What is the purpose of risk communication in clinical trials?

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Risk communication in clinical trials is about sharing information on identified risks and the actions taken to mitigate them with everyone who needs to know—investigators, trial staff, sponsors, oversight bodies, and, when appropriate, participants. This keeps all stakeholders informed, supports ongoing review of risks, and drives continual improvement of safety measures and trial processes. It’s a continuous, lifecycle activity that helps protect participants and preserve trial integrity by enabling timely decisions and coordinated responses to new or changing risks. It’s not primarily about recruiting participants, designing the protocol, or meeting submission deadlines. For example, when a safety signal is identified, risk communication involves updating the risk register, informing sites and committees, and adjusting training, SOPs, and consent materials as needed.