Regulatory Focus™ > News Articles > Study: Pediatric Clinical Trials Guilty of Publication Bias, NIH Falling Short of Obligations

Study: Pediatric Clinical Trials Guilty of Publication Bias, NIH Falling Short of Obligations

Posted 24 April 2012 | By Alexander Gaffney, RAC 

An examination of 2,385 completed pediatric clinical trials has found 71% were never published, reports Pharmalot.

The study, Pediatric Clinical Trial Registration and Trial Results: An Urgent Need for Improvement, was published in the 23 April edition of the medical journal Pediatrics.

The study looked at 3,428 closed studied involving children, of which 2,385 were completed, 28 suspended, 125 terminated and 38 withdrawn.

The study's authors, Tatyana Shamliyan, MD and Robert Kane, MD, identified a potentially troubling 186% increase in the number of terminated and suspended clinical trials involving children between 2001 and 2009.

This represents "a substantial publication bias," wrote Shamliyan and Kane, who called for all trials to be published.

Noting that pediatric-focused research is "critical to providing proper pediatric medical care," Scott C. Denne, MD opined in an accompanying opinion piece that the lack of publication of such studies violates ethical guidelines surrounding pediatric trials.

To do otherwise risks repeating trials "unnecessarily," explained Dunne.

The study also identified a number of surprising findings. Only 53% of National Institutes of Health-sponsored studies appear to have been published in violation of the agency's own rules, noted the authors.

"Although mandatory registration of applicable clinical trials involving children would improve transparency in research, less than half of federally funded studies involving children were registered on ClinicalTrials.gov," explained Shamliyan and Kane.

The issue is not altogether unfamiliar to government agencies and legislators.

The US Food and Drug Administration (FDA) noted in a 6 March report on postmarketing obligations under the FDA Amendments Act that 49% of unfulfilled obligations were for pediatric clinical trials, while a US Institute of Medicine (IOM) issued a report 29 February calling for the expansion of pediatric studies.

Legislation introduced 18 April by Sens. Reed (D-RI), Alexander (R-TN), Murray (D-WA) and Roberts (R-KS) would mandate manufacturers submit pediatric clinical trial plans to FDA by the end of Phase II clinical testing and provide retroactive public disclosures for all pediatric clinical trial results going back to 2002.


Read more:

Pharmalot - Many Pediatric Studies Remain Unpublished

Pediatric Clinical Trial Registration and Trial Results: An Urgent Need for Improvement

Pediatrics - Pediatric Clinical Trial Registration and Trial Results: An Urgent Need for Improvement

Regulatory Focus - IOM: Legislation Has Led To Safer Medicines For Children, More Work Needed

Regulatory Focus - FDA Releases Report on Postmarketing Study Requirements

Regulatory Focus - Senators Release Plan to Improve Pediatric Device, Drug Safety


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