Preventing and Managing a
Crisis
Overview
This session will cover how to:
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Develop a crisis communications plan
Prevent crises
Prepare for crises
Implement your plan
Manage unexpected trial closures
Crisis Communication
• Managing the strategy, messages, timing and distribution
channels necessary to communicate effectively with
stakeholders in a highly charged atmosphere.
Potential Crises
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Safety concerns
Allegations of exploitation
Legal disputes
Political issues or personal vendettas
Disgruntled staff or participants
Problems attributed (rightly or wrongly) to the study, trial
network or sponsors
“Wise
“Wisecrisis
crisismanagement
managementbegins
beginsbefore
beforeaacrisis
crisisoccurs”
occurs”
– Robert L. Heath
Predictability of a Crisis
Crises, while unpredictable, often
have consistent qualities:
• Media interest intensifies.
• The need for complete, easily
understood information
increases
• Other people/organizations
will try to promote their own
agendas.
• Organizational credibility can
come into question.
Crisis Communications Plan
A crisis communications plan:
• Outlines steps that staff and partners
should follow at all levels when a
situation or event threatens to
negatively affect a trial
• Defines policies and procedures for
assessing and responding to situations
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Identifies the involvement of others to rapidly defuse
a crisis
Preventing Crises
• Ask yourself: what matters to people? What causes
concern?
• Identify, communicate with, listen to, understand and
accommodate all stakeholders.
• Establish a reliable outward flow of information and an
equally reliable intake of external opinion.
“The key to effective issues management is to build relationships
and trust ahead of time.”
– Lori Heise, Former Director, Global Campaign for
Microbicides
Preparing for Potential Controversy
Define your crisis communications team:
• All tasks should be clearly defined and assigned.
• Ensure that final approval authority is understood.
• Others not assigned should relay information and refer
inquiries to spokespersons.
Crisis Communications Team Planning
• Brainstorm potential crisis scenarios and rehearse these
situations.
• Formalize a rapid-response procedure.
• Develop and update a detailed contact sheet.
– Include mobile phones. Crises are not limited to working
hours.
• Identify key groups that should be kept informed during a
crisis.
Crisis Communications Team Planning
• Train project staff to identify warning signs.
• Identify and train spokespersons, external experts and key
staff.
– Limit the number of spokespeople who communicate with
the media, but do not cut off the flow of information to
the media.
• Provide updates with new information, even in times of
limited press coverage.
– Identify trusted media contacts. Maintain up-to-date
contact information for these journalists.
Does an Issue Need Managing?
Identify in-house decision makers and consider the following
criteria:
• Is the issue critical to your organization, trial, participants
or mission?
• Is it potentially high impact?
• Does the issue attract opposition from stakeholders or
opinion leaders that could exacerbate the crisis?
• Is the reputation of your organization likely to suffer
because of its association with this issue?
Crisis Response
• Be proactive.
• Ensure spokespersons are
available.
• Tailor communications to the
situation.
• Debrief once the situation
has been resolved.
Tips for Trial Spokespeople
• Be forthright.
• Know which questions to answer.
• Be available to the media.
• Provide updates when new
information becomes available.
Preparing for Unexpected Trial Closures
• Track planned Data Safety
Monitoring Board meetings to
stay informed of trial status.
• Update materials before
major milestones.
— Develop key messages for
all possible scenarios.
• Alert key stakeholders of
regular DSMB milestones.
Informing Stakeholders of Early Closures
• Prompt and open communication with all stakeholders is
essential.
• Publicly traded U.S. companies must ensure compliance with
SEC disclosure regulations, which further condenses the
timeframe to inform stakeholders.
Managing Unexpected Trial Closures
• First inform the trial leaders, sponsors, government officials, your
ethics committees, regulatory authorities, the manufacturer, and
national and international health organizations.
Other Steps to Take
• Draft a press release.
• Distribute key messages to allies.
• Monitor media coverage of the closure and collect
information from the community.
• Respond and follow up as needed.
Summary
• The best crisis management is crisis prevention.
• Proactive planning and rapid response are your best tools for
crisis management.
• Always remember the three Ts of crisis communications:
– Trust
– Transparency
– Truthfulness
For More Information
• publications@fhi360.org