The document discusses the persistent issues in clinical trial transparency, including publication bias, information dissemination, and discrepancies in trial reporting. It introduces Opentrials, a platform aimed at aggregating and improving access to trial data through crowd-sourcing and structured data collection. The document includes an overview of technical aspects, data sources, user examples, and invites contributions from various stakeholders in the research community.

1. Jessica Fleminger and Ben Meghreblian

2. 1. introduction
2. we (still) have a problem
3. OpenTrials overview
4. techy stuff
5. data sources
6. user examples
7. demo
8. Q&A
opentrials@okfn.org

3. opentrials@okfn.org

4. we (still) have a
problem
opentrials@okfn.orgaudiinsperation (CC BY)

5. Anderson et al. N Engl J Med. 2015 Mar 12;372(11):1031-9. doi: 10.1056/NEJMsa1409364.
Prayle AP et al. BMJ. 2012 Jan 3;344:d7373. doi: 10.1136/bmj.d7373.
we have a publication bias problem
opentrials@okfn.org

6. we have an information dissemination problem
vs.
clinical study reports
patient information sheets
consent forms
ethics committee documents
individual patient data
methods
opentrials@okfn.org
Jefferson T et al. BMJ. 2014 Apr 9;348:g2545. doi: 10.1136/bmj.g2545.
globalismpictures (CC BY)

7. we have a discrepancy problem
opentrials@okfn.org
Turner EH et al. N Engl J Med 2008; 358:252-260 doi: 10.1056/NEJMsa065779.
myrfa (CC0)

8. we have a publication bias problem
we have an information dissemination problem
we have a discrepancy problem
opentrials@okfn.org

9. we have an information
architecture problem
opentrials@okfn.orgAchriss713 (CC BY-SA)

10. Chalmers I, Altman DG. Lancet. 1999;353:490–3
doi: 10.1016/S0140-6736(98)07618-1.
threaded
publications
opentrials@okfn.orgTBIT (CC0)

11. opentrials@okfn.org
trial registers
academic
journals
regulatory
documents
structured data
on methods
and results
trial paperwork

12. !
WARNING
PHASE 1
release early
release often
opentrials@okfn.org

13. opentrials@okfn.org
!
WARNING
PHASE 1

14. audit publication bias
opentrials@okfn.orgmyrfa (CC0)

15. host/link important
trial documents
opentrials@okfn.orgPexels (CC0)

16. track sponsors and
organisations opentrials@okfn.org

17. search functionality
opentrials@okfn.org

18. investigate
discrepancies
opentrials@okfn.orgDeedster (CC0)

19. increase machine
readability
opentrials@okfn.orglmonk72 (CC0)

20. change sharing norms
opentrials@okfn.org422737 (CC0)

21. 1. introduction
2. we (still) have a problem
3. OpenTrials overview
4. techy stuff
5. data sources
6. user examples
7. demo
8. Q&A
opentrials@okfn.org

22. opentrials@okfn.org
OpenTrials architecture

23. scraping
crowdsourcing
data donations
attribution
and
licensing
opentrials@okfn.org

24. HTML
<div id="trial-info-2"
class="floater-50"><div
class="info-title">ClinicalTrials.gov
Identifier:</div><div
class="identifier">NCT01013220</div
><div class="info-date">First
received: November 12, 2009</div>
<div class="info-date">Last updated:
December 15, 2014</div><div
class="info-date">Last verified:
December 2014 </div><div
class="info-date"> <a
href="/ct2/archive/NCT01013220"
title="Historical versions of study
NCT01013220 on ClinicalTrials.gov
Archive Site - opens in new window"
onclick="openNewWindow('/ct2/archi
ve/NCT01013220'); return
false;">History of
Changes</a></div></div>
DatabaseXML
<primary_outcome>
<measure>employer purchase of
depression management
product</measure>
<time_frame>two years after
intervention</time_frame>
<safety_issue>No</safety_issue>
</primary_outcome>
<secondary_outcome>
<measure>
fidelity of depression
management model purchased
to evidence-based models
</measure>
<time_frame>two years after
intervention</time_frame>
<safety_issue>No</safety_issue>
</secondary_outcome>
<number_of_arms>2</number_of_ar
ms>
API
"id":
"a5d82296-8cb8-11e6-988b-0242ac1
2000c",
"source_id": "nct",
"identifiers": {
"nct": "NCT02920840"
},
"public_title": "Brain-oscillation
Synchronised Stimulation of the
Prefrontal Cortex",
"target_sample_size": 18,
"gender": "both",
"has_published_results": false,
"status": "ongoing",
"recruitment_status": "recruiting",
"registration_date":
"2016-09-26T00:00:00.000Z"
http://api.opentrials.net/v1/search?q=
depression&page=1&per_page=20
harder easier
structured data
scraping
opentrials@okfn.org

25. opentrials@okfn.org
data
donations

26. crowdsourcing
opentrials@okfn.org
User uploads
document
Document
approval
process
Document
live on
trial page

27. opentrials@okfn.org
attribution and licensing
bit.ly/illegalbullfrogs
Fir0002 (CC BY-SA)

28. 1. introduction
2. we (still) have a problem
3. OpenTrials overview
4. techy stuff
5. data sources
6. user examples
7. demo
8. Q&A
opentrials@okfn.org

29. 337,911 deduplicated trials
opentrials@okfn.org
imported: trial registers

30. ~510,000 publications
(~24,000 linked with trials)
errors found in some registry IDs
⇨ feedback via PubMed Commons
imported: publications
opentrials@okfn.org

31. imported: risk of bias scores
opentrials@okfn.org

32. ~22,000 research summaries
provides ‘lay summary’ explanation of
the trial for a non-medical audience
created for ethics committee
FOIA request ⇨ HRA for Patient Information Sheets
imported: research summaries
opentrials@okfn.org

33. 46,332 documents imported to Document Cloud and OCRed
16,329 FDA applications
live prototype: FDA Drug Approval Packages
opentrials@okfn.org
PDF
SimpleIcon (CC BY)

34. ongoing: clinical study reports
opentrials@okfn.org

35. ongoing: more...
opentrials@okfn.org
even asking has
been interesting...

36. 1. introduction
2. we have a problem
3. OpenTrials overview
4. techy stuff
5. data sources
6. user examples
7. demo
8. Q&A
opentrials@okfn.org

37. 1. researcher
2. doctor
3. patient
4. data journalist
5. developer
6. policy maker
7. regulator
opentrials@okfn.orgRhoda Baer (CC0)

38. 1. researcher
2. doctor
3. patient
4. data journalist
5. developer
6. policy maker
7. regulator
opentrials@okfn.orgIlmicrofono Oggiono (CC BY)

39. 1. researcher
2. doctor
3. patient
4. data journalist
5. developer
6. policy maker
7. regulator
opentrials@okfn.orgMichael Coghlan (CC BY-SA)

40. 1. researcher
2. doctor
3. patient
4. data journalist
5. developer
6. policy maker
7. regulator
opentrials@okfn.orgThe Data Journalism Handbook (CC BY-SA)

41. 1. researcher
2. doctor
3. patient
4. data journalist
5. developer
6. policy maker
7. regulator
opentrials@okfn.orggeralt (CC0)

42. 1. researcher
2. doctor
3. patient
4. data journalist
5. developer
6. policy maker
7. regulator
opentrials@okfn.orgolibac (CC BY)

43. 1. researcher
2. doctor
3. patient
4. data journalist
5. developer
6. policy maker
7. regulator
opentrials@okfn.org

44. 1. introduction
2. we have a problem
3. OpenTrials overview
4. techy stuff
5. data sources
6. user examples
7. demo
8. Q&A
opentrials@okfn.org

45. beta version!
explorer.opentrials.net
opentrials@okfn.org

46. please
contribute!
opentrials@okfn.org

47. thank you!
any questions?
opentrials@okfn.org / opentrials.net / @opentrials
Team OpenTrials: Ben Goldacre, Emma Beer, Stephen Abbott
Pugh, Paul Walsh, Vitor Baptista, Evgeny Karev, Victor Nițu,
Georgiana Bere, Sierra Williams, Lieke Ploeger, Sam Smith,
Ben Meghreblian, Sarah McNeill, Jessica Fleminger