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AllTrials
Founded2013
FounderBen Goldacre, Sense About Science
Location
Key people
Ben Goldacre
Websitehttp://alltrials.net


AllTrials (sometimes called All Trials or AllTrials.net) is a collaborative project which advocates that clinical research adopt principles of open research. The project summarizes itself as "All trials registered, all results reported": that is, all clinical trials should be listed in a clinical trials registry, and their results should always be shared as open data.

At the center of the campaign is a petition signed by over 85,000 individuals and 599 organisations (as of August 2015):

Thousands of clinical trials have not reported their results; some have not even been registered.

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.

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

We call on governments, regulators and research bodies to implement measures to achieve this.

— Fulltext of AllTrials Petition

Ben Goldacre, author of Bad Science and Bad Pharma, is a founder of the campaign and its most public spokesperson.

History

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The AllTrials campaign was launched by the British charity Sense About Science on in January 2013.[1] AllTrials was born from dissatisfied participants of clinical trials, who felt that their contributions to clinical research was lost because pharmaceutical companies neglected to publish results of said clinical trials.[2] The campaign came to life with a letter written by 53 clinical trials participants, which was directly addressed to the executive director of the European Medical Agency on January 18th 2013.[3] This letter clearly stated their dissatisfaction with the fact that the results of half of clinical trials do not get published or reported. The campaign subsequently quickly gained traction and reached a major turning point by gaining the support from one of the biggest pharmaceutical companies, GlaxoSmithKline, in 2013.[4] In the same year, the campaign recruited its supporters to assist in the redrafting of the European clinical trials law to erase legal loopholes and increase a legal obligation for the reporting of clinical trial data.[citation needed] They were joined in this endeavour by European MP Glenis Willmott.[5] The new Clinical Trials Regulation law was passed in April 2014.[5] In 2015, the World Health Organization published their position on the reporting of clinical trials, which aligns with the goals of the AllTrials campaign, thus increasing pressure on regulating bodies to require the publication of clinical trial results.[citation needed]

Mission

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The project is a reaction to under-reporting of research.[6][7][8][9]

A substantial proportion (estimates range from one-third to one-half) of medical research goes unpublished.[10] It has also been shown that negative findings are less likely to be published than positive ones, even in the absence of conflicts of interest.

Much medical research is done by the pharmaceutical industry, which have a conflict of interest reporting results which may hurt sales of their products.[11] There is a measurable bias in reporting; studies have shown that published drug studies funded by pharmaceutical companies are much more likely to support the use of the tested drug than studies with other funding. Industry-funded trials are also less likely to be published[12][13]

If the statistical methods used to analyse the trial are not chosen before the study it started, there is a danger that researchers will intentionally or unintentionally pick the method that gives the results they expect, or which gives the most significant results. This makes the analysis statistically invalid.

Pre-trial registration makes non-publication and changes in analysis methods obvious to medical reviewers. It also enables authors of meta-studies to track down and analyse missing data.

There are other sources of bias, such as the conditions sometimes attached to funding by funding agencies with a financial interest in the trial's outcome. Medical researchers may be asked to agree to allow the funding agency to censor results. Some funding agencies may also refuse to give the medical researcher access to the raw data, giving them only the finished analysis, or even a draft paper, and asking them to put their name to it. This is not acceptable academic practice, and some academic journals require that authors sign a statement that they have not entered into such agreements.[11][13]

Ben Goldacre, a physician and spokesperson for the campaign, would like to address the systematic flaws in clinical research which cause data to be lost after it is gathered.[14][15][16][17][18][19][20]

Coverage

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The campaign has been widely covered, and supported, in the academic press. The British Medical Journal and PLOS are founding members. Nature[21] and The Lancet[22] both published supportive articles in January 2014.

There has also been mainstream media coverage.[23]

Criticism

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There has been criticism from the Pharmaceutical Research and Manufacturers of America (PhRMA), with senior vice-president Matt Bennett saying that trial data disclosure measures which AllTrials has recommended to the European Medicines Agency "could risk patient privacy, lead to fewer clinical trials, and result in fewer new medicines to meet patient needs and improve health.".[24]

AllTrials have published a detailed statement[25] of exactly what they want to see published, which states "The AllTrials campaign is not calling for individual patient data to be made publicly available" [bolding original].

A 2012 editorial published by senior regulators from the European Medicines agency[26] largely agreed with AllTrials, saying "We consider it neither desirable nor realistic to maintain the status quo of limited availability of regulatory trials data". They were also of the opinion that adequate standards for protection of personal data could be written. However, they warned that third party reanalysis was neither a guarantee of quality nor of lack of conflict of interest, which, in the worst case, could lead to negative public health consequences.

"We do not dispute that financial conflicts of interests (CoIs) may render analyses and conclusions “vulnerable to distortion”. However, surrounding the ongoing debate over sponsor-independent analyses is an implicit assumption that “analysis by independent groups” is somehow free from CoIs. We beg to differ. Personal advancement in academia, confirmation of previously defended positions, or simply raising one's own visibility within the scientific community may be powerful motivators.... We submit that analyses by sponsor-independent scientists are not generated in a CoI-free zone and, more often than not, ego trumps money. Independent analyses may therefore also be “vulnerable to distortion”. We are concerned that unrestricted availability of full datasets may in some cases facilitate the publication of papers containing misleading results, which in turn lead to urgent calls for regulatory action. In a worst case, this would give rise to unfounded health scares with negative public health consequences

such as patients refusing vaccinations or discontinuing drug treatment'"

They suggested that reanalyses should therefore be subject to the same regulations as sponsor analyses, such as registering analysis plans. They argued against completely unrestricted access to data, but in favour of broader access.[26] AllTrials is not calling for completely unrestricted access to raw data,[25] so the scope of disagreements is limited to what restrictions should be in place.

Supporters

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The campaign is an initiative of the charity Sense About Science[1][27], Bad Science[28], BMJ, the James Lind Initiative and the Centre for Evidence-Based Medicine. In April 2013, The Cochrane Collaboration joined these organizations as a core contributor to the campaign.[29][30][31][32] In the same year, the European Consumer Organisation,[33]

The campaign is an initiative of Sense About Science,[34] Centre for Evidence Based Medicine, The Dartmouth Institute for Health Policy and Clinical Practice,[35] James Lind Alliance, Cochrane Collaboration,[31][32] BMJ Group, PLOS,[36] and Bad Science. The petition statement of AllTrials has been signed by organizations including Wellcome Trust,[37] British Library, Medical Research Council (UK), British Heart Foundation, Institute for Quality and Efficiency in Health Care, National Institute for Health and Care Excellence, BioMed Central,[38] National Physicians Alliance, Royal Society of Medicine, Health Research Authority, American Medical Student Association, GlaxoSmithKline,[4] and others.

In August 2013 there were 55,000 signatories supporting the campaign.[39] In August 2015 there were over 85,000 signatories supporting the campaign.[40]

85 investors with >€3.5 trillion (£2.45trn; $3.83trn) of investments have supported AllTrials (as of July 2015), with Peter van der Werf of RobecoSAM saying: "We deem this to be a financially material factor and encourage all companies to gain credibility regarding their approach to clinical trial transparency by signing up to the AllTrials principles.".[41]

Opponents

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The European Federation of Pharmaceutical Industries and Associations and Pharmaceutical Research and Manufacturers of America have expressed interest in lobbying against the campaign.[42] Campaign supporters criticized Hoffmann-La Roche's plans to be more open but not to the extent requested by AllTrials.[43][44]

See also

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References

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  1. ^ a b "AllTrials campaign launch". Sense About Science. Sense About Science. 9 January 2013. Retrieved 3 August 2015.
  2. ^ Butterworth, Trevor (31 July 2015). "The story of AllTrials". AllTrials. All Trials. Retrieved 3 August 2015.
  3. ^ "Letter to EMA from clinical trial participants" (PDF). AllTrials. AllTrials. 18 January 2013. Retrieved 3 August 2015.
  4. ^ a b GlaxoSmithKline (5 February 2013). "GSK announces support for AllTrials campaign for clinical data transparency". gsk.com. Retrieved 26 October 2013.
  5. ^ a b McConaghie, Andrew (3 April 2014). "Europe votes for clinical trial transparency law". http://www.pharmaphorum.com/. pharmaphorum media. Retrieved 12 October 2015. {{cite web}}: External link in |website= (help)
  6. ^ Chalmers, I.; Glasziou, P.; Godlee, F. (2013). "All trials must be registered and the results published". BMJ. 346: f105. doi:10.1136/bmj.f105. PMID 23303893.
  7. ^ Bell, Alice (8 February 2013). "All Trials: working with the public to reform science". theguardian.com. Retrieved 26 October 2013.
  8. ^ Glasziou, Paul (15 January 2013). "Register all trials, report all results – it's long overdue". The Conversation. Retrieved 26 October 2013.
  9. ^ Cressey, D. (2013). "Secrets of trial data revealed". Nature. 502 (7470): 154–155. doi:10.1038/502154a. PMID 24108030.
  10. ^ http://blogs.nature.com/news/2013/10/ethical-failure-leaves-one-quarter-of-all-clinical-trials-unpublished.html
  11. ^ a b http://www.nejm.org/doi/full/10.1056/NEJMed010093
  12. ^ Jones, C. W.; Handler, L.; Crowell, K. E.; Keil, L. G.; Weaver, M. A.; Platts-Mills, T. F. (2013). "Non-publication of large randomized clinical trials: cross sectional analysis". BMJ. 347 (oct28 9): f6104–f6104. doi:10.1136/bmj.f6104. ISSN 1756-1833.
  13. ^ a b http://www.washingtonpost.com/business/economy/as-drug-industrys-influence-over-research-grows-so-does-the-potential-for-bias/2012/11/24/bb64d596-1264-11e2-be82-c3411b7680a9_story.html
  14. ^ Fiore, Kristina (23 February 2013). "Is Evidence-Based Medicine Only an Illusion?". MedPage Today. Retrieved 26 October 2013.
  15. ^ Buch, Prateek (10 January 2013). "Opinion: AllTrials.net – a crucial campaign on data transparency that will save lives". Liberal Democrat Voice. Retrieved 26 October 2013.
  16. ^ Biome staff (20 May 2013). "Ben Goldacre on Clinical Trials". biomedcentral.com. Retrieved 26 October 2013.
  17. ^ Goldacre, Ben (1 February 2013). "Health Care's Trick Coin". The New York Times. New York: NYTC. ISSN 0362-4331. Retrieved 26 October 2013.
  18. ^ Doyle, Kathryn (14 March 2013). "Surgery clinical trial results selectively reported". Chicago Tribune. Retrieved 26 October 2013.
  19. ^ Olijnyk, Zena (22 Feb 2013). "Bad Pharma's bitter pill to swallow". m.bnn.ca. Business News Network. Retrieved 26 October 2013.
  20. ^ Stugess, Kylie (27 February 2013). "Bad Pharma – Interview with Ben Goldacre". Skeptical Inquirer. Committee for Skeptical Inquiry. Retrieved 26 October 2013.
  21. ^ http://www.nature.com/news/data-sharing-will-pay-dividends-1.14468
  22. ^ http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2813%2962228-X/fulltext
  23. ^ http://www.nytimes.com/2013/07/05/opinion/full-disclosure-needed-for-clinical-drug-data.html?smid=tw-share&_r=0
  24. ^ http://www.theguardian.com/business/2013/jul/21/big-pharma-secret-drugs-trials
  25. ^ a b http://www.alltrials.net/2013/all-trials-registered-and-results-reported/
  26. ^ a b Eichler HG, Abadie E, Breckenridge A, Leufkens H, Rasi G (2012). "Open clinical trial data for all? A view from regulators". PLoS Med. 9 (4): e1001202. doi:10.1371/journal.pmed.1001202. PMC 3323505. PMID 22505851.{{cite journal}}: CS1 maint: multiple names: authors list (link) CS1 maint: unflagged free DOI (link)
  27. ^ Mansell, Peter (10 January 2013). "AllTrials campaign raises the game on clinical-trial transparency". PharmaTimes Digital. PharmaTimes. Retrieved 3 August 2015.
  28. ^ Goldacre, Ben (16 January 2013). "AllTrials campaign launches, please sign and spread!". Bad Science. Bad Science. Retrieved 3 August 2015.
  29. ^ "The Cochrane Collaboration joins AllTrials campaign". Sense About Science. Sense About Science. 19 April 2013. Retrieved 3 August 2015.
  30. ^ "Cochrane signs up to AllTrials initiative to campaign for registration and reporting of all clinical trials". Cochrane Community. The Cochrane Collaboration. Retrieved 3 August 2015.
  31. ^ a b Cochrane Collaboration (2013). "Cochrane signs up to AllTrials initiative to campaign for registration and reporting of all clinical trials". cochrane.org. Retrieved 26 October 2013.
  32. ^ a b Brown, Tracy (30 April 2013). "Editorial : It's time for AllTrials registered and reported". thecochranelibrary.com. Retrieved 26 October 2013.
  33. ^ "BEUC joins AllTrials". AllTrials. AllTrials. 24 May 2013. Retrieved 12 August 2015.
  34. ^ Sense about Science (9 January 2013). "AllTrials campaign launch". senseaboutscience.org. Retrieved 26 October 2013.
  35. ^ The Dartmouth Institute for Health Policy and Clinical Practice (2013). "AllTrials campaign launched in US - Dartmouth's Geisel School of Medicine to lead the US campaign for all clinical trials to be registered and results reported". tdi.dartmouth.edu. Retrieved 26 October 2013. {{cite web}}: |author= has generic name (help)
  36. ^ Barbour, Virginia (18 January 2013). "Getting serious about registering and reporting trials". blogs.plos.org. Retrieved 26 October 2013.
  37. ^ Wellcome Trust (16 September 2013). "House of Commons - Science and Technology Committee: Written evidence submitted by the Wellcome Trust". publications.parliament.uk. Retrieved 26 October 2013.
  38. ^ BioMed Central (12 August 2013). "A Call to Action from AllTrials". blogs.biomedcentral.com. Retrieved 26 October 2013.
  39. ^ Stoye, Emma (7 August 2013). "AllTrials releases plan for clinical trial reporting". Chemistry World. Retrieved 26 October 2013.
  40. ^ http://www.alltrials.net/
  41. ^ http://dx.doi.org/10.1136/bmj.h4002
  42. ^ Sample, Ian (21 July 2013). "Big pharma mobilising patients in battle over drugs trials data". theguardian.com. Retrieved 26 October 2013.
  43. ^ Hoffmann-La Roche (26 February 2013). "Roche launches new process for accessing clinical trial data". roche.com. Retrieved 26 October 2013.
  44. ^ Walsh, Fergus (26 February 2013). "Drug firm Roche pledges greater access to trials data". bbc.co.uk. Retrieved 26 October 2013.
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Category:Clinical research Category:Human subject research Category:Open science Category:Open data Category:Research projects Category:Scientific misconduct Category:Medical ethics Category:Health campaigns Category:Petitions Category:Medical activism Category:Scientific skepticism

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