Featured Research

from universities, journals, and other organizations

Unpublished trial data 'violates an ethical obligation' to study participants, say researchers

Date:
October 29, 2013
Source:
BMJ-British Medical Journal
Summary:
Almost one in three (29 percent) large clinical trials remain unpublished five years after completion. And of these, 78 percent have no results publicly available, finds a new study.

Almost one in three (29%) large clinical trials remain unpublished five years after completion. And of these, 78% have no results publicly available, finds a new study.

This means that an estimated 250,000 people have been exposed to the risks of trial participation without the societal benefits that accompany the dissemination of their results, say the authors.

They argue that this "violates an ethical obligation that investigators have towards study participants" and call for additional safeguards "to ensure timely public dissemination of trial data."

Randomized clinical trials are a critical means of advancing medical knowledge. They depend on the willingness of people to expose themselves to risks, but the ethical justification for these risks is that society will eventually benefit from the knowledge gained from the trial.

But when trial data remain unpublished, the societal benefit that may have motivated someone to enrol in a study remains unrealized.

US law requires that many trials involving human participants be registered -- and their results posted -- on the largest clinical trial website ClinicalTrials.gov. But evidence suggests that this legislation has been largely ignored.

So a team of US-based researchers set out to estimate the frequency of non-publication of trial results and, among unpublished studies, the frequency with which results are unavailable in the ClinicalTrials.gov database.

They searched scientific literature databases and identified 585 trials with at least 500 participants that were registered with ClinicalTrials.gov and completed prior to January 2009. The average time between study completion and the final literature search (November 2012) was 60 months for unpublished trials.

Registry entries for unpublished trials were then reviewed to determine whether results for these studies were available in the ClinicalTrials.gov results database.

Of 585 registered trials, 171 (29%) remained unpublished. Of these, 133 (78%) had no results available in ClinicalTrials.gov. Non-publication was more common among trials that received industry funding (32%) than those that did not (18%).

"Our results add to existing work by showing that non-publication is an important problem even among large randomized trials," say the authors. Furthermore, the sponsors and investigators of these unpublished trials infrequently utilize the ClinicalTrials.gov results database.

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," they add. "Additional safeguards are needed to ensure timely public dissemination of trial data," they conclude.


Story Source:

The above story is based on materials provided by BMJ-British Medical Journal. Note: Materials may be edited for content and length.


Journal Reference:

  1. C. W. Jones, L. Handler, K. E. Crowell, L. G. Keil, M. A. Weaver, T. F. Platts-Mills. Non-publication of large randomized clinical trials: cross sectional analysis. BMJ, 2013; 347 (oct28 9): f6104 DOI: 10.1136/bmj.f6104

Cite This Page:

BMJ-British Medical Journal. "Unpublished trial data 'violates an ethical obligation' to study participants, say researchers." ScienceDaily. ScienceDaily, 29 October 2013. <www.sciencedaily.com/releases/2013/10/131029220751.htm>.
BMJ-British Medical Journal. (2013, October 29). Unpublished trial data 'violates an ethical obligation' to study participants, say researchers. ScienceDaily. Retrieved September 16, 2014 from www.sciencedaily.com/releases/2013/10/131029220751.htm
BMJ-British Medical Journal. "Unpublished trial data 'violates an ethical obligation' to study participants, say researchers." ScienceDaily. www.sciencedaily.com/releases/2013/10/131029220751.htm (accessed September 16, 2014).

Share This



More Science & Society News

Tuesday, September 16, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

EU Ministers and Experts Meet to Discuss Ebola Reponse

EU Ministers and Experts Meet to Discuss Ebola Reponse

AFP (Sep. 15, 2014) The European Commission met on Monday to coordinate aid that the EU can offer to African countries affected by the Ebola outbreak. Duration: 00:58 Video provided by AFP
Powered by NewsLook.com
Despite The Risks, Antibiotics Still Overprescribed For Kids

Despite The Risks, Antibiotics Still Overprescribed For Kids

Newsy (Sep. 15, 2014) A new study finds children are prescribed antibiotics twice as often as is necessary. Video provided by Newsy
Powered by NewsLook.com
FDA Eyes Skin Shocks Used at Mass. School

FDA Eyes Skin Shocks Used at Mass. School

AP (Sep. 15, 2014) The FDA is considering whether to ban devices used by the Judge Rotenberg Educational Center in Canton, Massachusetts, the only place in the country known to use electrical skin shocks as aversive conditioning for aggressive patients. (Sept. 15) Video provided by AP
Powered by NewsLook.com
Frustration As Drone Industry Outpaces Regulation In U.S.

Frustration As Drone Industry Outpaces Regulation In U.S.

Newsy (Sep. 14, 2014) U.S. firms worry they’re falling behind in the marketplace as the FAA considers how to regulate commercial drones. 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:
from the past week

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