Clinical Trial--- here I come.

It is a long way from the gorilla habitat of the Virunga mountains of Central Africa to the Upper East Side of Manhattan, but old blogs never die.

I am here to begin participation in a Phase II Clinical trial of a new drug called: ARN-509. What does a Phase II trial entail? Here is a brief description lifted from a government website.

What is a clinical trial and what are its phases?

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:

In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

Over the course of the next several days, I will have blood drawn, have seven scans and go through the formal process of informed consent for this trial. The latter involves seeing my Sloan Kettering medical oncologist and also his research team. They will review the study protocol, discuss the currently-known risks, benefits and alternatives to this treatment plan and have me sign a lot of stuff. Entering a clinical trial seems to me somewhat akin to buying a gun (irony unintended). Once you sign the papers, you have to wait a week before they give you your medicine. This is imminently sensible as it allows the patient to step away from the "pressure" inherent in sitting before care-givers and also allows for the information presented during the informed consent process to sink-in and percolate. For me this means I have to fly back to NYC next week. Oh well.

Anyway, I will write more once I have been through the informed consent process. I have given the speech (or a similar one) a million times myself. I am curious about what it will be like for me. Also, more on ARN-509 to follow.