Unpublished trial results: the 'blind spot' in the clinical research world

01-Mar-2016 - Last updated on 01-Mar-2016 at 16:09 GMT

There are several underlying issues in the industry (Image: iStock)

There are several reasons why clinical trial results are kept secret – some of more concern than others.

According to a recent study by the Yale School of Medicine, less than 40% of clinical trials results were shared within two years of completion.

While the study focused on leading academic medical centers, the issue has been pervasive in the clinical research industry as a whole and has seen increased scrutiny as of late. (The team previously studied clinical trials sponsored by NIH and pharmaceutical companies).

As part their most recent study, the researchers reviewed more than 4,300 clinical trials and examined how many were published or had results reported on ClinicalTrials.gov within 24 months of the studies' completion.

Specifically, the team saw a three-fold variation in performance, with some institutions disseminating 16% of their completed clinical research, while others disseminated 55%.

"This is yet another blind spot in the clinical research enterprise, and we hope our findings will serve as a call to action," said Dr. Nihar Desai, assistant professor of medicine, Yale School of Medicine and a researcher at the Yale Center for Outcomes Research and Evaluation.

However, academic institutions may be uniquely positioned to lead the effort of transparency, according to Desai – as they are “dedicated to generating knowledge to improve health and health care.”

Checking the blind spot

There are a multitude of reasons why results have traditionally not been shared.

“The one that has created the most concern is that negative results or unfavorable results are not shared,” Desai told Outsourcing-Pharma.com.

This stems from an underlying issue that investigators and study sponsors “don’t feel as if they should be required to share the results of the trials they have led,” he added. Additionally, if a trial’s results are unfavorable, or if they may lead to competition, “investigators may be all the more likely to sequester findings.”

Unfortunately, while requirements do exist in order to promote clinical trial data sharing, there aren’t any enforcement mechanisms. “As such, investigators know that the requirements are requirements in name only,” added Desai. “There have not been any ramifications for failing to disseminate results – either from academic centers, journals, or funders.”

In order to create a sense of urgency to ensure timely dissemination, Desai proposed that funders incorporate previous performance on results dissemination into funding decisions. He also suggests that journals take data sharing into consideration during the adjudication of manuscripts, and that academic institution leaders’ include it into the promotions process.

With recent pressure on various fronts, some medical journals are proposing a data sharing mandate. As Outsourcing-pharma previously reported, the International Committee of Medical Journal Editors proposed new rules that would require authors to share clinical trial data as a prerequisite for manuscript publication last month. Various companies have also pledged commitments to data sharing.

“We firmly believe that the results of all trials, whether they are led by academic investigators, pharmaceutical companies, or CROs should have results disseminated,” said Desai.

“This stems from an ethical imperative (based on the promise made to patients who agreed to participate), and the fact that the integrity of the research enterprise, and clinical care depend on timely and transparent dissemination of results.”