Nav: Home

Researchers urged to share landmark trial data on safety of starch solutions

March 02, 2016

A group of researchers are today being urged to share their data for a landmark trial that raised safety concerns about the use of starch solutions.

In a special report published today, The BMJ's Associate Editor Peter Doshi sets out the facts of the case and asks, is it right for academics to withhold data and prevent independent scrutiny of their results?

The CHEST trial raised safety concerns about the use of hydroxyethyl starch (HES) to replace lost blood volume in critically ill patients. It was published in the New England Journal of Medicine (NEJM) in 2012 and led European and American regulators to suspend use of HES across much of the world.

Fresenius Kabi - a leading manufacturer of HES products and a major sponsor of the CHEST trial - questions the results and wants to verify the data.

But the trial investigators have refused to share the raw study data because they are concerned that the company would bias the reanalysis.

They have also refused a request to release the data to Yale cardiologist Harlan Krumholz for reanalysis by independent parties under his Yale open data access (YODA) scheme.

Fresenius Kabi agreed to fund Yale's efforts but otherwise not influence the process.

Principal CHEST trial investigator, John Myburgh said "We have no issue with the concept of data sharing. The concerns we have come down to the people with ulterior motives which contradict or do not adhere to the scientific principles we adhere to. That's the danger."

"This case exemplifies the broader cultural shift in medicine," commented physician author and transparency advocate Ben Goldacre, whom Fresenius Kabi contacted for help. He added: "The researchers should hand these data over, and if they want to be taken seriously, the sponsors [Fresenius Kabi] should set out their protocol for analysing it before they receive the files."

Myburgh is confident about the conclusions that can be drawn from his trial. But another CHEST study investigator who was not a coauthor of the NEJM article told The BMJ on condition of anonymity that he was "uncomfortable with the way renal complications were interpreted [in the NEJM paper]."

Fresenius claims to have discovered problems in the CHEST investigators' handling of adverse event data. But when the company put its concerns to NEJM, the journal said there had been no breach of scientific protocol and that no change was needed to its published material.

Doshi points out that when regulators issued public warnings about HES products, they did so without any access to the CHEST trial's underlying data. He says this case "highlights the degree to which current scientific publishing practices and regulatory decisions are based on blind trust and strengthens the call for a shift to open data."

Independent investigators "should not shy away from a secondary analysis that raises legitimate questions about the original study," writes Professor Michael Murray in an accompanying editorial.

Although he shares concerns about bias when data are released to anyone who may have a hidden agenda, he says "we must remember that not all primary investigators are above reproach and not all drug companies are pariahs."

"My view is that data sharing is good, whoever makes the request. It's up to us to overcome any bumps in the road that we encounter in our search for answers," he concludes.
-end-


BMJ

Related Data Articles:

Discrimination, lack of diversity, & societal risks of data mining highlighted in big data
A special issue of Big Data presents a series of insightful articles that focus on Big Data and Social and Technical Trade-Offs.
Journal AAS publishes first data description paper: Data collection and sharing
AAS published its first data description paper on June 8, 2017.
73 percent of academics say access to research data helps them in their work; 34 percent do not publish their data
Combining results from bibliometric analyses, a global sample of researcher opinions and case-study interviews, a new report reveals that although the benefits of open research data are well known, in practice, confusion remains within the researcher community around when and how to share research data.
Designing new materials from 'small' data
A Northwestern and Los Alamos team developed a novel workflow combining machine learning and density functional theory calculations to create design guidelines for new materials that exhibit useful electronic properties, such as ferroelectricity and piezoelectricity.
Big data for the universe
Astronomers at Lomonosov Moscow State University in cooperation with their French colleagues and with the help of citizen scientists have released 'The Reference Catalog of galaxy SEDs,' which contains value-added information about 800,000 galaxies.
What to do with the data?
Rapid advances in computing constantly translate into new technologies in our everyday lives.
Why keep the raw data?
The increasingly popular subject of raw diffraction data deposition is examined in a Topical Review in IUCrJ.
Infrastructure data for everyone
How much electricity flows through the grid? When and where?
Finding patterns in corrupted data
A new 'robust' statistical method from MIT enables efficient model fitting with corrupted, high-dimensional data.
Big data for little creatures
A multi-disciplinary team of researchers at UC Riverside has received $3 million from the National Science Foundation Research Traineeship program to prepare the next generation of scientists and engineers who will learn how to exploit the power of big data to understand insects.

Related Data Reading:

Best Science Podcasts 2019

We have hand picked the best science podcasts for 2019. Sit back and enjoy new science podcasts updated daily from your favorite science news services and scientists.
Now Playing: TED Radio Hour

Changing The World
What does it take to change the world for the better? This hour, TED speakers explore ideas on activism—what motivates it, why it matters, and how each of us can make a difference. Guests include civil rights activist Ruby Sales, labor leader and civil rights activist Dolores Huerta, author Jeremy Heimans, "craftivist" Sarah Corbett, and designer and futurist Angela Oguntala.
Now Playing: Science for the People

#520 A Closer Look at Objectivism
This week we broach the topic of Objectivism. We'll be speaking with Keith Lockitch, senior fellow at the Ayn Rand Institute, about the philosophy of Objectivism as it's taught through Ayn Rand's writings. Then we'll speak with Denise Cummins, cognitive scientist, author and fellow at the Association for Psychological Science, about the impact of Objectivist ideology on society. Related links: This is what happens when you take Ayn Rand seriously Another Critic Who Doesn’t Care What Rand Thought or Why She Thought It, Only That She’s Wrong Quote is from "A Companion to Ayn Rand"