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I have been asked for suggestions in the design of a surgical trial. The issue here lies in the design of the animal model. I am inexperienced in this area. If you have experience or can direct me to a good discussion of 1) sample size issues 2) issues in evaluation and 3) issues in species selection, please let me know.

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Paul Thompson
Director, Methodology and Data Analysis Center
Sanford Research/USD
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One one point - In Pharmaceutical drug development, the medical/toxicology/biology experts typically determine " the animal model". For a disease, say alzheimers' they would find an animal (often a mouse) that could exhibit the signs/ pathology etc. of the disease. In later stages of drug development, there may be testing in primates (chimps, etc.). 
It would be helpful to know about the surgery if your confidentiality agreement permits that.

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Chris Barker, Ph.D.
Consultant and
Adjunct Associate Professor of Biostatistics
www,barkerstats.com

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"In composition you have all the time you want to decide what to say in 15 seconds, in improvisation you have 15 seconds."
-Steve Lacy
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I think I can indicate, without divulging any key details, that the project involves a device for joining vessels (veins or arteries). The point of the animal side would be to demonstrate safety, efficacy, and lack of key AEs.

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Paul Thompson
Director, Methodology and Data Analysis Center
Sanford Research/USD
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Original Message:
Sent: 01-20-2014 12:17
From: Chris Barker
Subject: Design of animal pre-clinical trials

One one point - In Pharmaceutical drug development, the medical/toxicology/biology experts typically determine " the animal model". For a disease, say alzheimers' they would find an animal (often a mouse) that could exhibit the signs/ pathology etc. of the disease. In later stages of drug development, there may be testing in primates (chimps, etc.). 
It would be helpful to know about the surgery if your confidentiality agreement permits that.

-------------------------------------------
Chris Barker, Ph.D.
Consultant and
Adjunct Associate Professor of Biostatistics
www,barkerstats.com

---
"In composition you have all the time you want to decide what to say in 15 seconds, in improvisation you have 15 seconds."
-Steve Lacy
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As Chris points out, the animal to be used as a model is typically decided by animal toxicology/pre-clinical experts.  For surgeries, the animal is usually larger than a mouse...pigs are common...and sometimes dogs.  I can put you in touch with an excellent expert if you are interested in going to toxicologist/animal specialist.  We have worked together for more than 10 years so she is comfortable with interacting with statisticians and design elements.

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Susan Spruill
Statistical Consultant
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Original Message:
Sent: 01-21-2014 09:09
From: Paul Thompson
Subject: Design of animal pre-clinical trials

I think I can indicate, without divulging any key details, that the project involves a device for joining vessels (veins or arteries). The point of the animal side would be to demonstrate safety, efficacy, and lack of key AEs.

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Paul Thompson
Director, Methodology and Data Analysis Center
Sanford Research/USD
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Hello,

I am very pragmatic in terms of sample size.  The biggest constraint I find in working with animal models is budget.  Also take into account failure rate!  The smaller the animal model I find the more early "sacrifices", especially amongst resident surgeons. 

HTH
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Victor Johnson
Biostatistician
Jersey Shore University Medical Center
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Original Message:
Sent: 01-21-2014 09:02
From: Paul Thompson
Subject: Design of animal pre-clinical trials

I think I can indicate, without divulging any key details, that the project involves a device for joining vessels (veins or arteries). The point of the animal side would be to demonstrate safety, efficacy, and lack of key AEs.

-------------------------------------------
Paul Thompson
Director, Methodology and Data Analysis Center
Sanford Research/USD
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