Mr. Green has stage 4 prostate cancer which has spread to the bones and liver and has become resistant to radiation and standard chemotherapy treatment. After 3 rounds of chemotherapy, his primary oncologist recommends that he participate in a clinical trial. He went to Dr. Red at the Saguaro Clinic after reading on the internet about a new Phase 1 clinical trial that the clinic is hosting, which is designed to target a specific receptor called AB-111 that may be present in malignant prostate, cervical, ovarian, and breast cells. After signing consent and completing the blood screens in the morning at the clinic, Mr. Green is told his liver enzymes are too high and the ranges specified in the protocol prohibit him from enrolling. Mr. Green is noticeably affected and distressed at this news, and Dr. Red recommends end-of-life care. Behind the scenes, this event is noted on official medical documents and trial study rosters as a "screen fail." This narrative, while fictional, is realistic because similar events occur in cancer clinical trial sites on a regular basis. I look at the inner "world" and mental journey of possible clinical trial candidates as they seek out information about clinical trials and gain understanding of their function \u2014 specifically in the context of Phase 1 cancer clinical trials. To whom is the language of the term "screen failure" useful? How does excluding individuals from clinical trials protect their health and does the integrity of the trial data supersede the person's curative goals? What is the message that cancer patients (potential research subjects) receive regarding clinical trials from sources outside their oncologists?
- Perception of Phase 1 Cancer Clinical Trials