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Thursday, June 30 • 9:00am - 10:30am
#402: Protocol Development Is a Team Sport

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Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-16-612-L04-P; CME 1.50; IACET 1.50; RN 1.50

From stating study objectives, participant criteria, endpoints and methods for data collection to establishing safety, the protocol is a key document for all stakeholders to ensure a successful clinical trial. The protocol defines the study design and provides the foundation for data collection that is used to evaluate clinically and statistically meaningful results of a study. It defines to a great extent what will be known about a drug or medical intervention, and is thus highly relevant to diverse stakeholders. During this session, the requirements and considerations for developing a successful and executable clinical trial protocol will be presented from the perspectives of sponsors, research sites, and patient representatives. The unique viewpoints will serve as the basis for a moderated discussion that analyzes the current process for protocol development, while suggesting approaches to more fully incorporate the patient voice into protocol design and implementation.

Learning Objectives

Discuss the requirements and considerations for developing a clinical trial protocol from the combined perspectives of the statistician, the clinical operations director, the patients, the medical officers and the regulators; Describe a process for protocol writing that is holistic rather than atomistic and involves collaborative as opposed to separate contributions; Identify ways to more fully and impactfully incorporate patient input into protocol design and implementation.


Richard Murray, DrMed, MD, FACP


Michael Krams

Andy Lee, MA

Christine Pierre, RN

Steven Taylor, MBA

avatar for Richard Murray

Richard Murray

Vice President and Deputy Chief Medical Officer, Merck & Co., Inc.
Dr. Murray joined Merck & Co., Inc. in November 1994, and since August 2014 he has held the position of Vice President and Deputy Chief Medical Officer, managing a team of physician scientists supporting the scientific and medical needs for the Office of the CMO at Merck across all... Read More →

avatar for Michael Krams

Michael Krams

Vice President, Global Head Quantitative Sciences, Janssen Pharmaceuticals, Inc.
Mike is a neurologist with a background in functional imaging. One of his early contributions was the ASTIN stroke study, illustrating how adaptive designs allow learning in real time and enable teams to make the correct decision at the earliest time point in the most efficient manner... Read More →
avatar for Andy Lee

Andy Lee

Senior Vice President, Head of Global Clinical Trial Operations, Merck & Co., Inc., United States
Andy heads Global Clinical Operations at Merck and is responsible for all global/regional clinical trials. Andy has over 17 years industry experience with interests in Human Subject Protection, Multiregional Studies, Quality and Compliance and finding more efficient ways to run clinical... Read More →
avatar for Christine Pierre

Christine Pierre

President, Society for Clinical Research Sites
Christine is the President of the Society for Clinical Research Sites, a global trade organization representing over 9,000 sites in 47 countries committed to providing sites a community and voice for site sustainability. Christine is an internationally recognized expert on the global... Read More →
avatar for Steven Taylor

Steven Taylor

Chief Executive Officer, Sjögren's Syndrome Foundation
Since joining the Foundation as its CEO in 2003, Steve has focused on making Sjögren’s syndrome a household name by increasing awareness among the general public and healthcare professionals. In addition, under Steve’s leadership, the SSF has launched two major initiatives around... Read More →

Thursday June 30, 2016 9:00am - 10:30am EDT
103ABC Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 19: DIAmond, Forum