PRESS-NEWS.org - Press Release Distribution
PRESS RELEASES DISTRIBUTION

Unpublished trial data 'violates an ethical obligation' to study participants, say researchers

Study finds almost 1 in 3 large clinical trials still not published 5 years after completion

2013-10-30
(Press-News.org) Contact information: Stephanie Burns
sburns@bmj.com
44-020-738-36920
BMJ-British Medical Journal
Unpublished trial data 'violates an ethical obligation' to study participants, say researchers Study finds almost 1 in 3 large clinical trials still not published 5 years after completion Almost one in three (29%) large clinical trials remain unpublished five years after completion.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 study published on bmj.com today.

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But when trial data remain unpublished, the societal benefit that may have motivated someone to enrol in a study remains unrealized.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So a team of US-based researchers set out to estimate the frequency of non-publication of trial results and, among unpublished studies, the frequency with which results are unavailable in the ClinicalTrials.gov database.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 The average time between study completion and the final literature search (November 2012) was 60 months for unpublished trials.

Registry entries for unpublished trials were then reviewed to determine whether results for these studies were available in the ClinicalTrials.gov results database.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

### END


ELSE PRESS RELEASES FROM THIS DATE:

Autism and language impairment genetically linked

2013-10-30
Autism and language impairment genetically linked Rutgers University scientists also find strong evidence of a genetic connection in areas of social skills and repetitive behaviors Lorenzo Miodus-Santini an 11-year-old sixth-grader from Princeton, who was classified ...

Warm winters let trees sleep longer

2013-10-30
Warm winters let trees sleep longer Climate change alters timing of spring growth in forests In the temperate zones, vegetation follows the change of the seasons. After a winter pause, plants put out new growth in spring. Research has now brought ...

New substance effectively combats multi-resistant bacteria

2013-10-30
New substance effectively combats multi-resistant bacteria MULTI-RESISTANCE: In Europe alone, more than 25,000 people die each year from infections caused by multi-resistant bacteria. Researchers from University of Copenhagen have now developed and characterized ...

Moral in the morning, but dishonest in the afternoon

2013-10-30
Moral in the morning, but dishonest in the afternoon Our ability to exhibit self-control to avoid cheating or lying is significantly reduced over the course of a day, making us more likely to be dishonest in the afternoon than in the ...

Institute explores intimate partner violence across generations

2013-10-30
Institute explores intimate partner violence across generations HUNTSVILLE, TX (10/30/13) -- Most parents who experienced intimate partner violence had children that grew to face violence in their own adult relationships, according to a study published by the Crime ...

How fat could help solve part of the diabetes problem

2013-10-29
How fat could help solve part of the diabetes problem The pancreas is a large organ that wraps around our gut, and produces the exact amount of insulin our bodies need when we eat – except when we start to develop diabetes, and insulin production ...

Did brain tumor stem cells originate from malignant neural stem cells?

2013-10-29
Did brain tumor stem cells originate from malignant neural stem cells? Although it is believed that glioma is derived from brain tumor stem cells, the source and molecular signal pathways of these cells are still unclear. The potential of neural stem cells to ...

Association between glioma susceptibility and XRCC1 Arg399Gln polymorphism

2013-10-29
Association between glioma susceptibility and XRCC1 Arg399Gln polymorphism DNA damage is an important mechanism of glioma. X-ray cross-complementing group 1 (XRCC1) is a DNA repair gene that participates in the base excision repair pathway. To date, many studies ...

A new DNA vaccine induces a Th2 immune response in Alzheimer's disease mice

2013-10-29
A new DNA vaccine induces a Th2 immune response in Alzheimer's disease mice Amyloid-beta (Aβ) active immunization in Alzheimer's disease can increase the rate of Aβ clearance, and delay cognitive dysfunction, but it is easy to induce meningoencephalitis, ...

New drug to help common bowel disease

2013-10-29
New drug to help common bowel disease An international team led by University of Adelaide researchers has identified the mechanism of pain relief of a new drug for treating Irritable Bowel Syndrome with Constipation (IBS-C), based on nonclinical ...

LAST 30 PRESS RELEASES:

Transnational electoral participation of undocumented Mexican immigrants in the US

A new method to build more energy-efficient memory devices for a sustainable data future

Freely levitating rotor spins out ultraprecise sensors for classical and quantum physics

‘Chinese lantern’ structure shifts into more than a dozen shapes for various applications

Towards light-controlled electronic components

Tiny architects, titanic climate impact: scientists call for October 10 to become International Coccolithophore Day

Stress sensitivity makes suicidal thoughts more extreme and persistent among the university population

Lessons from Ascension’s shark troubles could help boost conservation

Fire provides long-lasting benefits to bird populations in Sierra Nevada National Parks

Menstrual cycle affects women’s reaction time but not as much as being active

Housing associations more effective than government in supporting unemployed in deprived areas

Biochar helps composting go greener by cutting greenhouse gas emissions

Ulrich named president-elect of the AACI

Multitasking makes you more likely to fall for phishing emails

Researchers solve model that can improve sustainable design, groundwater management, nuclear waste storage, and more

Parched soils can spark hot drought a nation away

Uncovering new physics in metals manufacturing

Sped-up evolution may help bacteria take hold in gut microbiome, UCLA-led research team finds

The dose-dependent effects of dissolved biochar on C. elegans: Insights into the physiological and transcriptomic responses

New research reveals genetic link to most common pediatric bone cancer

Research conducted during 2024 eclipse reveals importance of light on bird behavior

Why does female fertility decline so fast? The key is the ovary

Total solar eclipse triggers dawn behavior in birds

Europe’s largest bats hunt and eat migrating birds on the wing, high in the sky

China’s emerging AI regulation could foster an open and safe future for AI

The secret to naked mole-rat’s longevity: Enhanced DNA repair

Acidic tumor environment promotes survival and growth of cancer cells

New biosensor tracks plants’ immune hormone in real time

New study finds gaps in REDD+ forest carbon offsets with most overstating climate impacts

Mystery solved: How Europe’s largest bat catches and eats passerines mid-air

[Press-News.org] Unpublished trial data 'violates an ethical obligation' to study participants, say researchers
Study finds almost 1 in 3 large clinical trials still not published 5 years after completion