Most often, reporting on medical studies means recounting numbers, demographic details, findings and statistical probability values that are so abstract that it’s easy to forget they all refer to actual people enrolled in the study. With epidemiological studies, the researchers themselves often never meet the people they report on, especially if it’s a retrospective study that primarily relies on electronic medical records.
But clinical trials are a different story. Continue reading
You may have recently heard about the multimillion-dollar donation that Bill Gates and Leonard Lauder made to support research into biomarkers for early detection of Alzheimer’s disease and related dementias.
The Diagnostics Accelerator initiative is part of the Alzheimer’s Drug Discovery Foundation’s (ADDF) effort to speed diagnosis and develop drugs that can prevent, treat, and cure the disease. Lauder was an ADDF co-founder. Continue reading
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
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.
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
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)