Where, Oh Where, Did The Clinical Trials Go? Many Are Unpublished

As the debate over releasing clinical trial data rages on, yet another study emerges indicating that nearly one-third of trials are not reported for five years after completion on the US government repository – known as ClinicalTrials.gov – as required with the passage of the FDA Amendments Act in 2007. And the findings are likely to add still more pressure on drugmakers to disclose clinical trial results. Specifically, of 585 registered trials, 171 – or 29 percent – remain unpublished and there were nearly 300,000 patients enrolled. And non-publication was more common among trials that received industry funding than those that did not – 32 percent compared with 18 percent. And of the 171 unpublished trials, 78 percent did not have results available on ClinicalTrials.gov. The study was published in BMJ. And the authors could not find results either in the published literature or in the results database at ClinicalTrials.gov for an estimated 250,000 participants. “The lack of availability of results from these trials contributes to publication bias and also constitutes a failure to honor the ethical contract that is the basis for exposing study participants to the risks inherent in trial participation,” the authors write (here is the study). This is not the first time an analysis has reached this conclusion. Last year, BMJ published a series of papers that examined lapses in clinical trial reporting and one found that that only 22 percent adhered to the mandate. ...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs