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#AllTrials <https://twitter.com/search?q=%23AllTrials> Retroceso de la Agencia Europea del Medicamento respecto al acceso a los datos de ensayos clínicos. #AllTrials <https://twitter.com/search?q=%23AllTrials> *Backpedalling on European Medicine Agency’s "proactive publication of clinical-data" draft policy.* *Was it all just a window-dressing exercise? Who or what is the EMA afraid of? * It is online athttp://english.prescrire.org/en/ (1st item of the page!) Direct link:http://english.prescrire.org/en/79/207/46302/3553/3303/SubReportDetails.aspx El 20/05/2014 17:06, Juan Gérvas escribió: > -attached, the press release just on air (ISDB, Prescrire and more) > -about EMA and its “proactive publication of clinical-data” policy > -un saludo > -juan gérvas > > El 17/05/2014 20:10, Tom Jefferson escribió: >> Please blog away >> >> >> On 17 May 2014 11:23, Klim McPherson <[log in to unmask] >> <mailto:[log in to unmask]>> wrote: >> >> Also as the argument goes: 'If more transparency then many fewer >> RCT's and since regulatory approval 'demands' double blind RT 's >> evidence that presents problems in a world where side effects are >> purely a nuisance to manufacturers and often best swept under >> the carpet. >> >> klim >> >> From: healingjia Price <[log in to unmask] >> <mailto:[log in to unmask]>> >> Reply-To: healingjia Price <[log in to unmask] >> <mailto:[log in to unmask]>> >> Date: Saturday, 17 May 2014 10:00 >> To: "[log in to unmask] >> <mailto:[log in to unmask]>" >> <[log in to unmask] >> <mailto:[log in to unmask]>> >> Subject: Re: EMA's U Turn >> >> Financial interests and to reduce pre release opposition by such >> things as an evidence based critical appraisal of the data to >> prevent harm >> >> Sent from my iPhone >> >> On May 17, 2014, at 6:27 AM, "Zbys Fedorowicz" >> <[log in to unmask] <mailto:[log in to unmask]>> wrote: >> >>> Isn’t this actually a Y-TURN i.e. WHY? >>> >>> Prof Zbys Fedorowicz >>> >>> Director >>> >>> The Bahrain Branch of the UK Cochrane Centre >>> >>> The Cochrane Collaboration >>> >>> For information on the Bahrain branch see: >>> http://bahrain.cochrane.org/en/index.html >>> >>> *From:*Evidence based health (EBH) >>> [mailto:[log in to unmask]] *On Behalf Of *Tom >>> Jefferson >>> *Sent:* Saturday, May 17, 2014 12:29 AM >>> *To:* [log in to unmask] >>> <mailto:[log in to unmask]> >>> *Subject:* EMA's U Turn >>> >>> Is the Lady U-Turning? >>> >>> Peter Doshi, Tom Jefferson >>> >>> May 16, 2014 >>> >>> The EMA appears poised to make a major U-turn on its >>> transparency initiatives, reversing its principle of public >>> access to clinical trial data as its sets up a system of >>> controlled access similar to those independently established by >>> industry. This is a stunning and surprising reversal, >>> particularly as it comes after AbbView dropped its lawsuit >>> against EMA and after the passing of the European clinical >>> trials legislation which will require public access to clinical >>> study reports. If >>> finalized, the EMA’s new policy will prohibit a data requestor >>> from even printing out a redacted clinical study report: they >>> must instead read it in a so-called “view on-screen-only” mode. >>> In the first half of 2013, the EMA held a series of >>> teleconferences with its five advisory committees to obtain >>> guidance on developing a policy for the draft policy >>> on proactive publication of and access to clinical-trial data. >>> Individuals serving on the advisory committees came from >>> academia, industry, and other sectors. The process was open, >>> transparent, and inclusive. We served on some of these >>> advisory committees. The process culminated in the publication, >>> on June 24, 2013, of a draft policy document titled “Publication >>> and access to clinical-trial data” (EMA/240810/2013 >>> <tel:240810%2F2013>). The EMA invited public comments on this >>> document, and received more than 1,000 submissions from >>> stakeholders (http://tinyurl.com/k9a2plb). This week, the EMA is >>> discussing the finalization of its policy. Documents distributed >>> prior to the meeting indicate that a major U-turn is about to >>> occur. Under the draft Terms of Use policy document: “ the User >>> [data requestor] acknowledges that the Information [meaning >>> Clinical Study Reports as well as other types of documents] will >>> be made available to the User in a “view-on-screen-only” mode, >>> after completing the registration process. The User agrees that >>> the User is not permitted to >>> download, save, edit, photograph print, distribute or transfer >>> the Information. The User agrees not to access the Information >>> using a method other than the interface provided by the EMA, or >>> remove, bypass, circumvent, neutralise or modify any >>> technological protection measures which apply to the Information.” >>> >>> The EMA’s June 2013 draft policy document suggested that >>> clinical study reports were largely “open access” documents, >>> with only those sections containing individual participant data >>> necessitating a “controlled access” scheme (See Annex II of the >>> June 2013 draft policy). However, the new Terms of Use document >>> indicates that EMA now plans to treat clinical study reports as >>> “controlled access” documents. Taking the “public” out of >>> “publication” >>> While the draft policy is titled “Publication and access to >>> clinical-trial data,” it is no longer clear what—if any—data >>> will be published i.e. made public. The draft Terms of Use make >>> clear that Clinical Study Reports will not be published, but >>> instead only made accessible (but not downloadable, printable, >>> photographable, or salvable) to those granted access. >>> >>> Redacting Clinical Study Reports >>> >>> A separate draft “Redaction principles” policy document sets >>> forth a framework for redacting Clinical Study Reports. “In >>> general, much of the information in CSRs pertaining to study >>> designs, statistical analyses, and study results would >>> not be considered CCI [commercial confidential information],” >>> the EMA writes. The document however outlines the “limited >>> circumstances where such information could constitute CCI,” >>> leading to redactions. >>> For example, the EMA writes that “statements/descriptions >>> relating to objectives that are not supportive of a label claim >>> and do not contribute to the overall benefit/risk evaluation” >>> may be considered commercial confidential information, >>> and therefore redacted. This would appear to suggest that trials >>> for off-label uses of drugs will not be made available. However >>> the vague wording of the text leaves the door open to a variety >>> of interpretations, as the cook said the proof will be in the >>> pudding, but by the time proof is available it will be too late. >>> The document also suggests that “there may be occasions” when >>> the Clinical Study Report’s description of the sample size >>> calculation will be redacted. This >>> could occur, the EMA writes, when information used in the >>> calculation “is considered CCI,” but it is unclear who would >>> make this determination. CSR(a) and CSR(b) >>> >>> Perhaps most surprising is the concept of “CSR (a)” and “CSR >>> (b)”. Under thisscheme, sponsors submitting Clinical Study >>> Reports as part of their marketing authorization application >>> would submit two Clinical Study Reports for each trial: a >>> standard one (CSR(a)) and one redacted one (CSR(b)). The scheme >>> puts primary responsibility for redacting in the hands of >>> sponsors. “If EMA disagrees” with some of the redactions, “the >>> Consultation Process is initiated,” presumably >>> until the sponsor and EMA agree. How close CSR(a) is to CSR(b), >>> and what parts are missing, may never be known to third party >>> data requestors. >>> >>> Irony >>> The irony of EMA’s apparent U-turn is that since late 2010, >>> while the EMA has been deliberating over its “prospective” >>> policy, there was a separate “reactive” policy in place. This >>> was to release the “legacy” clinical study reports not covered >>> by their “prospective” policy. Under this the agency has >>> released 2 million pages of clinical study reports and other >>> internal documents. These documents were released >>> electronically, with no restrictions on use, re-use, or >>> distribution, and at no-cost. Clinical study reports were often >>> completely unredacted, such as the over 20,000 pages of Clinical >>> Study Reports we received for oseltamivir (Tamiflu).1–3 >>> >>> If the draft policy goes live on 12th of June as scheduled >>> unchallenged, working on clinical study reports to circumvent >>> the problems of reporting bias will become even more difficult. >>> Remote viewing and impossibility of analyzing and cross >>> checking (the kind of activity which is necessary) will be more >>> difficult and the constraints of screen shots will make >>> navigation well-near impossible. Is this the aim of the U-turn? >>> >>> Peter Doshi, assistant professor, Department of Pharmaceutical >>> Health Services >>> Research, University of Maryland School of Pharmacy, Baltimore, >>> MD 21201, >>> USA, [log in to unmask] <mailto:[log in to unmask]> >>> >>> Tom Jefferson, Reviewer, Cochrane Acute Respiratory Infections >>> Group, 00187, >>> Roma, Italy. [log in to unmask] >>> <mailto:[log in to unmask]> >>> >>> Disclosures >>> Both authors are co-recipients of a UK National Institute for >>> Health Research grant (HTA - 10/80/01 Update and amalgamation of >>> two Cochrane Reviews: neuraminidase inhibitors for preventing >>> and treating influenza in healthy adults >>> and children - http://www.nets.nihr.ac.uk/projects/hta/108001). >>> In addition: Dr Doshi received €1500 from the European >>> Respiratory Society in support of his travel to the society’s >>> September 2012 annual congress in Vienna, where he >>> gave an invited talk on oseltamivir. Dr Doshi is an Associate >>> Editor of The BMJ. Dr Jefferson receives royalties from his >>> books published by Blackwells and Il Pensiero Scientifico >>> Editore, Rome. Dr Jefferson is occasionally interviewed by >>> market research companies for anonymous interviews about Phase 1 >>> or 2 pharmaceutical products. In 2011-2013 Dr Jefferson acted as >>> an expert witness in a litigation case related to oseltamivir >>> phosphate; Tamiflu [Roche] and in a >>> labour case on influenza vaccines in health care workers in >>> Canada. In 1997-99 Dr Jefferson acted as consultant for Roche, >>> in 2001-2 for GSK and in 2003 for Sanofi-Synthelabo for >>> pleconaril (an anti-rhinoviral which did not get approval >>> from FDA). Dr Jefferson was a consultant for IMS Health in 2013 >>> and is currently retained as a scientific advisor to a legal >>> team acting on the drug Tamiflu (oseltamivir, Roche). >>> >>> >>> References >>> 1.Doshi P, Jefferson T. The first 2 years of the European >>> Medicines Agency’s policy on access to documents: secret no >>> longer. JAMA Intern Med. 2013 Mar 11;173(5):380–2. >>> >>> 2. Doshi P. Transparency interrupted: The curtailment of the >>> European Medicines Agency’s policy on access to documents. JAMA >>> Intern Med [Internet]. 2013 Aug 19 [cited 2013 Aug 20]; >>> Available from: >>> http://dx.doi.org/10.1001/jamainternmed.2013.9989 >>> >>> 3. Jefferson T, Doshi P. Multisystem failure: the story of >>> anti-‐influenza drugs. BMJ. 2014;348:g2263. >>> >> >> >> >> -- >> Dr Tom Jefferson >> Medico Chirurgo >> GMC # 2527527 >> www.attentiallebufale.it <http://www.attentiallebufale.it> > --- Este mensaje no contiene virus ni malware porque la protección de avast! Antivirus está activa. http://www.avast.com