Notes from the Bottom of the Trial
Get the Book — $24Forty-two essays on what clinical trials look like from the chair the protocol forgot to imagine.
Forty Laws of the Coordinator, accreting across the book. Three Parts. One hundred sixty-seven pages. Composites, unsentimental.
This book is for the coordinator who is, at this moment, eight to thirty months into the job, who has stopped being able to sleep on Sunday nights, and who has started to suspect that the training was not adequate to the work.
It will not teach you the work. It will tell you that you are not the only one having the experience, and it will give you a vocabulary for what you are experiencing, which is half of what you need.
If you are a brand-new coordinator looking for a how-to manual, this is not it. There are manuals.
“This is not a manual. There are manuals. The certification boards publish them and the Code of Federal Regulations is, in its way, the longest and most expensive manual ever written. I have read them. So have you. None of them will help you on the Tuesday morning that this book is about.”
The PI is responsible for the trial. The coordinator runs the trial. These are not the same sentence, and the institution depends on the confusion. — § XIV · The Laws of the Coordinator (I), Law II
arranged in roughly the order I came to understand what they describe
Ish is a clinical research coordinator. He has worked at academic centers and at private sites, in oncology and cardiology and metabolic disease, and one rare-disease trial that ended badly for reasons that were no one's fault and everyone's.
He wrote this book because no one wrote it for him. The senior coordinator who trained him handed him a binder and said good luck. This book is what comes after good luck.
It is not a manual. There are manuals. None of them will help on the Tuesday morning the book is about.
The first protocol I was given was three hundred and twelve pages and I had been a clinical research coordinator for eleven days. The patient sitting across from me was fifty-eight years old. She had driven forty minutes for the screening visit. She had recently lost her husband. She told me this in the unprompted way that patients in clinic tell you things, as though the act of being in the chair has loosened something in them, and now they cannot remember which information is medical and which information is not, and so they offer all of it, and you receive all of it, and you write down the parts the regulations require you to write down.
She also mentioned, in the same easy register, that she took eighty-one milligrams of aspirin every morning. She had taken it that morning. She took it because her cardiologist had told her to take it, twelve years earlier, and she had not stopped.
I did not know if aspirin was prohibited.
I should have known. The information was in the protocol, in a table titled Prohibited and Restricted Concomitant Medications, which I would later find on page 147, and which I had glanced at during what is generously called my training.
If the patient is in the room and you are reading, you have already failed. The reading is what you do at night.
A note on what this is. Names, patients, colleagues, and institutions are composites. The events happened. The arrangement is a fiction. The lessons are not composites. The lessons are the only true things in the book.
Forty-two essays. One hundred sixty-seven pages. The book is what comes after good luck.
Forty-two essays on what clinical trials look like from the chair the protocol forgot to imagine.
Forty Laws of the Coordinator, accreting across the book. Three Parts. One hundred sixty-seven pages. Composites, unsentimental.