Featured Research

from universities, journals, and other organizations

Transparency lacking in clinical trials, study finds

Date:
July 15, 2014
Source:
Boston University Medical Center
Summary:
A significant percentage of completed drug clinical trials, especially those funded by industry, are not disclosed to the public, years after being completed -- a trend that 'threatens the validity of the clinical research literature in the US,' according to a study.

A significant percentage of completed drug clinical trials, especially those funded by industry, are not disclosed to the public, years after being completed -- a trend that "threatens the validity of the clinical research literature in the U.S.," according to a study led by a Boston University School of Public Health (BUSPH) researcher.

Related Articles


The study, published in the journal PLOS ONE, found that close to 30 percent of 400 randomly selected clinical trials completed in 2008 had not resulted, four years later, in either publication in a journal or the posting of results to the ClinicalTrials.gov (CTG) web site.

Studies that were funded solely by industry, or that involved smaller sample sizes, were less likely to be published, the research shows.

The study's lead author, Dr. Christopher Gill, director of BUSPH's Pharmaceuticals Program and an associate professor of global health, said the review raises ethical, as well as scientific, problems.

"Individuals who volunteer for clinical trials often do so out of a sense of altruism," said Gill, a researcher with BU's Center for Global Health and Development. "I can imagine that many would be dismayed to learn that the results of a study that they participated in, that they took physical risks for, might never generate results known beyond the company that sponsored the trial.

"Science learns from mistakes, as well as successes," he said. "If we only learn about the scientific success stories, we are really only seeing part of the picture."

Gill and a former student, Hiroki Saito, found that 118 of the 400 clinical trials did not result in publication within four years of completion. The median length of time from completion to public disclosure was 602 days.

Among industry-funded studies, rates of posting to the CTG site were high for phase 3 or 4 studies, but extremely low for phase 2 studies.

"As an overall synthesis, these findings provide strong evidence of reporting bias," Gill and Saito wrote. They said the associations between publication or posting rates and funding sources "merit further consideration, and may reflect differing motivations" among researchers.

Among academics working under a "publish or perish" model, and who represent the majority of non-industry funded studies, the study phase "may be less critical than the need to publish research findings in journals," Gill and Saito said. By contrast, the pharmaceutical industry may publish more results for products that have advanced to phase 3 or beyond and are perceived to be commercially viable.

Gill and Saito suggested that regulatory requirements could be driving the differences in rates of posting results to the CTG. Among industry-funded, phase 3 or 4 studies, the majority of researchers posted their results at about one year from completion -- coinciding closely with a one-year deadline established in 2007 by the Food and Drug Administration Amendments Act (FDAAA).

Regardless of the reasons, Gill and Saito said, transparency in clinical trials is "an essential public health good. The public must be informed if the premise of a clinical trial was confirmed or invalidated, and expects that, once a study involving human subjects is completed, its results will be published in the medical literature or posted to some other open-access platform."

They said that in order to maintain the public's faith in clinical research, and to protect the fidelity of the scientific literature, "it is essential that the research community unite around the common goal of maximizing transparency. "

In 2012, Gill reported that among US-based, industry-funded phase 2 or higher clinical studies, less than 25 percent had posted their results to CTG within a year of completion. Another study found that, among National Institutes of Health-funded trials, 32 percent remained unpublished after the median follow-up of 51 months from completion.


Story Source:

The above story is based on materials provided by Boston University Medical Center. Note: Materials may be edited for content and length.


Journal Reference:

  1. Hiroki Saito, Christopher J. Gill. How Frequently Do the Results from Completed US Clinical Trials Enter the Public Domain? - A Statistical Analysis of the ClinicalTrials.gov Database. PLoS ONE, 2014; 9 (7): e101826 DOI: 10.1371/journal.pone.0101826

Cite This Page:

Boston University Medical Center. "Transparency lacking in clinical trials, study finds." ScienceDaily. ScienceDaily, 15 July 2014. <www.sciencedaily.com/releases/2014/07/140715214305.htm>.
Boston University Medical Center. (2014, July 15). Transparency lacking in clinical trials, study finds. ScienceDaily. Retrieved November 28, 2014 from www.sciencedaily.com/releases/2014/07/140715214305.htm
Boston University Medical Center. "Transparency lacking in clinical trials, study finds." ScienceDaily. www.sciencedaily.com/releases/2014/07/140715214305.htm (accessed November 28, 2014).

Share This


More From ScienceDaily



More Health & Medicine News

Friday, November 28, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Ebola Leaves Orphans Alone in Sierra Leone

Ebola Leaves Orphans Alone in Sierra Leone

AFP (Nov. 27, 2014) — The Ebola epidemic sweeping Sierra Leone is having a profound effect on the country's children, many of whom have been left without any family members to support them. Duration: 01:02 Video provided by AFP
Powered by NewsLook.com
Experimental Ebola Vaccine Shows Promise In Human Trial

Experimental Ebola Vaccine Shows Promise In Human Trial

Newsy (Nov. 27, 2014) — A recent test of a prototype Ebola vaccine generated an immune response to the disease in subjects. Video provided by Newsy
Powered by NewsLook.com
Pet Dogs to Be Used in Anti-Ageing Trial

Pet Dogs to Be Used in Anti-Ageing Trial

Reuters - Innovations Video Online (Nov. 26, 2014) — Researchers in the United States are preparing to discover whether a drug commonly used in human organ transplants can extend the lifespan and health quality of pet dogs. Video provided by Reuters
Powered by NewsLook.com
Today's Prostheses Are More Capable Than Ever

Today's Prostheses Are More Capable Than Ever

Newsy (Nov. 26, 2014) — Advances in prosthetics are making replacement body parts stronger and more lifelike than they’ve ever been. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
 
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:  

Breaking News:

Strange & Offbeat Stories

 

Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:  

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile iPhone Android Web
Follow Facebook Twitter Google+
Subscribe RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins