Best practices for communicating clinical trial changes and delays

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It is always important to have contingency plans.

In the case of COVID-19, clinical trials – like many other planned activities – have been impacted and many companies have been forced to make some tough choices. When making the difficult, yet necessary, decision to delay a trial, communicating clearly and strategically across all affected audiences is critically important.

Communication is not only important when first making the decision to delay, but also ongoing as the status of the trial evolves. For more information on considerations for managing delays and possible issues, please see Assessing and managing issues around clinical trials: a multi-stakeholder approach.

When planning your communications, consider:

    1. Priority audiences who need to be updated
      • Your cadence of communication should begin with those closest to the trial plans (your employees and the trial investigators and study coordinators), and flow through to affected patients and regulatory partners, among other stakeholders.
    2. Method and timing of communication for key audiences
      • Employees – Colleagues should be informed as changes are decided and during key moments in time (e.g., when the trial resumes). Explain the status and reason behind the changes, acknowledge their work and potential disruptions, and express confidence in the path forward. Provide talking points for leaders, so they are prepared to respond to team questions. Ensure Comms and Investor Relations teams are working closely together and have the latest information from the lifecycle and brand teams.
      • Investigators/Study coordinators – Personalize communications per trial site/investigator/study coordinator (recognizing struggles, disruptions, etc.). When developing communications, consider the trial status and design, and necessary updates to reflect these details. Stay in touch during the delay period, as appropriate, to maintain connection.
      • Patients and caregivers – In some instances, the communication to study participants may be simple. For example, sharing that the clinical trial must halt for their safety. In other instances, it may be more complex. Where appropriate, offer template communications to help investigators stay in touch with participants. For more suggestions on engaging with patients, please see our Supporting study participants checklist.
      • External audiences (including media):
        • If the trial has been disclosed publicly, a proactive statement or press release for posting on your website, the newswire and/or social media is best practice. The level of dissemination will depend on the news climate, disclosures and media attention to date.
        • If the trial has not been disclosed, develop a reactive media statement for use in the event you receive an inquiry.
        • In both instances, prepare reactive talking points or responses to potential media questions to stay prepared and aligned.
    3. Tone
      • Be empathetic – Reflecting an empathetic tone across communications is critical, particularly given the current climate when a change or delay to a trial is one of many disruptions people are facing. The health and safety of the trial participants and site staff are of the utmost importance.
      • Avoid absolutes – Provide details, as appropriate, to help audiences understand clinical trial decisions, but avoid speaking in absolutes. No one can guarantee what will happen next with COVID-19, nor possibly with the trial itself. Transparency with the detail you are able to share will be respected.

Ongoing updates

As trial plans evolve, your communications plan should reflect all scenarios for future events and moments when it will be crucial to keep audiences apprised.

Have questions or need communications support on managing delays or changes to trials? We’re here to help. Please contact us to get started.

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We know there are numerous considerations when it comes to the impact of COVID-19 and what this means for your organization. We are here to help.