Overview

Clinical trial information transparency is taking on new dimensions. Clinical trial sponsors and academia are facing a host of new registration requirements in the US, EU, and elsewhere. With evolving requirements comes new challenges, creating additional opportunities for knowledge-sharing and necessitating more interaction with peers. This conference will provide critical and timely information relating to global clinical trial disclosure and data transparency from those on the front lines.

This program has been developed in collaboration with the Clinical Trial Disclosure and Data Transparency Community.

Keynote Address Announced!

An-Wen Chan, MD DPhil (Oxon) FRCPC Phelan Senior Scientist, Women's College Research Institute; Professor, Dept of Medicine, University of Toronto; Adjunct Professor, ICES and Institute of Health Policy, Management and Evaluation; Mohs surgeon & dermatologist (cutaneous oncology), Women's College Hospital

September 13 | 10:00-10:45AM
Dr. An-Wen Chan is a clinical epidemiologist and dermatologic surgeon with an interest in research transparency and reporting biases. He helped launch the WHO International Clinical Trials Registry Platform. By producing and adopting evidence-based guidance for researchers and leveraging technology to design clinical trials, Dr. Chan hopes to promote a future where health research is accessible, transparent and high quality. Dr. Chan currently chairs the SPIRIT Initiative (Standard Protocol Items for Randomized Trials). Under Dr. Chan’s leadership, SPIRIT has received global endorsement by 33 organizations. Over 100 medical journals have introduced policies recommending that submitted trial protocols adhere to the SPIRIT guidelines.

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Who should attend?

Professionals involved in:

Compliance/Legal
Clinical trial disclosure
Transparency policies and compliance
Clinical operations
Medical writing, medical affairs, and medical communications
Regulatory
Publications
Biometrics
Data management
Disclosure
Data transparency/data sharing
Academia
Clinical/Medical Research
Patient Advocacy

Learning objectives

Discuss best practices to achieve good compliance
Assess the operational challenges and considerations in executing Innovative Trial Designs
Discuss the interplay between clinical data disclosure and transparency requirements

Program Committee

Suzanne Carlson, MA Consultant
ABSD Associates, LLC, United States
Kelly Coulbourne, MS Director, Clinical Trial Transparency and Disclosure
Pfizer Inc, United States
Patrick Fawcett Information Disclosure Administrator, Office of Research Protections
University of Pittsburgh, United States
Francine Lane, MBA Senior Director of Product Management
Citeline, United States
Robert Paarlberg, MS Principal
Paarlberg & Associates LLC, United States
Nancy Williams Associate Director, RSMO Document Publishing Solutions
Janssen Pharmaceuticals, United States
Merete Joergensen, MBA, MSc Clinical Disclosure and Transparency Expert
Merete-J Consulting, Denmark