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International Clinical Trials

The Statistics of Success

 

You are at the seminal stage of developing your programme. A great concept has turned into a promising treatment, or amazingly useful device. Your colleagues are excited. The opportunity to successfully plan the lifecycle and the ultimate approval is in front of you. The first thing on the list: engage all of the right resources immediately. Are you leaving out an essential member of the team? The war stories abound, and I have a few to share. Beware: this is not for the meek. Walk away with one clear lesson: include a statistician early in the process and you can avoid major pitfalls. Not only could you be missing an opportunity, the consequences may be dire.

A CASE IN POINT

“Good fortune is what happens when opportunity meets with planning”, said Thomas Alva Edison, and indeed there have been many wonderful scientific breakthroughs that never happened. Here is one example. A San Diego firm working on developing a biological device for the use in severe wound care, concluded the previously announced auction of substantially all of its assets in connection with its bankruptcy. There were many reasons for the ultimate failure of this company, which had a very promising product that was going to change lives. Having been on the inside for one day in 2004, I became acutely aware that, had a few simple but critical steps been taken a few years prior, this story would have had a very different ending. What I found out from conversations with several key executives that day was that the trials had not been conducted using some of the basic rules of study design, and instruments used to collect data were not up to FDA standards. They went along thinking that their product was going to be easily accepted and approved. Who did they include in the planning? Medical, business and manufacturing specialists were in the mix. Their downfall began, as do many great failures, with one glaring omission. In this case, they left out one key player: the statistician. Had they brought this expert to the table from the start, their plans would have been scrutinised from a different angle, the correct methods for designing a solid trial, and the collection of information would have been carried out in a way that would have led to enforced database integrity. The trial was expensive, and not one that could afford to be repeated. The product had one chance to succeed, as is the case in many development plans, but it didn’t come to fruition. I came in after the damage was done and could see clearly that by that time the flaws were so significant that their worst fears were going to be realised. It did not take long for the company to come crashing down, with their product still on the shelf. When the next company decides to pick things up where they left off, hopefully they will have listened to Mr Edison’s words and learned from their mistakes.


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Jeffrey Davidson serves as Senior Director, Clinical Statistics, at Octagon Research Solutions, Inc, and oversees all statistical activities and staff, and provides strategic direction and leadership for all statistical functions. Prior to joining Octagon, he worked as Senior Vice President, Statistical Consulting, at a CRO where he developed and led the business unit responsible for providing statistical consultancy to clients in the life sciences industry. Jeffrey holds a BA in Psychology and a BS in Rehabilitation Education from Penn State, an MEd in Special Education from the College of New Jersey, and a PhD in METER from the University of Pennsylvania.
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