The description of risks in a clinical trial must be written in lay language and at an 8th grade level in the ICF. Ethics committees and IRBs require the risk language to be helpful and simple to understand.
A real life example is a study where we know that the trial drug can cause “changes in calcium levels” and we have to explain in the patient information (ICF) what that means in lay language.
Asking the right question to a capable AI can provide an excellent text for the information sheet.
I asked the AI this specific question:
“In layman’s terms what is changes in calcium levels. Short response please”
The Pharmacovigilance AI responded:
“Changes in calcium levels meaning the amount of calcium in your body is either too high or too low. Calcium is important for strong bones, muscle function, and nerve signaling. If calcium levels are too high, it can cause symptoms like fatigue, nausea, and kidney stones. If calcium levels are too low, it can lead to muscle cramps, weak bones, and mood changes.”
The known risk may be more complex and scientifically explained in the the investigator brochure but not with words that can be easily understood by the patient. Below is a series of risks and the translation into lay language
|Known risk to translate into lay language
|Question to the Pharmacovigilance AI
|AI response for the ICF
|Changes in blood tests including decreases in white blood cells (generally or specifically those called neutrophils or lymphocytes),
|In layman’s terms, including symptoms, what is changes in your blood tests including decreases in white blood cells (generally or specifically those called neutrophils or lymphocytes)
|Decrease in white blood cells, specifically neutrophils or lymphocytes, can indicate potential issues with your immune system.
White blood cells are an important part of your immune system and help fight off infections and diseases. Neutrophils and lymphocytes are two types of white blood cells.
If there is a decrease in white blood cells, it may make you more vulnerable to infections. Common symptoms can include frequent or persistent infections, such as respiratory infections, urinary tract infections, or skin infections. You may also experience fatigue, fever, and general weakness.
A decrease in neutrophils specifically (a condition called neutropenia) can put you at risk of bacterial infections. Symptoms may include fever, mouth sores, and skin infections.
A decrease in lymphocytes (a condition called lymphopenia) can weaken your immune response, making you more susceptible to viral infections. You may experience recurrent colds, flu-like symptoms, or infections that take longer to heal.”
|Low levels of red blood cells or platelets,
|In layman’s terms, including symptoms, what is low levels of red blood cells or platelets
|“Low levels of red blood cells, also known as anemia, can lead to symptoms such as fatigue, weakness, shortness of breath, pale skin, dizziness, and a rapid or irregular heartbeat. Red blood cells carry oxygen to the body’s tissues, so when their levels are low, it can affect oxygen delivery and cause these symptoms.
Low levels of platelets, called thrombocytopenia, can result in easy bruising, frequent or prolonged nosebleeds, excessive bleeding from cuts or injuries, or the formation of small red or purple spots on the skin. Platelets are responsible for blood clotting, so a decrease in their numbers can impair the body’s ability to form clots and control bleeding”
|Increase in activated partial thromboplastin time (blood clotting ability)
|In layman’s terms, including symptoms, what is Increase in activated partial thromboplastin time (blood clotting ability)
|Increase in activated partial thromboplastin time, which measures blood clotting ability, meaning that it takes longer for your blood to clot. This can result in symptoms such as excessive bleeding, easy bruising, heavy menstrual bleeding, frequent nosebleeds, and blood in urine or stools.
|Increased uric acid
|In layman’s terms, including symptoms, what is increased uric acid
|Increased uric acid meaning having higher levels of uric acid in the blood. This can lead to symptoms such as joint pain, especially in the big toe, swelling, redness, and tenderness.
|Increased alkaline phosphatase
|In layman’s terms, including symptoms, what is increased alkaline phosphatase
|Increased alkaline phosphatase meaning higher levels of an enzyme called alkaline phosphatase in the blood. Symptoms may include jaundice (yellowing of the skin and eyes), abdominal pain, bone pain or fractures, weakness or fatigue, and digestive problems.
|Decreased thyroid hormone production
|In layman’s terms, including symptoms, what is decreased thyroid hormone production
|Decreased thyroid hormone production, known as hypothyroidism, means that the thyroid gland isn’t making enough thyroid hormones. This can lead to symptoms like fatigue, weight gain, sensitivity to cold, dry skin and hair, muscle weakness, mood changes, memory problems, constipation, and menstrual irregularities.
Connect to the Pharmacovigilance AI here and try it out yourself