Communications Handbook for Clinical Trials:
Strategies, tips, and tools to manage controversy, convey your message, and disseminate results
Elizabeth T. Robinson;Deborah Baron;Lori L. Heise;Jill Moffett; Sarah V. Harlan
The handbook is co-published by the Microbicides Media and Communications Initiative, a multi-partner collaboration housed at the
Global Campaign for Microbicides at PATH in
Available online PDF [280p.] at: http://bit.ly/bpO27X
“….How clinical trials are perceived internationally and in communities where trials occur can directly affect support for research, with misinformation and fears of exploitation derailing trials just as easily as operational or scientific setbacks……..”
….Expectations for transparency, information sharing, and engagement are rising at the same time that the modes and outlets for communication are multiplying at an exponential rate. The media landscape is changing daily and international networks of advocates, scientists, and others are linked through the Internet as never before. In addition, an increasing number of people now see themselves as stakeholders in the research process. This new world brings both possibility and risk to those engaged in research.
“……This handbook is designed to serve the needs of anyone who conducts, plans, or implements clinical trials—especially trials that evaluate new drugs or interventions in a community setting.
Objectives
- Provide practical guidance to clinical trial staff and research partners on how to anticipate and respond to the special communications challenges posed by the conduct of clinical research in resource-limited settings.
- Share lessons learned from case studies of actual experiences running trials in Africa, Asia, Latin America, the
- Supply hard copy and electronic versions of diagnostic tools, sample templates, and model examples of communications plans and materials that sites can adapt for use in their communications planning and implementation…..”
The handbook addresses the challenges of communicating about clinical trials to stakeholders. Drawing on the collective insights of the many people who contributed to its creation, this handbook uses practical insights and case studies based on the communications activities of actual clinical trials.
A variety of tools and templates will help readers plan for their own studies, including:
- Sample communications plans for clinical trials
- Communications and crisis-planning templates and checklists
- Scenario-planning tools to facilitate planning for the release of trial results
- Ideas on delegating communications tasks to reduce demands on key site personnel
- Tips and techniques on how to communicate effectively in interviews, in meetings, and with the media….
Content
Chapter One: About This Handbook
Chapter Two: Preparing and Budgeting for Communications
Chapter Three: Developing a Strategic Communications Plan
Chapter Four: Communications During the Trial
Chapter Five: Preventing and Managing a Crisis
I. What is a crisis communications plan?
II. Why is a crisis communications plan needed?
III. Preventing crises
IV. Preparing for potential controversy
V. Developing a rapid response procedure
VI. Implementing your crisis communications plan
VII. Managing unexpected trial closures
Chapter Six: Preparing for and Disseminating Study Results
I. The minimum package of dissemination activities
II. The dissemination team and plan: compiling the core elements
III. Timing, timelines, and time zones
IV. Planning for various outcome scenarios
V. Managing embargoes and pre-release issues
VI. Orchestrating the public announcement
VII. Post-announcement dissemination activities
Chapter Seven: Developing and Using Key Messages
I. Why key messages are important
II. How to develop key messages and supporting messages
III. Creating tailored messages for any situation
IV. Refining and testing your messages
V. Delivering key messages
Chapter Eight: Communicating Science Clearly
I. Why research is necessary
II. Translating the language of clinical trials
III. Demystifying statistics
IV. Five ways to avoid misunderstandings
Chapter Nine: Working with the Media
I. Understanding the media
II. Developing a media strategy
III. Responding to media requests
IV. Getting your message across
V. Being interviewed by the media
VI. Helping journalists write good stories
VII. Nurturing relationships with the media
Appendices
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