Reporting Bias in Clinical Trials: What's the Current Status?

Citeline®, an Informa business unit, and the pharmaceutical industry's leading research authority on clinical trials, reported today that clinical trial transparency, also known as responsible data sharing, is in a much healthier state than shown in previous studies, when you refer to the right variety of sources.

Doro Shin, a Citeline analyst, presented the findings of her analysis today at the Pharma CI USA Conference in Parsippany, NJ, an event attended by competitive intelligence experts in the pharmaceutical industry.

"Prior analyses found that 23-57% of completed clinical trials do not report results. However, these analyses only included trials that met specific criteria and none included conference abstracts as a source for results disclosure. As such, I wanted to know what the current status is for results reporting among industry sponsors using broader inclusion criteria and across multiple sources for results," stated Ms. Shin.

For her analysis, Ms. Shin used Citeline's Trialtrove®, a competitive intelligence resource which draws data from over 30,000 sources. The analysis focused on nearly 7,500 Phase II-III industry sponsored trials with primary completion dates between 2008 and 2012, to determine how many of these trials provided results in peer reviewed sources (defined as a journal manuscript or conference abstract) or at clinicaltrials.gov.

Out of all the Phase II-III studies reviewed, a surprising 78% provided final or interim results across all sources. When looking just at the Phase III trials, the most expensive and high profile trials for sponsor companies, this number improves and 81% provide final or interim results.

Ms. Shin's presentation also focused on the disclosure rates among the top 20 pharma companies, which ranges from 55%-98% when all sources are consulted. Amgen appears to be the most dedicated to reporting, with 98% of its Phase III trials in the dataset showing results, followed closely by AstraZeneca and Celgene. Most sponsors report Phase III results in both peer reviewed sources and at clinicaltrials.gov, however some companies such as Astellas and Roche seem to favor posting their results in peer reviewed sources alone.

"Although sponsor companies are in fact assuming some degree of risk by reporting clinical trial results, either positive or negative," remarked Ms. Shin, "it is refreshing to see that they are becoming more and more committed to industry initiatives to improve transparency." From a competitive intelligence perspective, this improved access to trial results data leads to better informed strategic decisions and increased R&D productivity, provided the right sources are consulted. From an overall societal perspective, it helps provide better information to the patients participating in the trials and those who will eventually benefit from new or improved medicines.

To view the full analysis contained in the report - Reporting Bias in Clinical Trials: What's the current status? go to www.citeline.com/resource-center/whitepapers