Tag Archives: Clinical Trials

NIH to require more transparency for clinical trials

About Tara Haelle

Tara Haelle (@TaraHaelle) is AHCJ's medical studies core topic leader, guiding journalists through the jargon-filled shorthand of science and research and enabling them to translate the evidence into accurate information.

Photo: Iwan Gabovitch via Flickr

The ongoing push for open science and greater transparency in medical research just notched another win following new rules from the National Institutes of Health regarding federally funded research involving humans. As the Wall Street Journal recently reported, the NIH is broadening the definition of clinical trials for what must be registered and reported at ClinicalTrials.gov.

“Researchers must now report their findings on the site within a year of study completion or risk losing future funding,” wrote reporters Daniela Hernandez and Amy Dockser Marcus. Continue reading

Stat details failure of research institutions to submit required study reports

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates AHCJ's social media efforts and edits and manages production of association guides, programs and newsletters.

Photo: Lydia Polimeni, National Institutes of Health via Flickr

Photo: Lydia Polimeni, National Institutes of Health via Flickr

A Stat investigation has found that “prestigious medical research institutions have flagrantly violated a federal law requiring public reporting of study results, depriving patients and doctors of complete data to gauge the safety and benefits of treatments.”

The violations have left gaping holes in a federal database used by millions of patients, their relatives, and medical professionals, often to compare the effectiveness and side effects of treatments for deadly diseases such as advanced breast cancer.

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Drug company takes a stand in fight for clinical trial transparency

About Brenda Goodman

Brenda Goodman (@GoodmanBrenda), an Atlanta-based freelancer, is AHCJ’s topic leader on medical studies, curating related material at healthjournalism.org. She welcomes questions and suggestions on medical study resources and tip sheets at brenda@healthjournalism.org.

Making drug capsules in small volume for a clinical trial, for an unnamed pharmaceutical company.

Image by Esthr via flickr.

Efforts to increase the transparency and accessibility of clinical trial data kicked into a higher gear last week.

Some of the major stakeholders in these efforts emerged wearing white hats, while others had more shadowy motives revealed.

First, the good news: GlaxoSmithKline (GSK) announced, in the New England Journal of Medicine, that it has begun to release de-identified patient-level data from its clinical trials.

So far, 200 studies have been added to a new website, with another 200 coming by year’s end, according to the report. And there will be further updates beyond that.

To access the raw data, GSK is asking researchers to submit a proposal, which will also be published on the website. They’re also asking researchers who want access to their data to post summary results on the website and seek publication of their work, “in line with standard scientific practice.” Continue reading

AHCJ members contribute tips on best uses of ClinicalTrials.gov

About Ivan Oransky, M.D.

Ivan Oransky, M.D., president of AHCJ's board of directors, is vice president, editorial, at Medscape and a Distinguished Writer In Residence at New York University’s Arthur L. Carter Journalism Institute. He blogs at Embargo Watch and at Retraction Watch. Follow him at @IvanOransky.

Medical reporters are likely familiar with ClinicalTrials.gov, the U.S. government-run registry of clinical trials. The site became available in 2000, three years after Congress passed the Food and Drug Administration Modernization Act of 1997 (FDAMA), which, as the site notes,

required the U.S. Department of Health and Human Services, through NIH, to establish a registry of clinical trials information for both federally and privately funded trials conducted under investigational new drug applications (IND) to test the effectiveness of experimental drugs for serious or life-threatening diseases or conditions.

The site – and others around the world – really took off in 2005 after the International Committee of Medical Journal Editors began requiring that researchers register their trials when they started if they wanted to publish the results. Publishing in the peer-reviewed literature is the coin of the realm in academia and also vital for FDA approval, so the carrot worked, according to a 2007 update:

Before the ICMJE policy, ClinicalTrials.gov, the largest trial registry at the time, contained 13 153 trials; this number climbed to 22 714 one month after the policy went into effect (3). In April 2007, the registry contained over 40 000 trials, with more than 200 new trial registrations occurring weekly (Zarin D. Personal communication).

Registration of a trial’s plans – what researchers plan to test, and how – also means there’s a pixel trail if reporters, or any member of the public, wants to see if scientists changed the goalposts to make their results look better, or buried negative results. (Also see Ghost protocols: Scientists propose a way to plug major holes in the medical literature)

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Patients “blood doping” to get into trials

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

Like professional sports, cancer trials can be competitive, for both patients and researchers. And, also like professional sports, the competitors are apparently doing anything they can to get an edge, as MedPage Today’s Crystal Phend writes in a story about patients using “blood doping” to get into clinical trials.

Phend points to a NEJM letter which references three different patients who relied on blood transfusions to become eligible for trials of new chemotherapy agents. Naturally, Phend writes, this is not advisable.

Clinicians should try to correct the underlying laboratory value through other treatments first, such as treating anemia, they urged. Explore all possible other options, including looking for other trials at other institutions for patients who don’t meet eligibility criteria, they added.

“Patient safety must trump all decisions for such patients,” the group concluded. “There should be few situations, if any, in which a patient receives a transfusion solely for the purpose of temporarily altering a laboratory value to gain admittance to a clinical trial.”

The authors also recommend that publications disclose the number of patients in each trial who required blood transfusions to meet eligibility requirements.