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  1. Posted
    Categories
    • TrialsTracker

    FDAAA TrialsTracker Milestones: 6 Months, >1200 trials, $500 Million in Fines

    On February 19, 2018 we launched the FDAAA TrialsTracker, a tool that automatically monitors whether clinical trials are reporting their results to ClinicalTrials.gov in accordance with US law. We bring public accountability by ranking sponsors, and help researchers to comply with the law by showing them which of their trials are overdue. We also calculate the total fines the FDA could have imposed to date on non-compliers.

    This week marks two important milestones for the FDAAA TrialsTracker. Firstly, it’s six months since we first launched (and 6 months since the first trials came due under the “Final Rule” of the FDA Amendments Act). Secondly - coincidentally - we’ve just hit the $500,000,000 mark in unclaimed fines for the FDA.

  2. Posted
    Categories
    • OpenPrescribing

    New on OpenPrescribing — our measures now have categories!

    Update: You can view a short Youtube video demonstrating this feature here.

    On our OpenPrescribing CCG and practice dashboards you can now filter measures by category to view a small group of related measures together.

    You can select a category using the new dropdown menu above the measures…

    …Or by clicking on a category listed at the bottom of the description of a measure.

    Upon selecting a category you’ll see its description / rationale above the measures:

  3. Posted
    Categories
    • OpenPrescribing

    OpenPrescribing June 2018 Newsletter

    Updates to OpenPrescribing

    Thanks largely to our new software developer Dave, we are making some improvements to the site.

    With the fresh-faced enthusiasm of a new starter, Dave has begun by tackling the various not-so-exciting but still important tasks which we’ve put off doing for ages. These changes are mostly behind the scenes, but you should hopefully notice that the site feels a bit snappier to browse. One of the changes which you can see is that we now clearly label on the site where a practice has closed or become dormant. Due to the way prescribing data is collected, practices can appear to continue prescribing for several months after they become dormant, and so we now flag this up and explain what is happening.

  4. Posted
    Categories
    • OpenPrescribing

    OpenPrescribing May 2018 Newsletter

    Low-Priority Prescribing Paper Published

    This week our latest paper was published, which describes the trends and variation in prescribing of medicines determined to be of “low-priority” by NHS England. We found that there has been an overall decrease in the prescribing volume of these medications, but despite this, costs have risen slightly. This is driven by higher costs per prescription for drugs such as liothyronine, trimipramine and coproxamol. You can see how much your practice/CCG spends on these items using our measure.

  5. Posted
    Categories
    • OpenPrescribing

    "PPPI": why academics should engage Patients, the Public *and* Professionals

    This is a brief blog about something small and trivial, but also big and important.

    Recently on the staircase my friend Carl Heneghan came out with a good line about “Patient and Public Involvement”, or “PPI” as it is known in the trade. “People talk about PPI,” he said: “but we need PPPI… patients, the public, and professionals.”

    I think this is absolutely correct. In academia, we often fail to focus on what happens at the coalface. In the Bennett Institute we’ve worked hard to change that. We take conventional academic funder money, and health data, and we produce conventional academic papers (by the shovel-load). But we also turn that data and person-time into live, interactive, data-driven tools like OpenPrescribing.net which people can hold in their hands, and use at the coalface to improve patient care.

  6. Posted
    Categories
    • OpenPrescribing

    OpenPrescribing April 2018 Newsletter

    Homeopathy Paper Published

    Our new paper asks the question: Is use of homeopathy associated with poor prescribing in English primary care? The answer, yes. We found that general practices that have worse than average prescribing scores on our standard measures were more than twice as likely to prescribe homeopathy than practices with better than average scores. Interestingly, the level of homeopathy prescribing we found is quite low and is decreasing quite quickly.

  7. Posted
    Categories
    • TrialsTracker

    Unreported Clinical Trial of the Week Round-Up

    In February, we posted our first Unreported Trial of the Week here in the Bennett Institute blog highlighting a trial from Columbia University. Since then, that trial has submitted results to ClinicalTrials.gov and Unreported Trial of the Week has moved to the BMJ!

    Each week we profile a new unreported clinical trial that has not reported results in accordance with their legal requirements. You can see all four trials we have profiled thus far as well as the introductory post at the BMJ. A short summary and a link to each of the first four trials is provided below.

  8. Posted
    Categories
    • OpenPrescribing

    OpenPrescribing March 2018 Newsletter

    Price Concessions - February

    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 available at time of writing), and is therefore likely to reduce slightly (as February has fewer days).

  9. 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:

  10. 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.

  11. 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.

  12. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.”