Bad results from drug trials no longer have a place to hide

“If you’re a huge company trying to develop a new drug or treatment, the temptation to hide ‘bad’ results might be a strong one. Until now, you would be able to hide those results with few consequences.” In this Wired article, Abigail Beall, discusses the Alltrials campaign and the FDAAA TrialsTracker

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OpenPrescribing February 2018 Newsletter

Price Concessions - starting to reduce? The latest price concession information for January has been released by the PSNC (in fact, two sets of data in quick succession). The PSNC have also stated that they are “still in discussion with the DHSC regarding further January 2018 price concessions”. Therefore we have made some calculations based on what we know at the moment - as soon as there are changes we will update this blog.

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Unreported Trial of the Week: NCT01846221

With the launch of our FDAAA TrialsTracker, applicable trials that have failed to report their results on ClinicalTrials.gov are starting to appear. If you go here on our Tracker (the “All Trials” view, and toggle the “due” filter) you can see all the trials that have not yet reported. Non-reporting of clinical trial results in an ongoing, global public health issue. We are going to start highlighting some of these unreported trials in blog posts to shine a light on what information is being withheld from the public as a result of non-reporting.

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Making the FDAAA TrialsTracker even better than current ClinicalTrials.gov data

When you produce online tools from data, you often get useful feedback that helps you improve the outputs. (Send us feedback any time!). Additionally, when you use data, you learn about interesting glitches in it, some of which can be entirely undocumented. Here we share one example of helpful feedback, and how we used it to improve our tool. First some background. Trial reporting is a huge problem in medicine: the results of clinical trials are routinely withheld from doctors, researchers, and patients.

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Why is this trial due to report?

Now that we’ve launched our FDAAA TrialsTracker, we plan on occasionally taking a closer look at some of the trials that go unreported. Our first blog was about a trial examining 2 drug combinations for managing pain during labor (NCT01846221). So why do we think this specific trial is due to report? While we go through how we established our criteria and set up our database in detail in our preprint paper on Biorxiv, we wanted to walk you through exactly what fields matter on ClinicalTrials.

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Tool 'names and shames' hidden drug trials

“Institutions that fail to report the results of their drug and medical trials will be named on a new website.” In this BBC article, Chris Foxx, highlights the FDAAA TrialsTracker. Quoting Bennett Institute Director, Ben Goldacre, “I’m not interested in naming and shaming people in order to criticise them. This project is being done to nudge institutions to prioritise trial reporting.”

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The FDAAA TrialsTracker is Live!

This week, we launched our FDAAA TrialsTracker which gives you a live look at whether individual sponsors and trialists are meeting their responsibility to report the results of clinical trials on ClinicalTrials.gov. A lot of work went into the tracker and making sure we got it right. You can read all about our methods, in detail, here but the short version goes like this… Certain trials registered on ClinicalTrials.gov, the US trial registry run by the National Institutes of Health (NIH), are required to report their results.

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Price Concessions - starting to reduce? UPDATED

The latest price concession information for January has been released by the PSNC (in fact, two sets of data in quick succession). The PSNC have also stated that they are “still in discussion with the DHSC regarding further January 2018 price concessions”. Therefore we have made some calculations based on what we know at the moment - as soon as there are changes we will update this blog. UPDATE: We’ve now updated the data, both with the final concessions list for January 2018, and the actual cost data for December 2017.

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Omega-3 isn't very effective: using prescribing data to explore the impact of trials, reviews, and guidelines

We’ve been thinking in the Bennett Institute about doing stories, using our prescribing data, to go with landmark clinical trials and systematic reviews. Here’s an example. A new systematic review published this week in JAMA shows that Omega-3 “fish oil” pills don’t really help improve cardiovascular health. As a systematic review, it’s a very useful overview of previous existing research. Perhaps reassuringly, as that evidence accumulated over time, clinicians were already changing their prescribing behaviour.

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