{"id":2271,"date":"2016-01-31T13:48:54","date_gmt":"2016-01-31T18:48:54","guid":{"rendered":"http:\/\/allphasepharma.com\/dir\/?p=2271"},"modified":"2016-03-23T04:39:08","modified_gmt":"2016-03-23T08:39:08","slug":"moving-towards-greater-transparency-one-step-at-a-time-inexorably","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2016\/01\/31\/2271\/moving-towards-greater-transparency-one-step-at-a-time-inexorably\/","title":{"rendered":"Moving Towards Greater Transparency \u2013 One Step At A Time, Inexorably"},"content":{"rendered":"

\"Cleaning<\/a><\/p>\n

Sharing trial data has been a controversial topic for quite a while. Recently the editors of major medical journals decided to take a stand. They will\u00a0make access to trial source data a requirement, as a condition of publication, arguing that patients and the scientific community have a right to this information.[1]<\/a><\/p>\n

The Clinicaltrials.gov website provides much useful information on development projects not easily available from other sources. Unfortunately, it is not being maintained; the results sections are often blank even after studies have long been completed. One can only speculate about the reasons for this; obviously\u00a0corrective action is necessary. FDA recently complained about this state of affairs and announced plans to clean up and penalize any non-compliant stragglers.<\/p>\n

Renowned institutions as well as pharma companies made the list of delinquents which reads like the Who is Who in drug development when the compliance status of Clinicaltrials.gov was reviewed in a recent publication.[2]<\/a>\u00a0\u00a0An article in the NEJM last year was an eye-opener: the results of only 17% of studies were made available in Clinicaltrials.gov\u00a0within a year of completion, as required.[3]<\/a>\u00a0 And after 5 years, still only 50% had the results section updated as required by law (see Figure from the NEJM article). Mind you, we are not talking about study publications here, just a short description of results in the database! This is an\u00a0embarrassing state of affairs not only for industry but for NIH studies as well.<\/p>\n

\"Clinical<\/a>
From: Anderson, NEJM 2015 – amended<\/figcaption><\/figure>\n

A few\u00a0companies have seen the writing on the wall and made some major concessions. In 2012, GSK CEO Andrew Witty agreed to make clinical trial data accessible to researchers upon request, with an independent panel of experts as gatekeepers. This was an industry first, and a major shift in philosophy and behavior for a Big Pharma company. Others have followed, and in 2014 J&J entered into an agreement with Yale\u2019s YODA (Open Data Access) Project to do the same.[4]<\/a>\u00a0 But not all have embraced transparency. Roche initially resisted all\u00a0efforts of independent researchers to gain access to the oseltamivir \/ Tamiflu clinical trial data sets. They relented eventually and opened their books but only so after an epic battle with BMJ investigators who literally had to fight for\u00a0full access.[5]<\/a><\/p>\n

Then there is the issue of publications being delayed or of data not being published at all because results were equivocal, not favorable enough, unfavorable, contradictory to prior results, or a combination\u00a0of these reasons. Pretty much all these delays are by design: a change of internal priorities. Hey, wake up: it\u2019s all about marketing and making a buck! \u00a0We are treated\u00a0to the frenzy of\u00a0Late Breakers\u00a0and First Results and Breaking News when data\u00a0\u2018good for marketing\u2019 are to be disseminated. Not so much for the other categories. Publishers and KOLs are complicit in this game of publishing selectively.<\/p>\n

Here some\u00a0suggestion for the main stakeholders:<\/p>\n

PATIENTS
\nDemand transparency as a condition of study participation, ie, publication of results in a reasonable timeframe after study\u00a0completion<\/p>\n

JOURNALS
\nDemand that full datasets be made public at the time of\u00a0<\/u>publication, not afterwards<\/p>\n

INVESTIGATORS
\nDemand control over the publication process, insist on timely publication, and expect to be held accountable for non-compliance<\/p>\n

COMPANIES \/ SPONSORS
\nPublish on time and engage neutral experts to review both the data, the data analysis and the publication; overcome your fears\u00a0that the competition may gain from open access. Remember, you will gain from it as well.<\/p>\n

FDA \/ EMA \/ HAs
\nDemand compliance with Clinicaltrials.gov requirements\u00a0at times of submission and approval.<\/p>\n

It has been too long that the \u201cMedical Information\u201d department was run by marketing folks in companies. Many \u201cMedical Affairs\u201d teams are still in a direct reporting line to the VP of Marketing. No wonder that publications are\u00a0prioritized based on commercialization goals.<\/p>\n

The game is afoot. There is change underway. As Gorbachev famously said to Honecker in 1989: \u201clife punishes those who come too late.”\u00a0 Half a year later the Berlin Wall came down…<\/p>\n

\n

FYI: There is a petition drive underway by AllTrials. You can sign up at their site if you support the push for greater data transparency.[6]<\/a><\/p>\n

References:
\n<\/strong>[1]<\/a> J Drazen. NEJM January 25, 2016 – DOI: 10.1056\/NEJMe1601087
\n[2]<\/a> J Miller. Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012. BMJ Open 2015;5: e009758. doi:10.1136\/bmjopen-2015-009758
\n[3]<\/a> M Anderson. Compliance with Results Reporting at ClinicalTrials.gov.\u00a0 N Engl J Med 2015;372:1031-9
\n[4]<\/a> http:\/\/news.yale.edu\/2014\/01\/30\/yale-program-s-agreement-johnson-johnson-allows-broad-access-clinical-trial-data
\n[5]<\/a> http:\/\/www.bmj.com\/tamiflu
\n[6]<\/a> http:\/\/www.alltrials.net\/<\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

Sharing trial data has been a controversial topic for quite a while. Recently the editors of major medical journals decided to take a stand. They will\u00a0make access to trial source data a requirement, as a condition of publication, arguing that patients and the scientific community have a right to this Continue reading Moving Towards Greater Transparency \u2013 One Step At A Time, Inexorably<\/span>→<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":2277,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[227,3,18],"tags":[1271,14,1504,56,1508,5,246,1583,523,638,1506,1503,184,10,1505,1507],"class_list":["post-2271","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-recent_literature","category-the_news","category-the_viewpoint","tag-allphase-pharma-consulting","tag-bmj","tag-clinical-data-access","tag-clinicaltrials-gov","tag-collaborations-for-independent-review","tag-fda","tag-gsk","tag-harald-reinhart","tag-jj","tag-nih","tag-oseltamivir","tag-publication-delays","tag-roche","tag-tamiflu","tag-transparency-for-clinical-trial-data","tag-yale-yoda"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/01\/Cleaning-Up-slider.jpg?fit=640%2C180&ssl=1","jetpack_shortlink":"https:\/\/wp.me\/p4KWFr-AD","jetpack_sharing_enabled":true,"jetpack-related-posts":[{"id":228,"url":"https:\/\/allphasepharma.com\/dir\/2014\/06\/03\/228\/and-the-results-are-pending\/","url_meta":{"origin":2271,"position":0},"title":"And the Results are \u2026Pending","author":"Harald","date":"June 3, 2014","format":false,"excerpt":"The website \u201cClinicalTrials.gov\u201d has become the first stop for many of us who need to check on trial activity of a particular drug.\u00a0 All larger human Phase 2 - 4 trials are listed there in quite some detail.\u00a0 While companies sometimes shy away from publishing full entry criteria or primary\u2026","rel":"","context":"In "The News"","block_context":{"text":"The News","link":"https:\/\/allphasepharma.com\/dir\/category\/the_news\/"},"img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]},{"id":2751,"url":"https:\/\/allphasepharma.com\/dir\/2016\/09\/21\/2751\/a-patch-yes-a-fix-no-this-emperor-has-no-clothes\/","url_meta":{"origin":2271,"position":1},"title":"A Patch? 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We noticed that Eastern European (EE) centers, specifically from Ukraine, Bulgaria, and Serbia, contribute patients in large numbers, actually making these trials feasible.\u00a0 When sponsors and CROs needed to enroll CABP patients, they could not rely\u2026","rel":"","context":"In "Did you know...?"","block_context":{"text":"Did you know...?","link":"https:\/\/allphasepharma.com\/dir\/category\/interesting_facts\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2025\/07\/image.png?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2025\/07\/image.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2025\/07\/image.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2025\/07\/image.png?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":1882,"url":"https:\/\/allphasepharma.com\/dir\/2015\/08\/23\/1882\/clinical-biofilm-studies-an-interesting-evolving-landscape\/","url_meta":{"origin":2271,"position":3},"title":"Clinical Biofilm Studies \u2013 An Interesting Evolving Landscape","author":"Harald","date":"August 23, 2015","format":false,"excerpt":"A recent article on \u201cAgents that Prevent Biofilm Formation\u201d captured my interest[1].\u00a0 The authors reviewed the literature and mentioned many substances which have shown in-vitro efficacy in disrupting biofilm production by the main offenders, i.e., S. aureus, S. epidermidis, P. aeruginosa and K. pneumoniae. These substances come with very diverse\u2026","rel":"","context":"In "Recent Literature"","block_context":{"text":"Recent Literature","link":"https:\/\/allphasepharma.com\/dir\/category\/recent_literature\/"},"img":{"alt_text":"BIOFILM - slider","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/08\/BIOFILM-slider.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/08\/BIOFILM-slider.jpg?resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/08\/BIOFILM-slider.jpg?resize=525%2C300 1.5x"},"classes":[]},{"id":1640,"url":"https:\/\/allphasepharma.com\/dir\/2015\/07\/04\/1640\/plazomicin-a-quick-take-on-a-complex-drug-with-a-complex-development-path\/","url_meta":{"origin":2271,"position":4},"title":"Plazomicin \u2013 A Quick Take On A Complex Drug\u00a0With A Complex Development Path","author":"Harald","date":"July 4, 2015","format":false,"excerpt":"Whenever a new drug is in late stage development, its prospects become the focus\u00a0of intense scrutiny. 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