Pharmaceutical Industry Committing To Trial Transparency

Citeline, a pharmaceutical industry research authority, issued a press release on the state of clinical trial transparency in the industry today. According to Citeline, a previous study found that 23 to 57 percent of trials were not reported, leaving much to be desired in terms of industry transparency. However, in its new report, Citeline included broader criteria and multiple sources, therefore offering a more accurate result. The study included 7,500 Phase II and III trials from 2008 to 2012. Ms. Shin found the results “surprising,” as the study revealed that 78 percent provided final or interim results to journals, conferences, or clinicaltrials.gov. For Phase III trials, 81 percent disclosed results.

Citeline’s report comes just as the U.K.’s National Institute for Health and Care Excellence (NICE) considers forcing industry to disclose trial results. Last week, one day before Citeline released its data, NICE, the U.K.’s medicines agency, issued a press release stating that it will ask European regulatory authorities for trial data if pharmaceutical companies refuse to provide the data. Professor David Haslam, NICE Chair, said that he sees no reason not to publish all the data and feels that it is a moral imperative to publish results for the public domain.

Haslam isn’t the only one who feels this way about transparency. He is joined by a large percentage of doctors in the U.K. that recently revealed their own desires for trial transparency. A survey conducted by the Faculty of Pharmaceutical Medicine (FPM) of the Royal Colleges of Physicians of the United Kingdom found that 89 percent of doctors and pharmaceutical experts believe that increased publication of trial results leads to better medicines and better healthcare. Another measure found 81 percent agreeing that it is a moral duty to report results. However, at least 10 percent said that trial transparency may hurt the industry. Respondents differed on how to manage greater transparency, with most (61 percent) saying that either current regulatory organizations or a newly established independent body should act as the gatekeeper.

Doro Shin, Citeline analyst, said, "Although sponsor companies are in fact assuming some degree of risk by reporting clinical trial results, either positive or negative, it is refreshing to see that they are becoming more and more committed to industry initiatives to improve transparency."