Industry Studies Have a Place Posted on November 13, 2007 Take a balanced stance on pharma-funded research, Terence A. Ketter (bio) advises.

There is a lot of discussion about collaboration with industry and conflict of interest and how the relationship between investigators and industry ought to be regulated. And this certainly is an evolving process and it’s constantly changing. And I think you need flexibility to keep up with the times and to anticipate that whatever is going on at one time, later on may be deemed inappropriate or out of touch with the current view of how things ought to be run. And certainly our relationships with industry have changed over time. It in a sense has kind of tightened things up a little bit, which can be both good and bad.

Industry support is crucial; it complements government support and foundation support. We have a kind of triad of government, foundation, industry. And industry, they are the people who come out with the new treatments. And all these new treatments that have been FDA approved for bipolar disorder, they weren’t as the result of NIH studies or foundation studies, they were industry studies.

So I think it’s important to have a balanced view of relationships with industry. What they are trying to do is important; for universities to be involved in registration trials I think is an important thing, and I would really worry if it was all clinical research organizations whose main thing is the bottom line of how many patients they recruit.

So part of being good academic citizens is to contribute to registration trials, and another part is to see that we have some balance with our relationships with industry. So we do investigator initiated studies. In general these are compounds that we’re enthusiastic about, that’s why we want to study them. But some of those studies are single-arm studies and they don’t have a placebo control group.

And when you’re doing something like that, you’re just trying to get an initial signal, see how well tolerated it is, see if a double blind placebo control trial is warranted. Those kind of studies are helpful in that regard. It’s important to not overinterpret those kind of studies, and I don’t think there is any pressure actually from industry in that regard. On the other hand, investigators are at risk for believing things before they prove them. And some of the small, single center, investigator initiated studies that are funded by industry are basically uncontrolled pilots that would present a convincing argument that somebody ought to pay for a controlled study.

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