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  1. Posted
    Categories
    • Research Integrity

    IQWiG Response to the EU TrialsTracker

    The EU TrialsTracker, which provides the results reporting status of every trial on the EU Clinical Trials Registry, launched last week alongside a paper in the BMJ. We already shared some of the media coverage from the launch of the tracker and comments from Norman Lamb MP, Chair of the House of Commons Science and Technology Committee and Fergus Sweeney, Head of Inspections, Human Medicines Pharmacovigilance and Committees at EMA.

    Today we wanted to share a statement, released on Friday, from the Institute for Quality and Efficiency in Health Care (IQWiG) in Germany. For those that are not familiar, IQWiG is the German institute responsible for assessing the quality and efficiency of medical interventions, similar to the role NICE plays in the UK. We were pleased to see a government institute calling explicitly for better results reporting from publicly-funded institutions. IQWiG offers frank experiences from their own work in which withheld data compromised their ability to properly assess the evidence for treatments under review. The director of IQWiG, Jürgen Windeler, specifically calls for a system that checks “whether an applicant has completely reported its previously funded project in the EU Register and, if applicable, refuse further funding.”

  2. Posted
    Categories
    • Research Integrity

    The EU TrialsTracker is Live!

    Earlier this year we launched our FDAAA TrialsTracker, providing a live look at whether individual sponsors and trialists are meeting their responsibility to report the results of clinical trials on ClinicalTrials.gov. Now we have launched the EU TrialsTracker. This new tracker shows the results status for every trial on the EU Clinical Trials Registry (EUCTR). We are launching the tracker alongside a paper in the BMJ providing a detailed overview of our methods, an analysis of the factors associated with non-reporting and a discussion of the data issues that make assessing compliance difficult on EUCTR.

  3. Posted
    Categories
    • TrialsTracker

    TrialsTracker Project Wins Cochrane-REWARD Prize for Reducing Research Waste

    Our FDAAA TrialsTracker has been updating each working day since February showing which trials on ClinicalTrials.gov have reported, in compliance with the FDA Amendments Act of 2007. Our newly launched EU TrialsTracker and paper in the BMJ show exactly which trials on the EUCTR have reported according to EU guidelines.

    This week we’re delighted to tell you that our TrialsTracker work has been awarded a Cochrane-REWARD Prize for Reducing Research Waste. We’re honored to share the 2nd prize with the wonderful James Lind Alliance; and further humbled to finish behind the mighty EQUATOR Network, who took a well-deserved 1st prize for their continued work on improving the quality of trial reporting.

  6. Posted
    Categories
    • OpenPrescribing

    Could North Cumbria save money on haemorrhoid cream?

    Last week, a pharmacist from NHS North Cumbria CCG got our attention by mentioning OpenPrescribing on Twitter. He had just received a letter about a product for treating haemorrhoids called Uniroid. It’s a 50/50 mixture of Cinchocaine and Hydrocortisone, and is also available as Proctosedyl (made by Sanofi), and as a generic (i.e. unbranded) product.

    The maker of Uniroid wants North Cumbria to start prescribing Uniroid-branded products, on the grounds it will save the CCG about £11,000 per year.

  7. Posted
    Categories
    • OpenPrescribing

    Smoothing seasonality - your feedback needed

    Recently we created antimicrobial stewardship dashboards for every Clinical Commissioning Group and General Practice in England by grouping our measures (see our blog post here).

    We received feedback from users that some of our measures are difficult to understand, because they exhibit a high level of seasonal variation. Antibiotics show the most seasonality amongst our measures (e.g. openprescribing.net/measure/ktt9_antibiotics). As you can see below, it takes a lot of staring at this graph to work out whether the deciles (blue lines) are going up or down overall, and whether the red line (the data from a single CCG) is changing in relation to them.

  8. Posted
    Categories
    • OpenPrescribing

    OpenPrescribing July 2018 newsletter

    This newsletter was sent out on Thurs, Jul 26; sign up to receive the next one at www.openprescribing.net

    We do the stats to make your life easy…

    At OpenPrescribing we hide complicated data science “under the bonnet”: we want data to be easy, to come alive and tap you on the shoulder when there’s a problem. As you know we have an “alerts” service, open and free to anyone, that emails you if there’s a new issue with the prescribing at any practice. But how does it all work? Making a tool that sends an alert when a practice hits the highest 10% in the country for a given prescribing measure was easy. But we wanted to spot problems and send alerts much sooner than that: when a practice begins to drift in comparison to its peers over time, well before it becomes an extreme outlier. Our most recent paper shows the inner workings of this service. If you’re really geeky, you can read the paper here. Or you can just sign up and use the service!

  9. 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.

  10. 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:

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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).

  17. 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:

  18. 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.