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Research Integrity blog posts

  2. Posted
    Categories
    • Research Integrity

    The FDAAA TrialsTracker is Back Online!

    After a bit of a hiatus, the FDAAA TrialsTracker is back with nerdy details about what went wrong and how we fixed it.

  4. Posted
    Categories
    • Research Integrity

    First Impressions of the EU CTIS Registry

    The Clinical Trial Information System (CTIS) is the European Union’s new registry set to fully replace the existing EU Clinical Trials Registry next year. Nick DeVito decided to take a spin through the registry and record some of his initial thoughts.

  5. Posted
    Categories
    • Open Working

    OpenPrescribing Newsletter: July 2020

    New papers on hospital medicines data, NHS analytics and statin prescribing, alongside updated CCG dashboards and OpenSAFELY COVID-19 research.

  6. Posted
    Categories
    • Open Working

    OpenPrescribing Newsletter: June 2020

    New research on unsafe methotrexate prescribing, bespoke prescribing email alerts, and analysis of COVID-19’s impact on prescribing in March 2020.

  7. Posted
    Categories
    • Open Working

    OpenPrescribing Newsletter: May 2020

    Introducing OpenSAFELY, COVID-19’s early impact on prescribing, rising price concession costs, and bespoke PCN email alerts.

  8. Posted
    Categories
    • Open Working

    Bennett Institute – What We Did Last Year!

    Most people share their end of year roundup during late December when everyone is too full of cake to read. Now you’re back in the saddle, here’s our roundup of everything the Bennett Institute threw out into the world over the previous 12 months!

    OpenPrescribing

    OpenPrescribing.net went from strength to strength, with over 135,000 unique users last year. We now have over 80 measures of prescribing safety, efficacy and cost-effectiveness and have been working on new types of measures and alerts to identify “outlier” prescribing, such as with zuclopenthixol. In 2019 we also: launched new dashboards and bespoke alerts for every single primary care network (PCN), sustainability and transformation partnership (STP), and NHS region; upgraded the Analyse page to support more organisations with bespoke medicines queries; and developed tools to help solve the problem of Ghost Branded Generics which cost the NHS an extra £11.6million per annum but has massively reduced during 2019.

  9. Posted
    Categories
    • Open Working

    OpenPrescribing Newsletter: November 2019

    PCN dashboards go live, research examines clinical software and prescribing safety, and a guest blog explores high-dose dexamethasone.

  10. Posted
    Categories
    • Policy Insights

    Reporting Withdrawn Trials on the EUCTR

    Our EU TrialsTracker has been assessing compliance with EU trial reporting guidelines for over a year now. Our data has been used by Parliamentary Committees and trial sponsors to improve the reporting of clinical trials registered on the EU Clinical Trials Register (EUCTR).

    We previously shared some of the data issues that make complete assessments of trials on the EUCTR difficult. One particularly troubling issue is dealing with trials that never began. Sometimes trials get all the necessary approvals to begin, and therefore are automatically registered on the EUCTR. In rare instances, and for any number of reasons, they then simply never begin; they are cancelled before they enroll a single participant or collect any data. Obviously, these trials have no results to report.

  11. Posted
    Categories
    • Open Working

    OpenPrescribing Newsletter: October 2019

    New inhaler environmental impact and seven-day prescribing measures, research on prescribing changes, and expanded data downloads.

  12. Posted
    Categories
    • Open Working

    OpenPrescribing Newsletter: September 2019

    Links from prescribing measures to the Analyse page, improvements to the price-per-unit savings tool, and preparations for PCN dashboards.

  13. Posted
    Categories
    • Open Working

    OpenPrescribing Newsletter: Summer 2019

    The launch of the NHS dm+d browser, lower thresholds for price-per-unit savings, and price concession dashboards for STPs and regional teams.

  14. Posted
    Categories
    • Open Working

    OpenPrescribing Newsletter: June 2019

    New low-priority prescribing measures and All England email alerts, alongside Analyse page improvements and plans for Primary Care Network dashboards.

  15. Posted
    Categories
    • Open Working

    OpenPrescribing Newsletter: May 2019

    Research on variation in adopting UTI prescribing guidance, user testing for regional and STP dashboards, and preparations for newly merged CCGs.

  16. Posted
    Categories
    • Policy Insights

    UK Trials and Brexit

    We recently noticed a very dramatic drop in the number of UK clinical trials post-Brexit on the EU Clinical Trials Register (which would be a catastrophe for British science) and wrote to MHRA to get their view. It turns out that the drop is largely due to bad data management: this is worrying, but not the same thing as a drop in the number of UK clinical trials.

    The Short Story

    We’ve been conducting research on trends in clinical trials globally with one very striking recent finding: examining clinical trials on medicinal products, using the EU Clinical Trials Register (EUCTR), the number of trials with a competent authority decision from the UK has fallen dramatically. As you can see on the graph below: from a long-term trend of around 150 new trials per quarter, after 2016 there is a rapid drop to fewer than 50, and now fewer than 10.

  17. Posted
    Categories
    • Open Working

    Openness and Transparency: why is openness and transparency important for good data analysis and how does OpenPrescribing embody it?

    At the Bennett Institute we value openness and transparency as we believe open discussion of ideas and methods are the key ingredients for high quality data analysis. We think it is unhelpful that so much NHS data analysis is outsourced, or done behind closed doors. This blog sets out the steps we take with OpenPrescribing.net to ensure all our analysis and methodology is freely available for inspection, review, and importantly re-use, by anyone. We hope other teams will adopt these approaches so we can all collaborate to optimise analysis, generate insights and improve care for patients in the NHS.

  18. Posted
    Categories
    • Research Integrity

    FDAAA TrialsTracker: Milestones and Methodology Updates

    It’s been a busy start to the year for the FDAAA TrialsTracker! As the FDAAA TrialsTracker celebrates its 1 year anniversary, we now show over 1000 trials currently overdue to report under the FDA Amendments Act of 2007 (some background on our tracker and the FDAAA 2007 here). Additionally, we estimate that the FDA could have collected over $2 billion in fines if they were enforcing these requirements. To date, we have no evidence they have issued even a single dollar in fines. But along with the bad comes the good. Over the past year we’ve also heard from many trial sponsors and other organisations and individuals who are using our TrialsTrackers to ensure trials are reported on time and in accordance with the law.

  19. Posted
    Categories
    • Open Working

    OpenPrescribing Newsletter: February 2019

    New price concession email alerts, a guide to finding prescribing cost savings, and improvements to measure breakdowns and Analyse page totals.

  20. Posted
    Categories
    • Policy Insights

    Retracted RCTs and clinical guidelines

    As you know, here at the Bennett Institute we are working on the RetractoBot project to reduce the number of cited retracted papers.

    Citations of retracted RCTs are particularly dangerous because such trials provide strong and unbiased evidence of treatment’s safety and efficacy (hierarchy of evidence). Moreover, results of RCTs are often pooled in systematic reviews and meta-analyses, which are used to synthesise the available evidence on a given subject or to justify clinical guidelines.

  21. Posted
    Categories
    • Research Integrity

    Trial Reporting at NHS Trusts in England

    Nearly all trials of medicinal products conducted in Europe since 2004 are required to post their results directly onto the EU trials register within one year of completion. Since September, our EU TrialsTracker has monitored all clinical trials in the EU to check whether they are compliant. Recently we produced a specific report on data on trial reporting at UK Universities: the House of Commons Science and Technology Committee is currently using this data to alert Universities and monitor their current reporting performance.

  22. Posted
    Categories
    • Research Integrity

    Science and Technology Select Committee Chair Uses EU TrialsTracker Data in Letters to UK Universities

    Yesterday, we shared an overview of trial reporting performance for all UK Universities on our EU TrialsTracker and FDAAA TrialsTracker. Today, we are pleased to see this data being put to good use.

    Following-up on the October 2018 report on clinical trials transparency, the chair of the House of Commons Science and Technology Committee, Norman Lamb MP, has sent letters to 41 universities with trials registered on the EU Clinical Trials Register (EUCTR).

    The letter reminds each institution of their trial reporting responsibilities under EU and US law. It gives them their current reporting performance, taking current figures directly from our EU TrialsTracker (BMJ paper here). It asks each university to verify that systems are in place to ensure compliance with these requirements, and opens the possibility that continued poor performance could lead to being called in front of the committee in the near future.

  23. Posted
    Categories
    • Research Integrity

    Trial Reporting at UK Universities

    Our EU TrialsTracker has now been live for four months. As of 10 January 2019, we have identified 8,062 trials registered in Europe that are unambiguously due to report results under EU guidelines; a total of 4,323 (53.6%) trials have reported results to the registry. We have also seen some institutions — for example Kings College London — improve their trial reporting performance dramatically and rapidly.

    Our BMJ paper showed that non-commercial sponsors (mostly universities) were substantially worse at reporting results to the registry, when compared with drug companies. The House of Commons Science and Technology emphasised this worrying finding in their October 2018 report on clinical trials transparency:

  24. Posted
    Categories
    • OpenPathology

    2018 Round-Up

    In our third full year of existence we produced even more exciting outputs and continued to grow. We welcomed Lydia Berry, back from maternity leave; Dave Evans, Consultant Programmer, who joined the OpenPrescribing technical team; and Brian MacKenna, an Honorary Research Fellow Pharmacist and member of the NHS England Medicines and Diagnostics Policy Unit. We also welcomed Darren Smyth, a UK and European Patent Attorney - our work so far includes our pregabalin papers (here and here), and he has also contributed to our EUCTR work.

  25. Posted
    Categories
    • Research Integrity

    New Lawsuit Against US Government Cites FDAAA Tracker

    Earlier this week, the Media, Freedom & Information Access Clinic at Yale Law School filed a lawsuit against the heads of the Department of Health and Human Services, the NIH, and the FDA over their interpretation and implementation of trial reporting provisions in the FDA Amendments Act of 2007 (FDAAA 2007). The lawsuit was filed on behalf of Charles Seife, a journalist and NYU professor, and Dr. Peter Lurie, President of the Center for Science in the Public Interest.

  26. Posted
    Categories
    • OpenPrescribing

    OpenPrescribing Newsletter: December 2018

    New measures for NHS England’s proposed do-not-prescribe list, a planned price concessions calculator, and prescribing data limitations.

  27. Posted
    Categories
    • OpenPrescribing

    OpenPrescribing Newsletter: October 2018

    The launch of the All England dashboard, support for responding to phenytoin supply disruption, and tools for antimicrobial stewardship.

  28. 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.”

  29. 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.

  30. 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.