{"id":2751,"date":"2016-09-21T14:01:35","date_gmt":"2016-09-21T18:01:35","guid":{"rendered":"http:\/\/allphasepharma.com\/dir\/?p=2751"},"modified":"2016-09-26T08:07:28","modified_gmt":"2016-09-26T12:07:28","slug":"a-patch-yes-a-fix-no-this-emperor-has-no-clothes","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2016\/09\/21\/2751\/a-patch-yes-a-fix-no-this-emperor-has-no-clothes\/","title":{"rendered":"A Patch? YES – A Fix? NO: This Emperor Has No Clothes"},"content":{"rendered":"

\"enforcer-slider\"<\/a><\/p>\n

The NIH Department of HHS released its Final Rule on \u201cClinical Trials Registration and Results Information Submission\u201d [1]<\/a>. This Rule is meant to address frustrating maintenance and compliance issues in the ClinicalTrials.gov database, especially the results reporting section which has been neglected or totally ignored, (we commented on this in prior blogs).<\/p>\n

The main issue has always been that trial results were provided much too late or worse, not at all. Even in the absence of a publication, society and patients are entitled to learn about trial results, and Clinicaltrials.gov is meant to be the repository of this information.<\/p>\n

There is simply no excuse for the lackadaisical way this database is currently administered (the word ‘maintained’ would be too kind) and the shoddy oversight that let companies and organisations\u00a0skirt their regulatory responsibilities.<\/p>\n

We are quick to assume sinister motives when favorable study results are publicized expeditiously but others are not. Selective reporting and preferential push of publication with ‘good’ results takes on all kinds of forms but Clinicaltrials.gov should be above the fray: a neutral source of core information after the data has been cleaned and analyzed. Just the facts, please! \u00a0No spin-doctoring, no framing.<\/p>\n

There has always been a federal mandate to provide trial information as much as there was a mandate to register a trial in the first place. Have you ever heard of regulatory action against a delinquent company or institution that kept study results unpublished for years after trial completion? There is not a single such case since Clinicaltrials.gov came into existence (around 2003). The 600+ pages of the new Rule dutifully provide references for this sad state of regulatory oversight and major\u00a0lack of compliance. At the end one\u00a0does not know whom to blame more: the sheep for trashing up the place or the shepherd for not wielding a stick.

The new 2016 Rule\u00a0it a blunt weapon unlikely to generate better\u00a0compliance.<\/span><\/p>\n<\/div><\/p>\n

Well, the new Rule has\u00a0a new Section 11.66<\/span> which describes the penalties for non-compliance. Most of the punitive action is reserved for submitting false\u00a0information and for\u00a0non-compliance with submitting \u201cClinical Trial Information\u201d. Please note: Summary results information is<\/span>\u00a0a part of Clinical Trial Information and as such was a\u00a0required deliverable since 2008 already.<\/p>\n

If non-compliance, i.e., not submitting study results as part of “Clinical Trial Information” is a punishable\u00a0offense, why are we where we are? With the threat of penalties already in the 2008 Rule; repeating the same threats for non-compliance and\u00a0hoping for a different outcome seems\u00a0illogical.<\/p>\n

<\/p>\n

The Rule deals with a lot more than just results reporting, for sure, but the main thrust\u00a0should still be:\u00a0 Show us the study result data, STUPID!<\/strong><\/span><\/p>\n<\/div>\n

We believe Clinicaltrials.gov should run like a well-greased engine, well-maintained by study sponsors, monitored for compliance by HHS \/ NIH. There need to be significant\u00a0consequences\u00a0for non-compliance, nothing else will do. Let\u2019s not continue the indifferent laid-back\u00a0approach which was in place far too long.<\/p>\n

Hey FDA, this could become your next self-funding tool!\u00a0 The charges for non-compliance\u00a0could\u00a0easily pay for your\u00a0new headcount to administer Clinicaltrials.gov (and some more).<\/p>\n

 <\/p>\n

References:
\n<\/strong>[1]<\/a> RIN: 0925-AA55: Clinical Trials Registration and Results Information Submission. Final Rule.\u00a0This document is scheduled to be published in the Federal Register on 09\/21\/2016 and available online at\u00a0https:\/\/federalregister.gov\/d\/2016-22129<\/strong>, and on FDsys.gov<\/strong><\/p>\n

 <\/p>\n

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

The NIH Department of HHS released its Final Rule on \u201cClinical Trials Registration and Results Information Submission\u201d [1]. This Rule is meant to address frustrating maintenance and compliance issues in the ClinicalTrials.gov database, especially the results reporting section which has been neglected or totally ignored, (we commented on this in Continue reading A Patch? YES – A Fix? NO: This Emperor Has No Clothes<\/span>→<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":2752,"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":[1271,403,1748,56,1744,1750,5,1583,1747,638,1749,1745,1746],"class_list":["post-2751","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-antibiotic-blog","tag-clinical-trials-registration-and-results-information-submission","tag-clinicaltrials-gov","tag-compliance-with-regulations","tag-enforcement-of-reporting-requirements","tag-fda","tag-harald-reinhart","tag-hhs","tag-nih","tag-penalties-for-non-compliance","tag-reporting-of-trial-results","tag-studies-without-publications"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/09\/Enforcer-slider.jpg?fit=640%2C180&ssl=1","jetpack_shortlink":"https:\/\/wp.me\/p4KWFr-In","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":2751,"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":2271,"url":"https:\/\/allphasepharma.com\/dir\/2016\/01\/31\/2271\/moving-towards-greater-transparency-one-step-at-a-time-inexorably\/","url_meta":{"origin":2751,"position":1},"title":"Moving Towards Greater Transparency \u2013 One Step At A Time, Inexorably","author":"Harald","date":"January 31, 2016","format":false,"excerpt":"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\u2026","rel":"","context":"In "Recent Literature"","block_context":{"text":"Recent Literature","link":"https:\/\/allphasepharma.com\/dir\/category\/recent_literature\/"},"img":{"alt_text":"Cleaning Up - slider","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/01\/Cleaning-Up-slider.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/01\/Cleaning-Up-slider.jpg?resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/01\/Cleaning-Up-slider.jpg?resize=525%2C300 1.5x"},"classes":[]},{"id":4745,"url":"https:\/\/allphasepharma.com\/dir\/2025\/07\/18\/4745\/cabp-trial-enrollment-but-not-in-the-usa\/","url_meta":{"origin":2751,"position":2},"title":"CABP TRIAL ENROLLMENT \u2013 BUT NOT IN THE USA","author":"Harald","date":"July 18, 2025","format":false,"excerpt":"Today\u2019s topic is about the lackluster recruitment of US centers in recent CABP trials. 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