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Tuesday, July 9, 2013

Fixing clinical trial publication

When you try something and it fails, how eager are you to share your experience with the world? If you’re a research scientist, you may be just as inclined to crumple a failed experiment up and go back to the drawing board. There’s an understandable bias against publishing negative results. Unfortunately, it’s just as important to know what doesn’t work as what does work, especially when looking at medical tests. Because of this, Peter Doshi of Johns Hopkins and his colleagues are calling for researchers to provide all their clinical data, even from the trials that didn’t seem to go anywhere.

It isn’t just that data isn’t getting published at all. There are other ways that the public can be mislead about drug efficacies. Sometimes, trials are published but the results are badly misrepresented. In other cases, researchers are selective about how much of the raw data they include in the publication. This is not to say that scientists are deliberately being misleading. However, they may have decided that, for example, the ethnicity of the trial participants was not relevant enough to mention. This detail might prove to be important in a way that was not foreseen by the experimenters. 

To remedy these problems, Doshi and his colleagues are calling for institutions and investigators to publish, or correct and republish abandoned or misrepresented trials within the next year.

This is easier said than done. For one thing, there isn’t an official journal for unpublished trials. There may be a journal for every tiny speciality you can name, but ‘Experiments that Didn’t Work’ is not one of them. Second, it’s not clear who has responsibility for following Doshi’s guidelines. Can a third party demand access to data that the principal investigators have failed to publish? And who is responsible for interpreting the results to avoid biases and misrepresentations?

Hopefully, these problems can be ironed out. We’ll all have a better idea of the safety and limitations of drugs and medical procedures if the negative and positive results are freely available.

Doshi, P., Dickersin, K., Healy, D., Vedula, S., & Jefferson, T. (2013). Restoring invisible and abandoned trials: a call for people to publish the findings BMJ, 346 (jun13 2) DOI: 10.1136/bmj.f2865.