Panel: Open Access- Peter Doshi
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Panel: Open Access- Peter Doshi

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  • Unpublished studies.Paint a different story.
  • Misreporting. Paints a distorted story.Invisibility and Distortion are all over the literature – many diseases, many drugs.There is a need for access to trial data.
  • Explain: data under waterline is data from patients, recorded onto CRF, then into database. De-identified, but patient level.Invisibility (Nissen) & Distortion (Celebrex)
  • Castellani makes several points.Clinical Trials are important. “Clinical trials are essential for the successful development of new medicines that save and improve lives and provide hope for millions of patients.”Pharma is the innovator. “Since 2000, PhRMA member companies have invested about $550bn (£330bn; €390bn) in research and development, including clinical trials, in the search for new treatments and cures. No government or academic institution has the resources or multidisciplinary expertise to conduct the clinical trials needed to develop the new medicines patients need.”The system is working. “The modern clinical trial system and associated sharing of information led to more than 340 new medicines approved by the FDA over the past decade”Pharma already shares data. “The biopharmaceutical industry is firmly committed to enhancing public health through responsible reporting and publication of clinical research and safety information. … the current biomedical research system includes wide sharing of trial results with government regulators, academic and medical communities, and physicians through submissions to the US Food and Drug Administration (FDA) and other international regulatory bodies, presentations at medical conferences, and publication in peer reviewed journals.”Data are dangerous. “Dumping millions of pages of clinical trial information into the public domain without providing appropriate scientific and clinical context or guidelines for meta-analysis could lead to second guessing of the expert decisions of national regulators worldwide, undermining patient trust and confidence in the safety and effectiveness of approved medicines.”
  • 400 patients in this trial.With funding, access to the CSR would allow for checking to ensure the published record is accurate.Even without funding, just the threat of being able to check serves as a deterrent to misreporting.
  • Good news? EMA forging ahead despite court case
  • Bad news? FDA way behind.Why this matters? EMA is incomplete.
  • Good news? Tide of public opinion is turning
  • Bad news? This may not be an easy fight.http://www.guardian.co.uk/business/2013/jul/21/big-pharma-secret-drugs-trialsTHE FOUR PRONGED STRATEGY1. "mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data".2,3. Two other strands of the campaign include discussions with scientific associations about the risks of data sharing, and work with other businesses that are concerned about the release of trade secrets and confidential data. 4. final strand calls, in the long term, for a network of academics across Europe that can be called on to correct false interpretations of the data. "That is deemed to be happening in any case," the memo concedes.http://www.eatg.org/news/168640/Official_EPF_Statement_to_clarify_The_Guardian%27s_article_%E2%80%9CBig_pharma_mobilising_patients_in_battle_over_drugs_trials_data%E2%80%9D
  • CUE has signed…. But check on your logo.

Panel: Open Access- Peter Doshi Panel: Open Access- Peter Doshi Presentation Transcript

  • GLOBAL INITIATIVES TO OPEN ACCESS TO CLINICAL TRIAL DATA Peter Doshi July 26, 2013
  • Spitzer v. GSK Consent Order August 26, 2004 Nissen and Wolski May 2007 (e-pub)
  • “As described on the FDA Web site, the published CLASS trial differs from the original protocol in primary outcomes, statistical analysis, trial duration, and conclusions. In particular, the unpublished data show that by week 65, celecoxib was associated with a similar number of ulcer complications as diclofenac and ibuprofen.” Hrachovec JB, Mora M. JAMA. 2001;286(19):2398-2400. 2000-2001
  • Doshi P, Dickersin K, Healy D, Vedula SS, Jefferson T. Restoring invisible and abandoned trials: a call for people to publish the findings. BMJ. 2013 Jun 13;346:f2865.
  • John Castellani is the President & Chief Executive Officer of the Pharmaceutical Research and Manufacturers of America (PhRMA). Ben Goldacre is a best-selling author, broadcaster, campaigner, medical doctor and academic
  • Reactive release of documents The Agency has been releasing documents [>1.9 million pages so far] submitted as part of applications for marketing authorisation on request since November 2010 … including clinical-trial reports, once the decision-making process for the medicine in question has been completed. Proactive publication of data The Agency has committed to the proactive publication of the data from clinical trials supporting the authorisation of medicines. This will enable the independent re-analysis of the evidence used by the Agency's committees to determine their benefits and risks and is expected to lead to public- health benefits.
  • 8545 pages 8000 7000 6000 5000 4000 3000 2000 1000 One full clinical study report (Roche Tamiflu study WP16263) Same trial – 7 pages in a medical journal
  • Arguments against sharing data • Industry • Misleading analyses • Commercial confidential information • Patient privacy/confidentiality • Too much work • Not everybody needs so much detail • Academics • Too much work • No money • Unclear how to share • Promotion/career
  • http://www.ema.europa.eu/
  • Publication and access to clinical-trial data June 24, 2013 http://www.ema.europa.eu/docs/en_GB/docu ment_library/Other/2013/06/WC500144730.p df 16 pages “The Agency respects and will not divulge commercially confidential data or information. In general, however, CT data cannot be considered CCI; the interests of public health outweigh considerations of CCI.” “Access to CT data … will make drug development more efficient … learn from past successes and failures … develop new knowledge in the interest of public health … promote better-informed use of medicines … enable third parties to verify the regulatory authority’s positions and challenge them where appropriate.” Deadlineforcomments:Sep30 2013
  • “The contribution of patients who participate in clinical trials should be maximized for the benefit of society.” “We note that this proposal contemplates the availability of certain data after appropriate steps have been taken to de-identify it and remove the data's link to a specific product, study, or application. This proposal does not pertain to unmasked safety and effectiveness data, (i.e., data that can be linked to a specific, identified application) including full study reports”
  • The New York Times June 30, 2013 p.B1 July 5, 2013 p.A18
  • http://www.guardian.co.uk/business/2013/jul/21/big-pharma-secret-drugs-trials “Our engagement in the „ALLTrials campaign‟ indicates also our unequivocal commitment to disclosure and transparency.”
  • What can you do? Take action!
  • http://www.AllTrials.net/
  • http://tinyurl.com/fda-rfc http://tinyurl.com/ema-rfc US and European Regulatory policies on access to data are open for comment