OpenTrials : all available information on all clinical trials

The project aim to use a broader range of techniques and attempt to match a very large quantity of information on all trials

Abstract

OpenTrials: towards a collaborative open database of all available information on all clinical trials, BiomedCentral, 8 April 2016.

OpenTrials is a collaborative and open database for all available structured data and documents on all clinical trials, threaded together by individual trial. With a versatile and expandable data schema, it is initially designed to host and match the following documents and data for each trial: registry entries; links, abstracts, or texts of academic journal papers; portions of regulatory documents describing individual trials; structured data on methods and results extracted by systematic reviewers or other researchers; clinical study reports; and additional documents such as blank consent forms, blank case report forms, and protocols. The intention is to create an open, freely re-usable index of all such information and to increase discoverability, facilitate research, identify inconsistent data, enable audits on the availability and completeness of this information, support advocacy for better data and drive up standards around open data in evidence-based medicine. The project has phase I funding. This will allow us to create a practical data schema and populate the database initially through web-scraping, basic record linkage techniques, crowd-sourced curation around selected drug areas, and import of existing sources of structured and documents. It will also allow us to create user-friendly web interfaces onto the data and conduct user engagement workshops to optimise the database and interface designs. Where other projects have set out to manually and perfectly curate a narrow range of information on a smaller number of trials, we aim to use a broader range of techniques and attempt to match a very large quantity of information on all trials. We are currently seeking feedback and additional sources of structured data.

Background

Trials are used to inform decision making, but there are several ongoing problems with information management on clinical trials, including publication bias, selective outcome reporting, lack of information on methodological flaws, and duplication of effort for search and extraction of data, which have a negative impact on patient care. Randomised trials are used to detect differences between treatments because they are less vulnerable to confounding, and because biases can be minimised within the trial itself. The broader structural problems external to each individual trial result in additional biases, which can exaggerate or attenuate the apparent benefits of treatments.

Conclusions

OpenTrials paper published, OpenTrials Blog, 2016/04/12.

We are building an open free database and web service to identify, aggregate, store, match, index and share all available documents and data on all clinical trials. We are keen to receive feedback on the current methods, design, and data schema; feature requests; offers or suggestions of further data sources; and collaborations or methods to expand or improve the specification. Progress can be viewed at OpenTrials.​net where the service will be hosted.

CEBM All Trials session

Ben Goldacre on the importance of the All Trials campaign

Introduced by Sir Iain Chalmers, Ben Goldacre, Sile Lane and Carl Heneghan voice the importance of AllTrials.

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The placebo effect

The amazing power of the mind over the body

Ben Goldacre, doctor and author of Bad Science and Bad Pharma, explains what the placebo effect is and describes its role in medical research and in the pharmaceutical industry.

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Imagining the Future of Medicine

Ben Goldacre was speaking in the home of the BBC Proms on recent progress in promoting transparency in clinical trials

As part of its mission to promote access to the arts and sciences, the Royal Albert Hall hosted an historic event on Monday 21 April 2014, curating a spectacular and provocative programme of talks from world experts celebrating innovation, imagination, inspiration and their passion for a better future in health and medicine.

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  • Ben Goldacre, former TED and TEDMED speaker, is a doctor, academic, campaigner and bad science writer whose work focuses on uses and misuses of science and statistics. He is the founder of the All Trials campaign and a keen advocate for clinical transparency.
  • Video published on 10 Jun 2014 by Royal Albert Hall.
  • Watch more research videos on @DES_Journal YT channel.

Ben Goldacre discusses Clinical Data Transparency at the Clinical Data Live!

Quanticate hosted a free symposium, which took place at the Royal College of Surgeons, September 2013

Dr Ben Goldacre, author of ‘Bad Pharma‘ presented a keynote speech at the Clinical Data Live! symposium. In this video hear Ben Goldacre present ‘ALLTrials: Transparency is moving forwards, industry can benefit from doing the right thing‘. This symposium was hosted by Quanticate who support Pharma and Biotech companies with statistical consultancy services.

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A December 2014 Interview with Dr Ben Goldacre

Meet the anti-Dr Oz, by Julia Belluz, Vox health reporter

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Understand the news with Vox ; meet Ben Goldacre via their health reporter Julia Belluz.

You might have read few posts here about Dr Ben Goldacre, but none of them really addressed those questions:

  • You’re a busy doctor and researcher. Why did you start writing?
  • Going back through the collected works, it was quite clear that popular media outlets gave you space to be pretty nerdy about statistics and research methods, which is uncommon in health writing today.
  • Over a decade, you’ve debunked everything from ear candling to the anti-vaccine movement, and poorly designed education and health policies. Have you seen any progress?
  • Vaccine denialism remains stubbornly in place. Why do you think that is?
  • What you seem to be saying here is that it is pretty difficult to fight quacks with science?
  • But you’re the guy who got your dead cat the same certificate as a famous British nutritionist just to demonstrate how bogus her credentials were. Didn’t you hope that your work would have an impact on shutting down quack enterprises?
  • What does this irrational thinking about health suggest about the kinds of policies we should make?
  • Big Pharma, and some of the harmful impact it has had on health and science, has been another key target of yours. What are the biggest pharma boondoggles going on right now?
  • You’ve been trying to address that problem — of the broken information architecture of medicine — with your AllTrials campaign. How’s that going?

Read Meet the anti-Dr. Oz: Ben Goldacre, by Julia Belluz, health reporter for Vox, December 27, 2014.

2014 Cosmic Genome Science Advent Calendar

Here is 2014 with Dr Ben Goldacre

From a successful year for the All Trials campaign, to new book ‘I Think You’ll Find It’s a Bit More Complicated Than That‘, here’s 2014 with Dr Ben Goldacre.

Are Clinical Trials important? What do they involve?

A clinical trial is a particular type of clinical research that compares one treatment with another. It may involve patients or healthy people, or both

In this video, EFPIA Director General Richard Bergström explains why clinical trials are important, what they involve.

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It is Time to Make Clinical Trials Count!

All trials past and present should be registered, and the full methods and the results reported

It is time all clinical trial results are reported. Results from around half of clinical trials have never been published. Information on what was done and what was found in these trials could be lost forever to doctors and researchers, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated. The contributions of the hundreds of thousands of patients who took part in those trials remain unused and unusable.

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Pharma Industry fear a Boycott more than anything else

” I don’t think industry are concerned about patient confidentiality except in so far as they are concerned to avoid being sued for injuries in clinical trials. ”

There is a very informative and fascinating debate going on between Dr David Healy and Ben Goldacre regarding options, thoughts, strategies for better clinical trials access and transparency.
Dr. David Healy posted “fuckedhere and I posted a summary here.
Dr Ben Goldacre responded here and here. I republished his reply here.
Dr. David Healy then clarified here – see below – I only added few related links (in the original text response) with the purpose to bring more clarity and/or references to the readers.

Again let me invite you to read “fucked” post 22 comments – about clinical trial data access and pharmaceutical industry transparency.

image of David Healy
David Healy is professor of psychiatry and co-founder of data based medicine, operating through RxISK.org , working towards making medicines safer.

The first point to make is this post isn’t about AllTrials.
AllTrials is a footnote.

It’s about the dismay that many felt at EMA backsliding. It’s about how it was obvious that something like this was on the cards. Against this background uncritical endorsement of industry looked like a bad idea. There was a desperate need to stay awake. It looks like too many of us have been asleep.
Ben offers an outline of the AllTrials strategy here. It’s helpful to have this.
His accusation that these posts misrepresent campaigns, smear people, shout abuse, and hector from the sidelines looks like a description of posts by others elsewhere. With very few exceptions any comments to the various posts on this blog that in any way fail to support Ben or AllTrials have been deleted.
The post repeated an alternate analysis – that the main thing industry wants to hide are adverse event data.
In a post 18 months ago I outlined how to achieve this industry would in public deploy the issue of patient confidentiality as a main justification for hiding data. In this it seems to me they have been assisted by Iain Chalmers editorial with Patrick Vaillance and now by Ben.
The historical evolution of the confidentiality issue is that the first informed consent forms said nothing about not showing your data to anyone else. Unnoticed industry have slipped in a “we will of course show your data to no-one clause”.
At the EMA conference on data access in November 2012, I made two points. The second was that industry would assert the notion of their privacy rights – which they have done. The other was that no one signs to have their data sequestered. Afterwards, Iain Chalmers congratulated me on the point – I thought we were on the same page.
Whether adverse event data is key or not, Peter Gotzsche through the European Ombudsman and Tom Jefferson and Peter Doshi through Tamiflu and RIAT seem to me to have done more in practical terms to move the issues forward than anyone else. It leaves me wondering why there is an endless call to celebrate Ben and not Peter or Tom.
Some of us have been working the GSK system and can see what the pitfalls are. Even if not redacted, this is a system that will make it close to impossible to analyse CSRs properly. But if it’s not proclaimed by AllTrials first it seems like such insights are unwelcome.
In several posts before the latest debacle I outlined how in my opinion there was a real chance that magnificent though he has been and clearly morally right, Peter Gotzsche’s efforts may do more harm than good. Even without taking GSK’s preposterous data access system into account, pushing for data adds to the undue premium being put on RCTs Twenty years ago the moral case for access was as strong and the risks consequent on failing were much less in that we were less hypnotized by RCTs than we are now.
Far from responding shrilly, Peter Gotzsche recognized the risk and we have been collaborating ever more closely since. The issues are so complex we might all be making mistakes – the only people unwilling to concede this seem to be AllTrials.
The push for data access remains morally compelling but there are other things that can be done that might be more effective.
As the BBC program a week ago on Thalidomide, and previous posts here, make clear, industry fear a boycott more than anything else. It is the only thing they have ever responded to.
At the moment the focus is on a bunch of bureaucrats in EMA, who aren’t there with a brief to protect us other than by regulating the wording of advertisements.
The focus should be on doctors who treat patients. We could refuse to use drugs where there is no access to the data. It shouldn’t even take courage to do this. In my opinion, this is the call that’s needed now rather than a call to support more of what AllTrials have been doing. But who will lead such a call?
Along with colleagues I put forward a softer version of a boycott – an AbbVie – which encouraged doctors and patients to use drugs but to report on the adverse events which would in fact make these chemicals better medicines. It would be difficult for government or anyone else to gainsay this win-win option in the way they might come out against the lose-lose of a boycott.
There is a conflict of interest here. RxISK.org has a stake in this idea. It was set up before AllTrials to move ideas like this forward. I suspect those of us working on RxISK in the evenings and at weekends have been putting far more hours into the effort than the AllTrials team have.
At the end of the day, I may well be wrong on this, but I personally think AllTrials have been naïve. I don’t think industry are concerned about patient confidentiality except in so far as they are concerned to avoid being sued for injuries in clinical trials.
Recent decades have seen industry put Litigation Support Defences in place. As outlined a decade ago in Let Them Eat Prozac, putting a premium on clinical trials has been a key element in their litigation support strategy. Seen from this vantage point AllTrials offers Pharma a lot – all without the effort of having to conspire or fund a conspiracy.
Playing straight into industry’s hands is a hazard for all of us. Good intentions aren’t enough to save us. I’d rest more comfortably if the key players in AllTrials had a track record in bringing adverse events to light or even a record of supporting those trying to do so – if they’d really antagonized industry good and proper. It’s not that partnership isn’t nice but perhaps after playing hard to get first. ”

Find all our posts about the AllTrials campaign, Clinical trials, Dr Ben GoldacreDr. David HealyGlaxoSmithKlinePeter Gøtzsche and Sir Iain Chalmers.