Category: Clinical

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”