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  1. Posted
    Categories
    • TrialsTracker

    An unreported clinical trial… from the FDA themselves

    Our FDAAA TrialsTracker provides a public list of all trials required to report under the FDA Amendments Act of 2007 (FDAAA). We update every weekday with live data showing who has, and has not, reported their results in accordance with the law. You can read our full methods in our preprint paper.

    One unreported trial last week stood out: this trial was sponsored by the FDA, the agency in charge of enforcing the reporting requirements of the FDAAA. We raised this in public; journalist Ed Silverman, from Pharmalot at STAT, picked up the story and contacted the FDA. He wrote about the trial in STAT, where a spokesperson for the FDA provided the following statement:

  2. Posted
    Categories
    • OpenPrescribing

    Price concessions for February 2018

    The Pharmaceutical Services Negotiating Committee (PSNC) have released 3 sets of price concession price lists for February 2018. Once again, the total amount for England for the month has reduced: we’ve estimated the impact as £9.37 million for February 2018, although this is based on December 2017 data (the latest we have), and is therefore likely to reduce slightly (as February has fewer days).

    The total for 2017-18 so far is £308.7 million, although the further impact is probably greater as some formerly low-cost generics are not considerably more expensive. For example levetiracetam 1g tablets, used in epilepsy, were £5.49/60 in July 2017, and in January 2018, following a spell as a price concession, increased to £36.07/tablets.

  3. Posted
    Categories
    • Open Working

    Welcoming our new Bennett Institute team member, Darren Smyth: a lawyer!

    Here at the Bennett Institute we are a truly multidisciplinary team: clinicians, academics and software engineers, working together to produce tools, as well as papers.

    This is glorious fun, and productive. From our time working together as a team we now have software engineers who know about clinical trials, prescribing data, and more; and we have researchers and clinicians who know a bit about building websites.

    This may or may not thrill you, but I will share it: our academics write code that runs live on our websites! In addition, our team can be creative, because we all know a little about each others’ work: about what is possible with software and data, and what kinds of problem need solving in medicine.

  4. Posted
    Categories
    • TrialsTracker

    Our FDAAA TrialsTracker is already helping to get new trials reported!

    When we launched our FDAAA TrialsTracker we wanted to produce a tool that would improve clinical trial reporting, rather than another repetitive academic journal paper that simply documents the extent of the problem. This reflects our ethos in the Bennett Institute: clinicians, academics and software engineers, working together to produce tools, as well as papers.

    Two weeks after launch we have had extensive media coverage, and a lot of great user feedback. Here are two emails we’ve had from users who are employed to improve clinical trial reporting in major US institutions.

  6. Posted
    Categories
    • OpenPrescribing

    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. For January 2018, on the surface price concessions look better than in previous months, with an estimated impact of about £12.6 million. This brings the total for the financial year to date to approximately £297 million. This is based on an estimated actual cost, using November data for December and January, so there will be slight changes when the actual data is available.

  7. Posted
    Categories
    • Research Integrity

    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.

  8. Posted
    Categories
    • TrialsTracker

    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. We think all trials should be reported. The WHO agrees. A US law called the FDA Amendments Act requires some trials to report their results on ClinicalTrials.gov: this law has many loopholes, but it’s an important start. Since the results reporting requirements of FDAAA came into full force, our FDAAA TrialsTracker has been identifying the individual trials that have breached it. You can read our paper on how the tool works: we also blogged about our methods for identifying overdue trials. Staff in universities who manage trial reporting are already telling us that they find our tool useful.

  9. Posted
    Categories
    • Policy Insights

    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.gov and how we used them to build our tracker. We think we were able to do this well, but are open to feedback and will amend our paper and methods as necessary.

  10. Posted
    Categories
    • TrialsTracker

    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.”

  11. Posted
    Categories
    • TrialsTracker

    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. This requirement began with the passing of the FDA Amendment Act of 2007 (FDAAA) but different interpretations of the broad requirements laid down under FDAAA led to some confusion over who was required to report and when. In September of 2016, a “Final Rule” was published by the NIH that clarified and expanded how the reporting requirement under FDAAA would operate moving forward. The Final Rule came into effect on January 18, 2017.

  12. Posted
    Categories
    • OpenPrescribing

    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.

  13. Posted
    Categories
    • OpenPrescribing

    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. Here’s the long-term NHS prescribing data from our database: NHS doctors gradually began to reduce prescribing of omega-3 a long time ago. Peak omega-3 was 2011!

  14. Posted
    Categories
    • OpenPrescribing

    OpenPrescribing January 2018 Newsletter

    New Year - same Price Concessions issues…

    Everyone at the Bennett Institute wishes you a very Happy New Year!

    Unfortunately, the NHS is still having the same problems in sourcing generics. The PSNC announced the latest list of price concessions for December 2017, slightly smaller than November’s, with 86 lines. However, we still estimated a monthly impact for the NHS in December of £27 million, bringing the total excess cost for the nine months to December to £285 million:

  15. Posted
    Categories
    • OpenPrescribing

    New Year - same Price Concessions issues…

    Everyone at the Bennett Institute wishes you a very Happy New Year!

    Unfortunately, the NHS is still having the same problems in sourcing generics. The PSNC have just announced the latest list of price concessions for December 2017. The list was slightly smaller than November’s, with 86 lines,but we are still estimating an monthly impact for the NHS in December of £27 million. This brings the total excess cost for the nine months to December to £285 million:

  16. Posted
    Categories
    • OpenPrescribing

    Trends and variation in gluten-free food prescribing

    Many people I’ve spoken to aren’t aware that gluten-free foods can be prescribed, but it happens quite extensively in an effort to help patients with coeliac disease adhere to a gluten-free diet.

    Below is a chart showing the rate of gluten-free product prescribing since 1998, where there is a gradual increase until 2011, when guidance changed to recommend only prescribing of staple foods such as bread and flour. Recently there has been a sharper decline.

  17. Posted
    Categories
    • Open Working

    2017 Round-Up

    In our second full year of existence we produced even more exciting outputs and continued to grow. You can see the team on our website: Emma-Jane has been our project manager since the Spring; we have two new part-time coders working for us; and researchers Alex, Nick, Daniel and Karolina all started this year. We’ve delivered a range of great new features on OpenPrescribing, got great progress on numerous pre-launch projects, and have a nice portfolio of papers submitted.

  18. Posted
    Categories
    • OpenPrescribing

    Price Concessions - why are the excess costs lower in November than October 2017?

    We’ve taken a quick look at the data to see why, despite the number of price concession lines have increased to 91 in November, the estimated total excess cost has reduced. (Reminder - we’ve used September prescribing data to estimate the effects, as that’s the latest data available).

    The full table is below, but here are some highlights:

    1. Some of the price concessions have reduced since October. For example, olanzapine 10mg tabs have dropped considerably, from £62/box to under £27/box - although the tariff price has increased from just over £1/box at the beginning of the year. The same applies for gabapentin and amlodipine 10mg tablets.
    2. Some items, such as pramiprexole 88mcg tablets have been removed as a price concession, although once again the tariff price has increased significantly.
    3. Although there are eight new chemicals listed in price concessions, these haven’t a huge impact: topiramate being the largest new cost pressure at around half a million pounds estimated in November.

    As always, you can find our Drug Tariff viewer at www.openprescribing.net/tariff. We’d love to know what you think about the work we’re doing, or anything to do with the OpenPrescribing tool. Please let us know on Twitter, our Facebook page, or via email at feedback@openprescribing.net.