What to do if safety concerns lead to an unexpected trial closure


Click here to download a checklist that summarizes what should happen if the management decides to stop a trial after a recommendation by the DSMB to suspend the trial for safety reasons. In multicenter trials or those that have international sponsors, some of these actions may be coordinated and implemented centrally. It is important to establish a clear division of labor for those who will alert the various stakeholders listed below. Prompt and open communication with all stakeholders is essential in such situations.

  • Following the DSMB’s recommendation to close the trial, you should inform:
    • Trial leadership—all principal investigators for multisite trials
    • Trial sponsors and donors
    • Ministries of Health and government officials
    • Relevant ethics review committee(s)
    • Regulatory authorities and national food, drug, or poison control boards
    • National and international health organizations, such as the World Health Organization (WHO) and national AIDS councils
    • Manufacturer of the pharmaceutical product or device
  • Convene a meeting of key trial staff members to discuss an action plan. Engage the communications team to update and implement the crisis communications plan.
  • Conduct outreach to key stakeholders (internal and external).
    • Communicate personally with clinical trial partners and the funding agency
    • Coordinate with study staff in charge of informing participants
    • Organize a meeting with the trial’s CAB
    • Conduct teleconferences with the drug or device manufacturer
    • Contact the leadership of other related trials or trial networks
    • Contact leading local and global advocacy and civil society stakeholders
  • Seek agreement from major health organizations (such as WHO) to issue statements, if
  • Draft a press release. Check whether you need IRB approval to issue a statement to news media.
  • Distribute messages to key allies. Organize teleconferences with communication officers of all sponsoring groups, key advocacy networks, and allied scientists.
  • Monitor media coverage of closure.
  • Collect information from the community on an ongoing basis as the situation evolves.
  • Respond and follow up as needed.

October 3rd, 2013