AllTrials

AllTrials (sometimes called All Trials or AllTrials.net) is a project advocating that clinical research adopt the 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 organisation 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.

AllTrials is an international initiative of Bad Science, BMJ, Centre for Evidence-based Medicine, Cochrane Collaboration, James Lind Initiative, PLOS and Sense About Science and is being led in the US by Sense About Science USA, Dartmouth’s Geisel School of Medicine and the Dartmouth Institute for Health Policy & Clinical Practice.[1]

Issues addressed

The project is a reaction to under-reporting of research.[2][3][4][5]

A substantial proportion (estimates range from one-third to one-half) of medical research goes unpublished.[6] It has also been shown that negative findings are less likely to be published than positive ones, even in the absence of conflicts of interest.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.[7] There is a measurable funding 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[8][9]

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.[7][9]

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.[10][11][12][13][14][15][16]

Coverage

The campaign has been widely covered, and supported, in the academic press. The British Medical Journal and PLOS are founding members. Nature[17] and The Lancet[18] both published supportive articles in January 2014.

There has also been mainstream media coverage.[19]

Criticism

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.".[20]

AllTrials have published a detailed statement[21] 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".

A 2012 editorial published by senior regulators from the European Medicines agency[22] 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.[22] AllTrials is not calling for completely unrestricted access to raw data,[21] so the scope of disagreements is limited to what restrictions should be in place.

Supporters

The campaign is an initiative of Sense About Science,[23] Centre for Evidence Based Medicine, The Dartmouth Institute for Health Policy and Clinical Practice,[24] James Lind Alliance, Cochrane Collaboration,[25][26] BMJ Group, PLOS,[27] and Bad Science. The petition statement of AllTrials has been signed by organizations including Wellcome Trust,[28] 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,[29] National Physicians Alliance, Royal Society of Medicine, Health Research Authority, American Medical Student Association, GlaxoSmithKline,[30] and others.

In August 2013 there were 55,000 signatories supporting the campaign.[31] In August 2015 there were over 85,000 signatories supporting the campaign.[32]

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.".[33]

Opponents

The European Federation of Pharmaceutical Industries and Associations and Pharmaceutical Research and Manufacturers of America have expressed interest in lobbying against the campaign.[34] Campaign supporters criticized Hoffmann-La Roche's plans to be more open but not to the extent requested by AllTrials.[35][36]

See also

References

  1. ↑ "All Trials Registered. All Results Reported". AllTrials. Retrieved 2015-11-17.
  2. ↑ 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.
  3. ↑ Bell, Alice (8 February 2013). "All Trials: working with the public to reform science". theguardian.com. Retrieved 26 October 2013.
  4. ↑ Glasziou, Paul (15 January 2013). "Register all trials, report all results – it's long overdue". The Conversation. Retrieved 26 October 2013.
  5. ↑ Cressey, D. (2013). "Secrets of trial data revealed". Nature. 502 (7470): 154–155. doi:10.1038/502154a. PMID 24108030.
  6. ↑ http://blogs.nature.com/news/2013/10/ethical-failure-leaves-one-quarter-of-all-clinical-trials-unpublished.html
  7. 1 2 http://www.nejm.org/doi/full/10.1056/NEJMed010093
  8. ↑ 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.
  9. 1 2 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
  10. ↑ Fiore, Kristina (23 February 2013). "Is Evidence-Based Medicine Only an Illusion?". MedPage Today. Retrieved 26 October 2013.
  11. ↑ 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.
  12. ↑ Biome staff (20 May 2013). "Ben Goldacre on Clinical Trials". biomedcentral.com. Retrieved 26 October 2013.
  13. ↑ Goldacre, Ben (1 February 2013). "Health Care's Trick Coin". The New York Times. New York: NYTC. ISSN 0362-4331. Retrieved 26 October 2013.
  14. ↑ Doyle, Kathryn (14 March 2013). "Surgery clinical trial results selectively reported". Chicago Tribune. Retrieved 26 October 2013.
  15. ↑ Olijnyk, Zena (22 Feb 2013). "Bad Pharma's bitter pill to swallow". m.bnn.ca. Business News Network. Retrieved 26 October 2013.
  16. ↑ Stugess, Kylie (27 February 2013). "Bad Pharma – Interview with Ben Goldacre". Skeptical Inquirer. Committee for Skeptical Inquiry. Retrieved 26 October 2013.
  17. ↑ http://www.nature.com/news/data-sharing-will-pay-dividends-1.14468
  18. ↑ http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2813%2962228-X/fulltext
  19. ↑ http://www.nytimes.com/2013/07/05/opinion/full-disclosure-needed-for-clinical-drug-data.html?smid=tw-share&_r=0
  20. ↑ http://www.theguardian.com/business/2013/jul/21/big-pharma-secret-drugs-trials
  21. 1 2 http://www.alltrials.net/2013/all-trials-registered-and-results-reported/
  22. 1 2 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 3323505Freely accessible. PMID 22505851.
  23. ↑ Sense about Science (9 January 2013). "AllTrials campaign launch". senseaboutscience.org. Retrieved 26 October 2013.
  24. ↑ 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.
  25. ↑ 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.
  26. ↑ Brown, Tracy (30 April 2013). "Editorial : It's time for AllTrials registered and reported". thecochranelibrary.com. Retrieved 26 October 2013.
  27. ↑ Barbour, Virginia (18 January 2013). "Getting serious about registering and reporting trials". blogs.plos.org. Retrieved 26 October 2013.
  28. ↑ 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.
  29. ↑ BioMed Central (12 August 2013). "A Call to Action from AllTrials". blogs.biomedcentral.com. Retrieved 26 October 2013.
  30. ↑ GlaxoSmithKline (5 February 2013). "GSK announces support for AllTrials campaign for clinical data transparency". gsk.com. Retrieved 26 October 2013.
  31. ↑ Stoye, Emma (7 August 2013). "AllTrials releases plan for clinical trial reporting". Chemistry World. Retrieved 26 October 2013.
  32. ↑ http://www.alltrials.net/
  33. ↑ "Investment managers back greater transparency of clinical trials:". BMJ: h4002. doi:10.1136/bmj.h4002.
  34. ↑ Sample, Ian (21 July 2013). "Big pharma mobilising patients in battle over drugs trials data". theguardian.com. Retrieved 26 October 2013.
  35. ↑ Hoffmann-La Roche (26 February 2013). "Roche launches new process for accessing clinical trial data". roche.com. Retrieved 26 October 2013.
  36. ↑ 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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