SCOPE Europe 2023: Finding the Magic in the Middle: Combining Patient, Site, and RWD Ingredients to Ignite Study Activation


Breakout session challenges current creation methods.

In this session at SCOPE Europe 2023, Melissa Harris, director, senior global patient engagement, Fortrea, challenged assumptions about the right type and quantity of ingredients, and the right moments to be adding them to a protocol cauldron to transform patient engagement and study activation when it comes to engagement methodologies.

“Patients fill the gap in real-world data with their insights,” she began. “They talk to us their needs and what they want. They’re the most important people and we sometimes forget about that.”

Image Credit: Andy Studna

Image Credit: Andy Studna

Harris compared the process of activating clinical trials to baking a cake. “Why is a study excavation like making a cake? You have to get the layers right,” she explained. “You have to get all of your ingredients right because someone can ask you to come in three months early. You could, but it’s going to collapse, but if you have some icing on it you can hope for the best.”

The Fortrea executive then transitioned to the difficulties of clinical trials for boys with Duchenne muscular dystrophy. “Something terrifying that I’ve learned is that 60% of boys with Duchenne muscular dystrophy cannot go on clinical trials,” she stated. “The reason they come for a clinical trial is because every protocol includes a six-minute walk test. By the time a parent or child is ready for a walk test, they can’t do the six-minute walk test. So, we can’t actually look at the late phase of the disease, because the particles are exclusionary.”

Harris wrapped up her talk by comparing the clinical trial process to animals attempting to run away from a storm. “By the time the storm is over, everybody is tired and not talking to each other. You’re never going to have a clinical trial without some sort of storm,” she explained. “The best thing in this scenario is to run into the storm so we can network and be done before the worst of it hits, and we still have the energy that we need.”


Finding the Magic in the Middle: Combining Patient, Site and RWD Ingredients to Ignite Study Activation. October 17, 2023. SCOPE Europe 2023, Barcelona.

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