"I'll Get Less Than Standard Care"

First, all medical trials must include at least the current best standard of care to satisfy the ethical principle of “equipoise”. In fact, while on a trial, there is an additional health care team member involved such as the protocol nurse or clinical research coordinator, who serves as another provider of support, information and advocacy.  Also, while on trial, there are often additional tests required -- above the standard of care-- which may discover problems earlier than expected and lead to corrective or preventative action.   For example, most trials call for mandatory screening EKGs (which oncologists don’t routinely perform off protocol) that might discover treatable cardiac abnormalities before they cause complications.  Lastly, every new clinically significant symptom, complaint, or lab abnormality is documented, graded, and medically investigated as required by the FDA’s Good Clinical Practice (GCP, http://www.fda.gov/oc/gcp/default.htm).