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Low number of phase-1 studies made it to publication

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A study was recently published in PLoS Medicine about poor dissemination of phase-1 study results in the medical literature, with only 17% of phase-1 studies performed in France in 1994 eventually making it to publication. This made quite a splash in the medical blogosphere.

In the study, the authors reviewed all approved phase-1 protocols in France during 1994 and then looked to see how many were completed and published, via a survey sent to the primary investigators. These studies were compared to similar outcomes for phase-2 to -4 trials during the same period of time.

The meat of the findings includes that, although phase-1 studies had better completion rates, only 17% of completed phase-1 studies were published in accessible medical literature (not in internal reports or textbooks) vs. 43% of the phase-2 to -4 studies conducted during the same period of time. Initially this seems very alarming, and just looking at the title I assumed these were oncology studies, but they were not. (What's that old saying? When all you have is a hammer, everything looks like a nail? When all you have is chemo, everything looks like an oncology phase-1 study ...)

Unfortunately, the authors do not provide a breakdown of which studies were healthy-volunteer phase-1 studies, and which were for cancer or HIV patients (patients, rather than volunteers). But my gut tells me if they did the breakdown in such a way, they would find that (1) the majority of oncology (and other patient-based) phase-1 studies are indeed published, and (2) oncology studies are more likely to be done at academic centers (rather than private or industry centers, which made up the majority of the sites in this study).

My anecdotal experience at my institution suggests that nearly all studies eventually make it to manuscript or abstract publication. Another weakness of this study is that it looked at studies done in 1994. I understand the rationale behind this — it gives the investigators more than enough time to complete the study and publish it. But I submit that awareness of publication bias is more widespread since then, and that if we conducted the same study now, we would find better rates of publication.