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Y. Gray", "links": { "alternate": { "href": "https://www.zotero.org/jwyg", "type": "text/html" } } }, "creatorSummary": "Goldacre and Heneghan", "parsedDate": "2014-01-15", "numChildren": 2 }, "data": { "key": "D8ZZ5XCJ", "version": 33, "itemType": "journalArticle", "title": "Improving, and auditing, access to clinical trial results", "creators": [ { "creatorType": "author", "firstName": "Ben", "lastName": "Goldacre" }, { "creatorType": "author", "firstName": "Carl", "lastName": "Heneghan" } ], "abstractNote": "All trials should be registered, with their full methods and results reported, and routine audit on the extent of information withheld\n\nThe House of Commons Public Accounts Committee delivered a remarkable report on 3 January. Its initial remit was the United Kingdom’s £424m (€510m; $697m) stockpile of oseltamivir (Tamiflu), but the committee soon broadened out—with evident surprise—into the ongoing problem of clinical trial results being routinely and legally withheld from doctors, researchers, and patients.\n\nThis situation has persisted for too long. The first quantitative evidence on publication bias was published in 1986.1 Iain Chalmers described in 2006 how progress in the 1990s soon deteriorated into broken promises.2 Recent years have seen extensive denial. The Association of the British Pharmaceutical Industry (ABPI) has claimed that these problems are historic, and that results are now posted on clinicaltrials.gov. The recently defunct Ethical Standards in Health and Life Sciences Group,3 which most UK medical and academic professional bodies signed up to, falsely claimed that a “robust regulatory framework” ensures access to trial results.4 US legislation requiring all results to be posted on clinicaltrials.gov within 12 months of completion has been widely ignored,5 with no enforcement. 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Y. Gray", "links": { "alternate": { "href": "https://www.zotero.org/jwyg", "type": "text/html" } } }, "creatorSummary": "Goldacre", "parsedDate": "2013-07-09", "numChildren": 3 }, "data": { "key": "IMUIC338", "version": 33, "itemType": "journalArticle", "title": "Are clinical trial data shared sufficiently today? No", "creators": [ { "creatorType": "author", "firstName": "Ben", "lastName": "Goldacre" } ], "abstractNote": "The AllTrials campaign asks for all trials to be registered and their results published. Ben Goldacre says we need the evidence to make informed decisions about medicines. John Castellani (doi:10.1136/bmj.f1881) says mandatory disclosure could affect patient privacy, stifle discovery, and allow competitors or unscrupulous actors to use the information\n\nWhen discussing transparency it is important to be clear on what is being requested, as obfuscation is sometimes used to avoid discussing simple fixes. At stake are four levels of information about trials: (1) knowledge that a trial has been conducted, from a clinical trials register; (2) a brief summary of a trial’s results, in an academic journal article or regulatory summary; (3) longer details about the trial’s methods and results, from a clinical study report where available; (4) individual patient data. The AllTrials campaign calls only for the first three to be published.\n\nThe status quo is plainly unsatisfactory. The most current review—with no cherry picking permitted—estimates that around half of all trials for the treatments being used today have gone unpublished; and that trials with positive results are twice as likely to be disseminated.1 This is a problem for both industry and academic trials.\n\nAlthough some in industry claim that these problems are in the past, in reality all supposed fixes have failed. In 2005, journal editors passed regulations stating that they would publish only registered trials: the evidence now shows these regulations have been widely ignored.2 In 2007, US legislation was passed requiring all trials since 2008 to post results on clinicaltrials.gov within a year of completion: the best published evidence shows this law has been ignored by 60-90% of trials.3 If industry representatives believe these problems have been fixed, they should present published evidence to support their case, with methods and results that …", "publicationTitle": "BMJ", "publisher": "", "place": "", "date": "2013/07/09", "volume": "347", "issue": "", "section": "", "partNumber": "", "partTitle": "", "pages": "f1880", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "10.1136/bmj.f1880", "citationKey": "", "url": "http://www.bmj.com/content/347/bmj.f1880", "accessDate": "2015-04-08T14:23:46Z", "PMID": "23838460", "PMCID": "", "ISSN": "1756-1833", "archive": "", "archiveLocation": "", "shortTitle": "Are clinical trial data shared sufficiently today?", "language": "en", "libraryCatalog": "www.bmj.com", "callNumber": "", "rights": "© BMJ Publishing Group Ltd 2013", "extra": "", "tags": [], "collections": [], "relations": {}, "dateAdded": "2015-04-08T14:23:46Z", "dateModified": "2015-04-08T14:23:46Z" } }, { "key": "88WI6DEX", "version": 30, "library": { "type": "group", "id": 342474, "name": "Open Trials", "links": { "alternate": { "href": "https://www.zotero.org/groups/open_trials", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/342474/items/88WI6DEX", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/open_trials/items/88WI6DEX", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/342474/items/IMUIC338", "type": "application/json" } }, "meta": { "createdByUser": { "id": 30496, "username": "jwyg", "name": "Jonathan W. 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Y. 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Y. Gray", "links": { "alternate": { "href": "https://www.zotero.org/jwyg", "type": "text/html" } } }, "creatorSummary": "Prayle et al.", "parsedDate": "2012-01-03", "numChildren": 3 }, "data": { "key": "Q949VVK5", "version": 33, "itemType": "journalArticle", "title": "Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study", "creators": [ { "creatorType": "author", "firstName": "Andrew P.", "lastName": "Prayle" }, { "creatorType": "author", "firstName": "Matthew N.", "lastName": "Hurley" }, { "creatorType": "author", "firstName": "Alan R.", "lastName": "Smyth" } ], "abstractNote": "Objective To examine compliance with mandatory reporting of summary clinical trial results (within one year of completion of trial) on ClinicalTrials.gov for studies that fall under the recent Food and Drug Administration Amendments Act (FDAAA) legislation.\nDesign Registry based study of clinical trial summaries.\nData sources ClinicalTrials.gov, searched on 19 January 2011, with cross referencing with Drugs@FDA to determine for which trials mandatory reporting was required within one year.\nSelection criteria Studies registered on ClinicalTrials.gov with US sites which completed between 1 January and 31 December 2009.\nMain outcome measure Proportion of trials for which results had been reported.\nResults The ClinicalTrials.gov registry contained 83 579 entries for interventional trials, of which 5642 were completed within the timescale of interest. We identified trials as falling within the mandatory reporting rules if they were covered by the FDAAA (trials of a drug, device, or biological agent, which have at least one US site, and are of phase II or later) and if they investigated a drug that already had approval from the Food and Drug Administration. Of these, 163/738 (22%) had reported results within one year of completion of the trial compared with 76/727 (10%) trials that were not subject to mandatory reporting (95% confidence interval for the difference in proportions 7.8% to 15.5%; χ2 test, P=2.6×10−9). Later phase trials were more likely to report results (P=4.4×10−11), as were industry funded trials (P=2.2×10−16).\nConclusion Most trials subject to mandatory reporting did not report results within a year of completion.", "publicationTitle": "BMJ", "publisher": "", "place": "", "date": "2012/01/03", "volume": "344", "issue": "", "section": "", "partNumber": "", "partTitle": "", "pages": "d7373", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "10.1136/bmj.d7373", "citationKey": "", "url": "http://www.bmj.com/content/344/bmj.d7373", "accessDate": "2015-04-08T14:21:54Z", "PMID": "22214756", "PMCID": "", "ISSN": "0959-8138, 1468-5833", "archive": "", "archiveLocation": "", "shortTitle": "Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov", "language": "en", "libraryCatalog": "www.bmj.com", "callNumber": "", "rights": "© Prayle et al 2011. 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Y. Gray", "links": { "alternate": { "href": "https://www.zotero.org/jwyg", "type": "text/html" } } }, "creatorSummary": "Godlee", "parsedDate": "2012-10-29", "numChildren": 3 }, "data": { "key": "AE3NJ2W5", "version": 33, "itemType": "journalArticle", "title": "Clinical trial data for all drugs in current use", "creators": [ { "creatorType": "author", "firstName": "Fiona", "lastName": "Godlee" } ], "abstractNote": "Must be made available for independent scrutiny\n\nThe drug industry does many good things. It produces medicines that can improve health and save lives. It creates jobs and stimulates economic growth. Sadly it does bad things too. Persistently and systematically over decades it has withheld and misreported data from clinical trials.1 As a result, a whole range of widely used drugs across all fields of medicine have been represented as safer and more effective than they are, endangering people’s lives and wasting public money. Such wilful distortion is scientific misconduct.2 It is not something we can forgive because of the good things drug companies do. As Ben Goldacre says in the introduction to his new book Bad Pharma , “Drug companies around the world have produced some of the most amazing innovations of the past fifty years, saving lives on an epic scale. But that does not allow them to hide data, mislead doctors, and harm patients.”3\n\nHats off then to GlaxoSmithKline, which announced last month that it would allow access to anonymised patient level data from its clinical trials.4 An independent panel will assess all requests, and the company’s chief executive officer, Andrew Witty, says access will be granted on the basis of …", "publicationTitle": "BMJ", "publisher": "", "place": "", "date": "2012/10/29", "volume": "345", "issue": "", "section": "", "partNumber": "", "partTitle": "", "pages": "e7304", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "10.1136/bmj.e7304", "citationKey": "", "url": "http://www.bmj.com/content/345/bmj.e7304", "accessDate": "2015-04-08T14:02:12Z", "PMID": "23109483", "PMCID": "", "ISSN": "1756-1833", "archive": "", "archiveLocation": "", "shortTitle": "", "language": "en", "libraryCatalog": "www.bmj.com", "callNumber": "", "rights": "© BMJ Publishing Group Ltd 2012", "extra": "", "tags": [], "collections": [], "relations": {}, "dateAdded": "2015-04-08T14:02:12Z", "dateModified": "2015-04-08T14:02:12Z" } }, { "key": "RECUB7UC", "version": 27, "library": { "type": "group", "id": 342474, "name": "Open Trials", "links": { "alternate": { "href": "https://www.zotero.org/groups/open_trials", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/342474/items/RECUB7UC", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/open_trials/items/RECUB7UC", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/342474/items/AE3NJ2W5", "type": "application/json" } }, "meta": { "createdByUser": { "id": 30496, "username": "jwyg", "name": "Jonathan W. 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Y. Gray", "links": { "alternate": { "href": "https://www.zotero.org/jwyg", "type": "text/html" } } }, "creatorSummary": "Djulbegovic et al.", "parsedDate": "2000", "numChildren": 0 }, "data": { "key": "C5W6R8IT", "version": 26, "itemType": "journalArticle", "title": "The uncertainty principle and industry-sponsored research", "creators": [ { "creatorType": "author", "firstName": "Benjamin", "lastName": "Djulbegovic" }, { "creatorType": "author", "firstName": "Mensura", "lastName": "Lacevic" }, { "creatorType": "author", "firstName": "Alan", "lastName": "Cantor" }, { "creatorType": "author", "firstName": "Karen K", "lastName": "Fields" }, { "creatorType": "author", "firstName": "Charles L", "lastName": "Bennett" }, { "creatorType": "author", "firstName": "Jared R", "lastName": "Adams" }, { "creatorType": "author", "firstName": "Nicole M", "lastName": "Kuderer" }, { "creatorType": "author", "firstName": "Gary H", "lastName": "Lyman" } ], "abstractNote": "", "publicationTitle": "The Lancet", "publisher": "", "place": "", "date": "08/2000", "volume": "356", "issue": "9230", "section": "", "partNumber": "", "partTitle": "", "pages": "635-638", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "10.1016/S0140-6736(00)02605-2", "citationKey": "", "url": "http://linkinghub.elsevier.com/retrieve/pii/S0140673600026052", "accessDate": "2015-04-08T13:56:13Z", "PMID": "", "PMCID": "", "ISSN": "01406736", "archive": "", "archiveLocation": "", "shortTitle": "", "language": "en", "libraryCatalog": "CrossRef", "callNumber": "", "rights": "", "extra": "", "tags": [], "collections": [], "relations": {}, "dateAdded": "2015-04-08T13:56:13Z", "dateModified": "2015-04-08T13:56:13Z" } }, { "key": "VQKSFXAE", "version": 25, "library": { "type": "group", "id": 342474, "name": "Open Trials", "links": { "alternate": { "href": "https://www.zotero.org/groups/open_trials", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/342474/items/VQKSFXAE", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/open_trials/items/VQKSFXAE", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/342474/items/NS7KZPGV", "type": "application/json" } }, "meta": { "createdByUser": { "id": 30496, "username": "jwyg", "name": "Jonathan W. 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Y. Gray", "links": { "alternate": { "href": "https://www.zotero.org/jwyg", "type": "text/html" } } }, "numChildren": 0 }, "data": { "key": "MXHS7EMF", "version": 25, "parentItem": "NS7KZPGV", "itemType": "attachment", "linkMode": "imported_url", "title": "Full Text PDF", "accessDate": "2015-04-08T13:54:31Z", "url": "http://www.bmj.com/content/326/7400/1167.full.pdf", "note": "", "contentType": "application/pdf", "charset": "", "filename": "Lexchin et al. - 2003 - Pharmaceutical industry sponsorship and research o.pdf", "md5": null, "mtime": null, "tags": [], "relations": {}, "dateAdded": "2015-04-08T13:54:31Z", "dateModified": "2015-04-08T13:54:35Z" } }, { "key": "NS7KZPGV", "version": 33, "library": { "type": "group", "id": 342474, "name": "Open Trials", "links": { "alternate": { "href": "https://www.zotero.org/groups/open_trials", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/342474/items/NS7KZPGV", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/open_trials/items/NS7KZPGV", "type": "text/html" } }, "meta": { "createdByUser": { "id": 30496, "username": "jwyg", "name": "Jonathan W. Y. Gray", "links": { "alternate": { "href": "https://www.zotero.org/jwyg", "type": "text/html" } } }, "creatorSummary": "Lexchin et al.", "parsedDate": "2003-05-29", "numChildren": 3 }, "data": { "key": "NS7KZPGV", "version": 33, "itemType": "journalArticle", "title": "Pharmaceutical industry sponsorship and research outcome and quality: systematic review", "creators": [ { "creatorType": "author", "firstName": "Joel", "lastName": "Lexchin" }, { "creatorType": "author", "firstName": "Lisa A.", "lastName": "Bero" }, { "creatorType": "author", "firstName": "Benjamin", "lastName": "Djulbegovic" }, { "creatorType": "author", "firstName": "Otavio", "lastName": "Clark" } ], "abstractNote": "Objective To investigate whether funding of drug studies by the pharmaceutical industry is associated with outcomes that are favourable to the funder and whether the methods of trials funded by pharmaceutical companies differ from the methods in trials with other sources of support.\nMethods Medline (January 1966 to December 2002) and Embase (January 1980 to December 2002) searches were supplemented with material identified in the references and in the authors' personal files. Data were independently abstracted by three of the authors and disagreements were resolved by consensus.\nResults 30 studies were included. Research funded by drug companies was less likely to be published than research funded by other sources. Studies sponsored by pharmaceutical companies were more likely to have outcomes favouring the sponsor than were studies with other sponsors (odds ratio 4.05; 95% confidence interval 2.98 to 5.51; 18 comparisons). None of the 13 studies that analysed methods reported that studies funded by industry was of poorer quality.\nConclusion Systematic bias favours products which are made by the company funding the research. Explanations include the selection of an inappropriate comparator to the product being investigated and publication bias.", "publicationTitle": "BMJ", "publisher": "", "place": "", "date": "2003/05/29", "volume": "326", "issue": "7400", "section": "", "partNumber": "", "partTitle": "", "pages": "1167-1170", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "10.1136/bmj.326.7400.1167", "citationKey": "", "url": "http://www.bmj.com/content/326/7400/1167", "accessDate": "2015-04-08T13:54:31Z", "PMID": "12775614", "PMCID": "", "ISSN": "0959-8138, 1468-5833", "archive": "", "archiveLocation": "", "shortTitle": "Pharmaceutical industry sponsorship and research outcome and quality", "language": "en", "libraryCatalog": "www.bmj.com", "callNumber": "", "rights": "© 2003 BMJ Publishing Group Ltd.", "extra": "", "tags": [], "collections": [], "relations": {}, "dateAdded": "2015-04-08T13:54:31Z", "dateModified": "2015-04-08T13:54:31Z" } }, { "key": "XKNJRP6Q", "version": 25, "library": { "type": "group", "id": 342474, "name": "Open Trials", "links": { "alternate": { "href": "https://www.zotero.org/groups/open_trials", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/342474/items/XKNJRP6Q", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/open_trials/items/XKNJRP6Q", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/342474/items/NS7KZPGV", "type": "application/json" } }, "meta": { "createdByUser": { "id": 30496, "username": "jwyg", "name": "Jonathan W. 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