Re: Majority of Clinical Trials Don't Provide Meaningful Evidence

[Guest guest]

This is a classic example of sloppy journalism. The headline and the

introductory sentence appear to be extremely misleading in the context of the

publication content upon which the article is based.

I'm including the abstract below. If anyone has access to the entire article,

I'd love to read it.

mark

Nashville TN

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Characteristics of Clinical Trials Registered in ClinicalTrials.gov, 2007-2010

M. Califf, MD;

Deborah A. Zarin, MD;

Judith M. Kramer, MD, MS;

E. Sherman, MD, MPH;

H. Aberle, BSPH;

Asba Tasneem, PhD

[+] Author Affiliations

Author Affiliations: Duke Translational Medicine Institute, Durham, North

Carolina (Drs Califf and Kramer); National Library of Medicine, National

Institutes of Health, Bethesda, land (Dr Zarin); Office of Medical Policy,

Center for Drug Evaluation and Research, US Food and Drug Administration, Silver

Spring, land (Dr Sherman); and Duke Clinical Research Institute, Durham (Drs

Kramer and Tasneem and Ms Aberle).

Abstract

Context Recent reports highlight gaps between guidelines-based treatment

recommendations and evidence from clinical trials that supports those

recommendations. Strengthened reporting requirements for studies registered with

ClinicalTrials.gov enable a comprehensive evaluation of the national trials

portfolio.

Objective

To examine fundamental characteristics of interventional clinical trials

registered in the ClinicalTrials.gov database.

Methods

A data set comprising 96 346 clinical studies from ClinicalTrials.gov was

downloaded on September 27, 2010, and entered into a relational database to

analyze aggregate data. Interventional trials were identified and analyses were

focused on 3 clinical specialties—cardiovascular, mental health, and

oncology—that together encompass the largest number of disability-adjusted

life-years lost in the United States.

Main Outcome Measures

Characteristics of registered clinical trials as reported data elements in the

trial registry; how those characteristics have changed over time; differences in

characteristics as a function of clinical specialty; and factors associated with

use of randomization, blinding, and data monitoring committees (DMCs).

Results

The number of registered interventional clinical trials increased from 28 881

(October 2004–September 2007) to 40 970 (October 2007–September 2010), and the

number of missing data elements has generally declined. Most interventional

trials registered between 2007 and 2010 were small, with 62% enrolling 100 or

fewer participants. Many clinical trials were single-center (66%; 24 788/37 520)

and funded by organizations other than industry or the National Institutes of

Health (NIH) (47%; 17 592/37 520). Heterogeneity in the reported methods by

clinical specialty; sponsor type; and the reported use of DMCs, randomization,

and blinding was evident. For example, reported use of DMCs was less common in

industry-sponsored vs NIH-sponsored trials (adjusted odds ratio [OR], 0.11; 95%

CI, 0.09-0.14), earlier-phase vs phase 3 trials (adjusted OR, 0.83; 95% CI,

0.76-0.91), and mental health trials vs those in the other 2 specialties. In

similar comparisons, randomization and blinding were less frequently reported in

earlier-phase, oncology, and device trials.

Conclusion

Clinical trials registered in ClinicalTrials.gov are dominated by small trials

and contain significant heterogeneity in methodological approaches, including

reported use of randomization, blinding, and DMCs.

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> http://www.sciencedaily.com/releases/2012/05/120501162702.htm

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