Skip to main content
Toggle menu

Search the website

TrialsTracker blog posts

  1. 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.

  5. 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.

  6. Posted
    Categories
    • Code

    COVID-19 TrialsTracker

    This repository contains the data cleaning notebook, all necessary datasets, and the code for running the COVID-19 TrialsTracker website at covid19.trialstracker.net. Docker files are included to ensure a consistent environment for reproducibility.

  7. 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
    • 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    Reporting Withdrawn Trials on the EUCTR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.

  10. Posted
    Categories
    • Policy Insights

    Science and Technology Select Committee Follows-Up on Trials Transparency

    Last week, the Commons Science and Technology Select Committee convened an inquiry following-up their previous clinical trials transparency efforts. The Select Committee has been very active in the trials transparency space over the past two years. Earlier this year they sent letters to every public university and NHS trust in the UK that sponsors clinical trials on the EU register. These letters reminded sponsors of their trial reporting responsibilities and provided them with reporting performance figures based on data from our EU TrialsTracker.

  11. Posted
    Categories
    • Policy Insights

    UK Trials and Brexit — An Update

    Earlier this year we noticed a disturbing trend among UK trials registered on the EUCTR. The amount of newly approved and registered trials on the EUCTR dropped drastically following the 2016 Brexit vote. The chart from that blog post (from May 2019) is included below.

    When we reached out to the MHRA to ask about this, they stated that there was actually no decline in UK trials post-Brexit but rather administrative delays that kept trials from appearing on the public-facing EUCTR website. They noted this issue was being addressed and updates would be completed by the end of Q2 2019.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. Posted
    Categories
    • TrialsTracker

    New Year Updates to the EU TrialsTracker

    Our EU TrialsTracker has been live for 4 months providing data on who is and isn’t meeting EU trial reporting guidelines. The tracker reached a major milestone last week when our data was used by the House of Commons Science and Technology Committee to inform UK Universities of their current reporting performance and remind them of their ethical and legal obligations to report their sponsored trials.

    As some of our regular users may have spotted, we’ve recently make some changes to the EU TrialsTracker. We wanted to take some time to describe these updates and let you know why we made them.

  17. 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.

  18. 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:

  19. 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.

  20. 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.

  21. 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.”

  22. 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.

  23. 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.

  26. 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.

  27. 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.

  28. 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:

  29. 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.

  30. 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.

  32. 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.

  33. 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.

  34. 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.”

  35. 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.

  36. 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.

  37. Posted
    Categories
    • TrialsTracker

    Publication Bias: in cake form - Bennett Institute at the Curiosity Carnival

    We were at Oxford University’s Curiosity Carnival, an event featuring researchers from all disciplines enthusiastically explaining their work to members of the public in an enormous variety of forms, all around the city.

    We entered the Great Research Bake-Off and took on the challenge of representing some of the key issues around research integrity through the medium of cake.

    We displayed an array of fairy cakes, each representing clinical trials. To produce a good cake, or trial, a good methodology is fundamental. And, of course, the results should be published in a paper (the icing on top); the outcome pre-specified (the colour of the case), and the same outcome reported (same colour flag). A plus or minus on top indicated a positive or negative result. However, only a small number of our cakes looked this good!

  38. Posted
    Categories
    • OpenPrescribing

    Bennett Institute 2016 Round-Up

    In our first full year of existence we’ve grown fast, recruiting lots of new staff. You can see us all on our new website: Lydia our project manager started in the Spring, as did Seb, our new coder; Lisa, our community engagement manager, started over the summer; Helen, our new researcher, started in December, with two more researchers starting in January. For our OpenPrescribing work we’ve been joined by Richard as our pharmaceutical advisor. We’ve also been lucky enough to pull in a huge team of excellent students including Jess, Sarah, Mark, and the mighty COMPare project team of Henry, Aaron, Ioan, Philip, and Eirion. We’ve now delivered some of our early projects, and have a nice portfolio of papers submitted already.