Overview

• The double-blind design of the pembrolizumab trial prevented doctors from knowing whether Mr Williams received the active drug or a placebo when he fell critically ill, complicating urgent care decisions.
• Less than two weeks into treatment, the 76-year-old was admitted to Royal Preston Hospital, where he was initially treated for infection before being diagnosed with immunotherapy-related myocarditis and dying on May 6, 2024.
• Senior Coroner Chris Long’s July inquest highlighted failures in emergency unblinding and interdepartmental communication, leading to the trial’s cancellation by Merck Sharp & Dohme.
• Regulators from the MHRA and NICE now face pressure to tighten adverse-event reporting, enhance trial transparency and ensure robust safety oversight of high-cost immunotherapies.
• Lauren Williams has launched a campaign demanding transparent trial protocols and formalised emergency pathways to prevent similar tragedies for future patients.