Retaining independence in Clinical Trials

There is a very thoughtful and important commentary in Nature 446, 8th March 2007 p 137 on Keeping Faith with Trial Volunteers by Piccart and Goldhirsch and colleagues The article discusses the concept of clinical trails from the point of view of the volunteers. They give of themselves to very varying extent. From the giving of a sample of blood to full scale studies. It is only reasonable that they have the best of study design, data collection analysis and full publication of results. I suspect that the animals used in experiments should ask the same as they give everything of themselves and die.
The article talks of the large clinical trials which require huge financial resources, in excess of the moneys available to academic researchers. This means partnership with industrial sources of money. The article suggests that pharmaceutical companies may structure the trials to answer important questions for their own needs for their drugs. Which is very reasonable. Except that academics might and should want to use the trial to test hypotheses that would be important in developing new strategies. For example length of follow up.
They suggest that academic investigators negotiate with industry before committing themselves to trials in the following areas
data control. The important academic quest is to look at the data from every point of view. The funding company may not wish to do this and may withdraw financial support. That is the company is looking to control trial data.
the use of the companies statisticians to look at the data and not to give the raw material to the academics.
They suggest that the academics have first look at the data and then hand it on to the company which can then use the data for their own benefit.
All the time it is important to remember the trial subjects and their contribution. It is kind to contact the subjects after the trial is complete and to inform them of the outcome.

These big trials are less common in nutrition. They should happen and when they do, ,please define the rules of engagement with the funders.

Martin Eastwood
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