepted suggestions for optimizing the predictive value of preclinical research.

Participant List (PDF)