AllTrials

The project is a reaction to under-reporting of research.{{cite journal |doi=10.1136/bmj.f105 |pmid=23303893 |title=All trials must be registered and the results published |journal=BMJ |volume=346 |pages=f105 |year=2013 |last1=Chalmers |first1=I |last2=Glasziou |first2=P |last3=Godlee |first3=F |s2cid=40236020 |url=http://www.bmj.com/content/bmj/346/bmj.f105.full.pdf |doi-access=free }}{{cite web |url= https://www.theguardian.com/science/political-science/2013/feb/08/all-trials-reform-science |title=All Trials: working with the public to reform science |first=Alice |last=Bell |work=theguardian.com |date=8 February 2013 |access-date=26 October 2013}}{{cite web |url= http://theconversation.com/register-all-trials-report-all-results-its-long-overdue-11603 |title=Register all trials, report all results – it's long overdue |first=Paul |last=Glasziou |work=The Conversation |date=15 January 2013 |access-date=26 October 2013}}{{cite journal |doi=10.1038/502154a |pmid=24108030 |title=Secrets of trial data revealed |journal=Nature |volume=502 |issue=7470 |pages=154–5 |year=2013 |last1=Cressey |first1=Daniel |bibcode=2013Natur.502..154C |doi-access=free }}

A substantial proportion (estimates range from one-third to one-half) of medical research goes unpublished.{{cite journal |doi=10.1136/bmj.f6104 |pmid=24169943 |pmc=3812466 |title=Non-publication of large randomized clinical trials: Cross sectional analysis |journal=BMJ |volume=347 |pages=f6104 |year=2013 |last1=Jones |first1=C. W |last2=Handler |first2=L |last3=Crowell |first3=K. E |last4=Keil |first4=L. G |last5=Weaver |first5=M. A |last6=Platts-Mills |first6=T. F}}

• {{lay source |template=cite news |author=Daniel Cressey |date=October 29, 2013 |title='Ethical failure' leaves one-quarter of all clinical trials unpublished |url=http://blogs.nature.com/news/2013/10/ethical-failure-leaves-one-quarter-of-all-clinical-trials-unpublished.html |work=Nature newsblog}} It has also been shown that negative findings are less likely to be published than positive ones, even in the absence of conflicts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.{{cn|date=May 2023}}

Much medical research is done by the pharmaceutical industry, which have a conflict of interest reporting results which may hurt sales of their products.{{cite journal |doi=10.1056/NEJMed010093 |pmid=11556304 |title=Sponsorship, Authorship, and Accountability |journal=New England Journal of Medicine |volume=345 |issue=11 |pages=825–6; discussion 826–7 |year=2001 |last1=Davidoff |first1=F |last2=Deangelis |first2=C. D |last3=Drazen |first3=J. M |last4=Nicholls |first4=M. G |last5=Hoey |first5=J |last6=Højgaard |first6=L |last7=Horton |first7=R |last8=Kotzin |first8=S |last9=Nylenna |first9=M |last10=Overbeke |first10=A. J |last11=Sox |first11=H. C |last12=Van Der Weyden |first12=M. B |last13=Wilkes |first13=M. S |pmc=81460 }} 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.{{cite web|url=https://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|title=As drug industry's influence over research grows, so does the potential for bias|first=Peter|last=Whoriskey|date=24 November 2012|via=www.washingtonpost.com}}

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.

Not publishing trials which fail to find a clear effect exposes trial volunteers to pointless risk{{cite journal |doi=10.1001/jama.290.4.516 |pmid=12876095 |title=Registering Clinical Trials |journal=JAMA |volume=290 |issue=4 |pages=516–23 |year=2003 |last1=Dickersin |first1=Kay |last2=Rennie |first2=D }} and wastes research effort (as the same trial is repeated over and over). It also biases the medical literature, making it report effects where none exist (since, given enough trials, eventually one will find a difference by pure chance).{{cite journal |doi=10.1080/01621459.1959.10501497 |jstor=2282137 |title=Publication Decisions and their Possible Effects on Inferences Drawn from Tests of Significance—or Vice Versa |journal=Journal of the American Statistical Association |volume=54 |issue=285 |pages=30–4 |year=1959 |last1=Sterling |first1=Theodore D }}

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. Finally, it lets doctors and patients know when a trial is looking for volunteers.

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.

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.{{cite web |url= http://www.medpagetoday.com/PublicHealthPolicy/ClinicalTrials/37506 |title=Is Evidence-Based Medicine Only an Illusion? |first=Kristina |last=Fiore |work=MedPage Today |date=23 February 2013 |access-date=26 October 2013}}{{cite web |url= http://www.libdemvoice.org/opinion-alltrialsnet-a-crucial-campaign-on-data-transparency-that-will-save-lives-32575.html |title=Opinion: AllTrials.net – a crucial campaign on data transparency that will save lives |first=Prateek |last=Buch |work=Liberal Democrat Voice |date=10 January 2013 |access-date=26 October 2013}}{{cite web |url=http://www.biomedcentral.com/biome/international-clinical-trials-day-a-qa-with-ben-goldacre/ |title=Ben Goldacre on Clinical Trials |author=Biome staff |work=biomedcentral.com |date=20 May 2013 |access-date=26 October 2013 |archive-url=https://web.archive.org/web/20131029185524/http://www.biomedcentral.com/biome/international-clinical-trials-day-a-qa-with-ben-goldacre/ |archive-date=2013-10-29 |url-status=dead }}{{cite news |url= https://www.nytimes.com/2013/02/02/opinion/health-cares-trick-coin.html?_r=0 |title=Health Care's Trick Coin |first=Ben |last=Goldacre |author-link=Ben Goldacre |work=The New York Times |date=1 February 2013 |location=New York |issn=0362-4331 |access-date=26 October 2013}}{{cite web |url= https://www.chicagotribune.com/2013/03/14/surgery-clinical-trial-results-selectively-reported/ |title=Surgery clinical trial results selectively reported |first=Kathryn |last=Doyle |work=Chicago Tribune |date=14 March 2013 |access-date=26 October 2013}}{{cite web |url= http://m.bnn.ca/article?itemId=Bad-Pharmas-bitter-pill-to-swallow&feedId=322 |title=Bad Pharma's bitter pill to swallow |first=Zena |last=Olijnyk |work=m.bnn.ca |publisher=Business News Network |date=22 Feb 2013 |access-date=26 October 2013}}{{cite web |url= http://www.csicop.org/specialarticles/show/bad_pharma_interview_with_ben_goldacre |title=Bad Pharma – Interview with Ben Goldacre |first=Kylie |last=Stugess |work=Skeptical Inquirer |publisher=Committee for Skeptical Inquiry |date=27 February 2013 |access-date=26 October 2013}}

The campaign has been widely covered, and supported, in the academic press. The British Medical Journal and PLOS are founding members. Nature{{cite journal |doi=10.1038/505131a |pmid=24409508 |title=Data sharing will pay dividends |journal=Nature |volume=505 |issue=7482 |pages=131 |year=2014 |doi-access=free }} and The Lancet{{cite journal |doi=10.1016/S0140-6736(13)62228-X |pmid=24411647 |title=Reducing waste from incomplete or unusable reports of biomedical research |journal=The Lancet |volume=383 |issue=9913 |pages=267–76 |year=2014 |last1=Glasziou |first1=Paul |last2=Altman |first2=Douglas G |last3=Bossuyt |first3=Patrick |last4=Boutron |first4=Isabelle |last5=Clarke |first5=Mike |last6=Julious |first6=Steven |last7=Michie |first7=Susan |last8=Moher |first8=David |last9=Wager |first9=Elizabeth |s2cid=28924552 }} both published supportive articles in January 2014.

There has also been mainstream media coverage.{{cite news|url=https://www.nytimes.com/2013/07/05/opinion/full-disclosure-needed-for-clinical-drug-data.html|title=Opinion - Full Disclosure Needed for Clinical Drug Data|author=The Editorial Board|newspaper=The New York Times |date=4 July 2013}}

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.".{{cite web|url=https://www.theguardian.com/business/2013/jul/21/big-pharma-secret-drugs-trials|title=Big pharma mobilising patients in battle over drugs trials data|first=Ian|last=Sample|date=21 July 2013|website=the Guardian}}

AllTrials have published a detailed statement{{cite web|url=http://www.alltrials.net/2013/all-trials-registered-and-results-reported/|title=All trials registered and results reported}} 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 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.{{cn|date=May 2023}}

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 favor of broader access.{{cite journal |doi=10.1371/journal.pmed.1001202 |pmid=22505851 |pmc=3323505 |title=Open Clinical Trial Data for All? A View from Regulators |journal=PLOS Medicine |volume=9 |issue=4 |pages=e1001202 |year=2012 |last1=Eichler |first1=Hans-Georg |last2=Abadie |first2=Eric |last3=Breckenridge |first3=Alasdair |last4=Leufkens |first4=Hubert |last5=Rasi |first5=Guido |doi-access=free }} AllTrials is not calling for completely unrestricted access to raw data, so the scope of disagreements is limited to what restrictions should be in place.

{{Missing information|the substance of the disagreement|date=August 2015}}

The campaign is an initiative of Sense about Science,{{cite web |url=http://www.senseaboutscience.org/news.php/292/alltrials-campaign-launch |title=AllTrials campaign launch |author=Sense about Science |work=senseaboutscience.org |date=9 January 2013 |access-date=26 October 2013 |archive-url=https://web.archive.org/web/20131029192917/http://www.senseaboutscience.org/news.php/292/alltrials-campaign-launch |archive-date=2013-10-29 |url-status=dead |author-link=Sense about Science }} Centre for Evidence Based Medicine, The Dartmouth Institute for Health Policy and Clinical Practice,{{cite press release |url=http://tdi.dartmouth.edu/press/press-releases/alltrials-campaign-launched-in-us |title=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 |website=The Dartmouth Institute |year=2013 |access-date=26 October 2013}} James Lind Alliance, Cochrane Collaboration,{{cite web |url= http://www.cochrane.org/features/cochrane-signs-alltrials-initiative-campaign-registration-and-reporting-all-clinical-trials |title=Cochrane signs up to AllTrials initiative to campaign for registration and reporting of all clinical trials |author =Cochrane Collaboration |work=cochrane.org |year=2013 |access-date=26 October 2013|author-link=Cochrane Collaboration }}{{cite web |url=http://www.thecochranelibrary.com/details/editorial/4627901/Its-time-for-AllTrials-registered-and-reported.html |title=Editorial : It's time for AllTrials registered and reported |first=Tracy |last=Brown |work=thecochranelibrary.com |date=30 April 2013 |access-date=26 October 2013 |archive-url=https://web.archive.org/web/20131029195449/http://www.thecochranelibrary.com/details/editorial/4627901/Its-time-for-AllTrials-registered-and-reported.html |archive-date=29 October 2013 |url-status=dead }} BMJ Group, PLOS,{{cite web |url= http://blogs.plos.org/speakingofmedicine/2013/01/18/getting-serious-about-registering-and-reporting-trials-alltrials-net/ |title=Getting serious about registering and reporting trials |first=Virginia |last=Barbour |work=blogs.plos.org |date=18 January 2013 |access-date=26 October 2013}} and Bad Science. The petition statement of AllTrials has been signed by organizations including Wellcome Trust,{{cite web |url= https://publications.parliament.uk/pa/cm201314/cmselect/cmsctech/104/104we19.htm |title=House of Commons - Science and Technology Committee: Written evidence submitted by the Wellcome Trust |author =Wellcome Trust |work=publications.parliament.uk |date=16 September 2013 |access-date=26 October 2013|author-link=Wellcome Trust }} 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,{{cite web |url=http://blogs.biomedcentral.com/bmcblog/2013/08/12/a-call-to-action-from-alltrials/ |title=A Call to Action from AllTrials |author=BioMed Central |work=blogs.biomedcentral.com |date=12 August 2013 |access-date=26 October 2013 |archive-url=https://web.archive.org/web/20131029202524/http://blogs.biomedcentral.com/bmcblog/2013/08/12/a-call-to-action-from-alltrials/ |archive-date=2013-10-29 |url-status=dead |author-link=BioMed Central }} National Physicians Alliance, Royal Society of Medicine, Health Research Authority, American Medical Student Association, GlaxoSmithKline,{{cite web |url=http://www.gsk.com/media/press-releases/2013/GSK-announces-support-forAll-Trials-campaign-for-clinical-data-transparency.html |title=GSK announces support for AllTrials campaign for clinical data transparency |author=GlaxoSmithKline |work=gsk.com |date=5 February 2013 |access-date=26 October 2013 |archive-url=https://web.archive.org/web/20131029190856/http://www.gsk.com/media/press-releases/2013/GSK-announces-support-forAll-Trials-campaign-for-clinical-data-transparency.html |archive-date=2013-10-29 |url-status=dead |author-link=GlaxoSmithKline }} and others.

As of May 2017, The AllTrials petition has been signed by 90,282 people and 721 organisations.{{cite web|title = All Trials Registered. All Results Reported|url = http://www.alltrials.net/|website = AllTrials|access-date = 2015-11-17}} In October 2016, AllTrials published a road map detailing steps that various types of organisations can take to get more trials registered and more results reported.AllTrials campaign. 2017. Alltrials Roadmap http://www.alltrials.net/wp-content/uploads/2017/02/AllTrials-Roadmap.pdf

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.".{{cite journal |doi=10.1136/bmj.h4002 |pmid=26207007 |title=Investment managers back greater transparency of clinical trials |journal=BMJ |volume=351 |pages=h4002 |year=2015 |last1=Hawkes |first1=Nigel |s2cid=38566459 }} The Laura and John Arnold Foundation provided early and ongoing financial support.{{cite magazine|last1=Apple|first1=Sam|title=The Young Billionaire Behind the War on Bad Science|url=https://www.wired.com/2017/01/john-arnold-waging-war-on-bad-science/|magazine=Wired|date=January 22, 2017}}

The original policy of the Coalition for Epidemic Preparedness Innovations required that funded parties pre-register any trials in a clinical trials registry, publish results within a year of study completion (except with compelling reason and permission of CEPI), publish results in open-access articles, and have mechanisms for securely sharing underlying data and results, including negative results, in a way that preserves trial volunteer privacy. In May 2018 the CEPI proposed changing the policy to remove these provisions.{{cite web |title=MSF's response to CEPI's policy regarding equitable access |url=https://msfaccess.org/msfs-response-cepis-policy-regarding-equitable-access |website=Médecins Sans Frontières Access Campaign |date=25 September 2018 |language=en}} The policy was changed by the CEPI in December 2018.{{cite web |title=Open letter to CEPI Board Members: Revise CEPI's access policy |url=https://msfaccess.org/open-letter-cepi-board-members-revise-cepis-access-policy |website=Médecins Sans Frontières Access Campaign |date=5 March 2019 |language=en}}{{cite news | url=https://www.nytimes.com/2020/03/02/opinion/contributors/pharma-vaccines.html | title=Big Pharma May Pose an Obstacle to Vaccine Development | date=2 March 2020 | access-date=8 March 2020 | newspaper=The New York Times | author=Gerald Posner | quote=Drug companies on CEPI's scientific advisory panel, including Johnson & Johnson, Pfizer, and Japan's Takeda, pushed back. CEPI mostly capitulated in a December 2018 two-page declaration in which it jettisoned specifics but gave lip service to its founding mission of "equitable access to these vaccines for affected populations during outbreaks."| author-link=Gerald Posner }}

The European Federation of Pharmaceutical Industries and Associations and Pharmaceutical Research and Manufacturers of America have expressed interest in lobbying against the campaign.{{cite web |url= https://www.theguardian.com/business/2013/jul/21/big-pharma-secret-drugs-trials?CMP=twt_fd |title=Big pharma mobilising patients in battle over drugs trials data |first=Ian |last=Sample |work=theguardian.com |date=21 July 2013 |access-date=26 October 2013}} Campaign supporters criticized Hoffmann-La Roche's plans to be more open but not to the extent requested by AllTrials.{{cite web |url= http://www.roche.com/media/media_releases/med-cor-2013-02-26.htm |title= Roche launches new process for accessing clinical trial data |author= Hoffmann-La Roche |work= roche.com |date= 26 February 2013 |access-date= 26 October 2013 |archive-url= https://web.archive.org/web/20131029191549/http://www.roche.com/media/media_releases/med-cor-2013-02-26.htm |archive-date= 2013-10-29 |url-status= dead }}{{cite web |url= https://www.bbc.co.uk/news/health-21595895 |title=Drug firm Roche pledges greater access to trials data |first=Fergus |last=Walsh |author-link=Fergus Walsh |work=bbc.co.uk |date=26 February 2013 |access-date=26 October 2013}}

• Clinical data repository
• Conflicts of interest in academic publishing
• Monitoring in clinical trials
• Metascience
• Privacy for research participants
• Evidence-based medicine
• Clinical trials publication
• Censoring (clinical trials)

{{Reflist}}

• {{official website|http://www.alltrials.net/}}
• [http://www.tedmed.com/talks/show?id=7299 Where's the rest of the data iceberg?], a video presentation by Ben Goldacre at TEDMED

{{conflict of interest}}

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