Category: Clinical

Surrogate Endpoints

Note: this is a short primer on surrogate endpoints. I plan to flesh out this post at a later date.

Surrogate endpoint is the most important, and the most dangerous, tool in the clinical trialist’s arsenal.

Surrogate endpoints are endpoints that are not clinically meaningful in itself but correlate with Continue reading “Surrogate Endpoints”

Why Clinical Trials Fail

Why do clinical trials fail?  That is to say, what do you need to know when you design a clinical trial so you can minimize the likelihood of failure?

Generally speaking, there are three root causes of clinical trial failures: molecule issues, logistic issues, and study design issues.  I will focus on the third, but will cover the other two briefly. Continue reading “Why Clinical Trials Fail”

CRO Management 101

I have a couple of friends who run small startup biotechs. They’re seriously considering doing their work in India, primarily because of lower costs, and asked me for some advice. I have accumulated quite a bit of expertise in doing trials in India, but since both of them are clinical trial novices, I put together some general CRO 101 advice for them. Here it is: Continue reading “CRO Management 101”

Reducing Sample Size

How to Reduce Sample Size for Clinical Trials

One of the questions you will often be asked if you’re a clinical trialist is: “Can’t we make the study smaller?” Reducing sample size without losing power can be accomplished by one of three ways. The first is to improve the signal-to-noise ratio. To do this, you can either reduce the noise, strengthen the signal, or reduce variability Continue reading “Reducing Sample Size”