Communications Handbook for Clinical Trials Clinical Handbook for Communications Communications Handbook for Clinical Trials Communications Handbook for Clinical Trials: Strategies, tips, and tools to manage controversy, convey your Communications message, and disseminate results provides 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. Designed to be accessible and relevant to a wide audience, Communications Handbook for Clinical Trials will make your job easier, whether you are a researcher, a study coordinator, or a communications professional. Handbook The handbook contains diagnostic tools, sample templates, and materials that research sites can adapt for use. n Sample communication plans for clinical trials n Communications and crisis-planning templates and checklists n Scenario-planning tools to facilitate planning for the release of trial results for Clinical Trials n Ideas on delegating communications tasks to reduce demands on key site personnel n Tips and techniques on how to communicate effectively in interviews, in meetings, and with the media Communications Handbook for Clinical Trials contains more than 40 contributed pieces by researchers and communications experts, who share their ideas, lessons learned, and advice based on their experiences with trials in Africa, Asia, Europe, Latin America, and North America. Praise for Communications Handbook for Clinical Trials Strategies, tips, and tools “Too often clinical trial researchers think a clinical trial starts with participant enrollment and closes with the final clinic visit of the last participant, but in fact the life of a trial extends well before and after these points. to manage controversy, This manual addresses all of the things they don’t teach one at university—how to communicate effectively with a range of stakeholders, how to work with the media, and how to build relationships to navigate some of the challenges and unexpected outcomes we encounter all too often in research.” convey your message, and —Prof. Linda-Gail Bekker, Desmond Tutu HIV Foundation, University of Cape Town, South Africa disseminate results “The authors have combined their wealth of communications experience into a lively how-to guide with illustrations from many different fields ... Essential reading for all involved designing or implementing clinical trials, including those who think they know it all.” —Dr. Timothy M. Farley, Department of Reproductive Health and Research, World Health Organization, Geneva By “In an era where research into tangible health-related interventions is a global effort, this handbook represents a Elizabeth T. Robinson thoughtful, well-organized approach to developing communication strategies that address today’s challenges.” Deborah Baron —Dr. Patrick Ndase, Microbicide Trials Network and International Clinical Research Center, University of Lori L. Heise Washington, Kampala, Uganda Jill Moffett Preface written by ARCHBISHOP EMERITUS DESMOND M. TUTU, who is a tireless champion in the fight against Sarah V. Harlan AIDS and tuberculosis, and serves as patron of the Desmond Tutu HIV Foundation and the Desmond Tutu HIV Centre at the University of Cape Town’s Institute of Infectious Disease and Molecular Medicine. Preface by Archbishop Desmond M. Tutu Communications Handbook for Clinical Trials Strategies, tips, and tools to manage controversy, convey your message, and disseminate results By Elizabeth T. Robinson Deborah Baron Lori L. Heise Jill Moffett Sarah V. Harlan Preface by Archbishop Desmond M. Tutu Communications Handbook for Clinical Trials: Strategies, Tips, and Tools to Manage Controversy, Convey Your Message, and Disseminate Results Authors: Elizabeth T. Robinson, Deborah Baron, Lori L. Heise, Jill Moffett, Sarah V. Harlan © Family Health International ISBN: 1-933702-57-5 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 Washington, DC, and by Family Health International in Research Triangle Park, NC, USA. Global Campaign for Microbicides PATH 1800 K Street NW, Suite 800 Washington, DC 20006 USA Tel: +1.202.822.0033 Web: www.mmci-communications.org www.global-campaign.org Family Health International P.O. Box 13950 Research Triangle Park, NC 27709 USA Tel: +1.919.544.7040 E-mail: [email protected] Web: www.fhi.org This work was made possible by the generous support of the American people through the U.S. Agency for International Development (USAID) through dual grants to the Microbicides Media and Communications Initiative (MMCI), a project of the Global Campaign for Microbicides at PATH, and to Family Health International (FHI). The contents are the responsibility of FHI and do not neces- sarily reflect the views of USAID or the United States Government. Financial assistance was provided to FHI by USAID under the terms of Cooperative Agree- ment GPO-A-00-05-00022-00, the Contraceptive and Reproductive Health Tech- nologies Research and Utilization (CRTU) Program, and Cooperative Agreement GHO-A-00-09-00016-00, the Preventive Technologies Agreement (PTA) Pro- gram, and to PATH by USAID under the terms of Cooperative Agreement GPH- A-00-01-00005-00, the HealthTech IV Program. To request additional copies of the handbook, e-mail: [email protected]. Contents Preface vii Acknowledgments x Chapter One: About This Handbook 1 I. The purpose of this handbook 2 II. Challenges posed by clinical trials 4 III. Origins of the handbook 5 IV. How this handbook is organized 5 Chapter Two: Preparing and Budgeting for Communications 9 I. Doing your homework—a “desk review” 9 II. Conducting an environmental scan 10 III. Developing a communications budget 17 IV. Assembling a communications team 21 V. Training staff and spokespersons 22 Chapter Three: Developing a Strategic Communications Plan 27 I. Background and environmental analysis 27 II. Goals and objectives 29 III. The communications team 29 IV. Identification of key stakeholders 31 V. Strategy for ongoing communication with stakeholders 36 VI. Strategy for managing controversy—crisis communications 38 VII. Dissemination plan for trial results 39 VIII. Materials to support the trial 39 IX. Monitoring and evaluation 42 Chapter Four: Communications During the Trial 45 I. Announcing the start of your trial 45 II. Maintaining good communications 50 III. Tracking and responding to emerging issues 62 IV. Preparing for interim analyses 65 V. Disseminating results 67 Chapter Five: Preventing and Managing a Crisis 69 I. What is a crisis communications plan? 70 II. Why is a crisis communications plan needed? 70 III. Preventing crises 72 IV. Preparing for potential controversy 75 V. Developing a rapid response procedure 78 iii VI. Implementing your crisis communications plan 80 VII. Managing unexpected trial closures 81 Chapter Six: Preparing for and Disseminating Study Results 87 I. The minimum package of dissemination activities 88 II. The dissemination team and plan: compiling the core elements 88 III. Timing, timelines, and time zones 94 IV. Planning for various outcome scenarios 100 V. Managing embargoes and pre-release issues 104 VI. Orchestrating the public announcement 107 VII. Post-announcement dissemination activities 112 Chapter Seven: Developing and Using Key Messages 115 I. Why key messages are important 116 II. How to develop key messages and supporting messages 117 III. Creating tailored messages for any situation 123 IV. Refining and testing your messages 125 V. Delivering key messages 126 Chapter Eight: Communicating Science Clearly 131 I. Why research is necessary 131 II. Translating the language of clinical trials 137 III. Demystifying statistics 143 IV. Five ways to avoid misunderstandings 146 Chapter Nine: Working with the Media 149 I. Understanding the media 149 II. Developing a media strategy 156 III. Responding to media requests 166 IV. Getting your message across 170 V. Being interviewed by the media 172 VI. Helping journalists write good stories 175 VII. Nurturing relationships with the media 177 Appendices Appendix 2.1 A Risk Assessment Tool 180 Appendix 2.2 Microbicide Trials Network: Communications Planning Survey 182 Appendix 2.3 “Thirty Tough Questions” for Trial Staff 190 Appendix 3.1 Sample Strategic Communications Plan 192 Appendix 3.2 “Getting to Know Your Stakeholders” Template 195 Appendix 3.3 Contact List Template 196 Appendix 3.4 Samples of Newsletters for Clinical Trials 197 Appendix 3.5 Sample of Study “Backgrounder” 200 Appendix 3.6 Sample External Questions and Answers (Q&A) 202 Appendix 4.1 Template for a Monthly Summary Report on Communications 205 Appendix 5.1 How Unexpected Closures Can Affect Other Trial Sites: The Cellulose Sulfate Trial Closure in South Africa 207 iv Communications Handbook for Clinical Trials Appendix 5.2 Illustrative Crisis Communications Plan 208 Appendix 6.1 Sample of a Results Dissemination Plan by a South African Site 211 Appendix 6.2 Sample of a Results Dissemination Plan by a Peruvian Site 214 Appendix 6.3 Case Study: Timelines and Tasks for Disseminating the Results of HPTN 035 217 Appendix 6.4 Sample Questions to Include in an Internal Q&A for Trial Results, Based on Three Outcome Scenarios 220 Appendix 6.5 Sample Letter to Ethics Committee Requesting Review of Materials Needed for Dissemination 222 Appendix 6.6 Sample Letter Inviting Community Stakeholders to Learn