What is a “serious or life threatening disease or condition”?
Consistent with current FDA and ClinicalTrials.gov guidance, the NIH interprets “serious and life-threatening disease or condition” to mean: (1) diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted and (2) diseases or conditions with potentially fatal outcomes, where the endpoint of clinical trial analysis is survival. The seriousness of a disease is a matter of judgment, but generally is based on such factors as survival, day-to-day functioning, and the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one. For example, acquired immunodeficiency syndrome (AIDS), all other stages of human immunodeficiency virus (HIV) infection, Alzheimer’s disease, angina pectoris, heart failure, cancer, and many other diseases are clearly serious in their full manifestations. Furthermore, many chronic illnesses that are generally well managed by available therapy can have serious outcomes
