New Rules for Publishing Clinical Trials
Back in December of 2005 I mentioned the clinicaltrials.gov web site. This site, where many large multi-center clinical trials are registered online, was primarily intended to store information on research being sponsored by the National Institutes of Health.
That site, and several others like it, expanded considerably as a result of a 2005 policy implemented by the International Committee of Medical Journal Editors. The ICMJE, as it is known, is a very influential group of the world’s most prestigious journal editors. Much of the leading clinical research is published in these medical journals.
In 2005, the ICMJE established the policy that authors wishing to submit manuscripts for consideration in any of the ICMJE journals which described the results of clinical trials could only do so if the clinical trials were registered with one of the online clinical trial registries, such as clinicaltrials.gov. Since that policy was established, the number of clinical trials registered on clinicaltrials.gov more than tripled, to over 40,000 today.
The ICMJE was criticized for at least two major flaws in its policy. First, it did not cover the earliest kind of research, Phase I clinical trials, which are usually designed to test the safety of a new compound or device in a relatively small population of research participants. Second, because the policy required that results of the clinical trials also be published online, many manuscripts were turned down for publication because the results had, in effect, already been published (online).
Fast forward to June of 2007.
This month, the ICMJE updated its policy to include Phase I clinical trials. This means that, for any clinical trial in which participants are enrolled on or after July 1, 2008, even if they are only small trials designed to see how toxic a potential new drug is, they must have been registered online in order to be eligible for consideration as publications in any of the ICMJE journals.
Many physician-scientists who conduct clinical trials are interested in publishing their results in prestigious journals so they can progress in their academic fields. They will not be able to publish in ICMJE journals if the clinical trials they conduct have not been registered.
Why would they NOT want to register the trials in the first place? Such pressure usually comes from the drug company sponsoring a particular clinical trial. For strategic business reasons, companies do not want to give away any information on its research and development activities, especially so early in the process. Not only does it potentially tip the company's hand to competitors, investors may be scared away by published scientific reports of "failed" ideas.
The second perceived flaw in the ICMJE policy, the paradox created by requiring online publication of results, making those results less valuable for publication in journals, was also addressed. ICMJE journals will now treat results that are published in the same online registry in which the clinical trial itself was published as brief abstracts (brief being defined as less than 500 words) or as tables of data as though they had not been previously published at all. Therefore, the results, when submitted to the journals as fully developed scientific manuscripts, would be acceptable to the journals.
Yes, these represent baby steps. But they are baby steps forward and do represent movement toward greater transparency when it comes to testing compounds which will be used to treat people.
~Joe
Related Topics:
Technorati Tags: clinical trials, ICJME, pharmaceutical
That site, and several others like it, expanded considerably as a result of a 2005 policy implemented by the International Committee of Medical Journal Editors. The ICMJE, as it is known, is a very influential group of the world’s most prestigious journal editors. Much of the leading clinical research is published in these medical journals.
In 2005, the ICMJE established the policy that authors wishing to submit manuscripts for consideration in any of the ICMJE journals which described the results of clinical trials could only do so if the clinical trials were registered with one of the online clinical trial registries, such as clinicaltrials.gov. Since that policy was established, the number of clinical trials registered on clinicaltrials.gov more than tripled, to over 40,000 today.
The ICMJE was criticized for at least two major flaws in its policy. First, it did not cover the earliest kind of research, Phase I clinical trials, which are usually designed to test the safety of a new compound or device in a relatively small population of research participants. Second, because the policy required that results of the clinical trials also be published online, many manuscripts were turned down for publication because the results had, in effect, already been published (online).
Fast forward to June of 2007.
This month, the ICMJE updated its policy to include Phase I clinical trials. This means that, for any clinical trial in which participants are enrolled on or after July 1, 2008, even if they are only small trials designed to see how toxic a potential new drug is, they must have been registered online in order to be eligible for consideration as publications in any of the ICMJE journals.
Many physician-scientists who conduct clinical trials are interested in publishing their results in prestigious journals so they can progress in their academic fields. They will not be able to publish in ICMJE journals if the clinical trials they conduct have not been registered.
Why would they NOT want to register the trials in the first place? Such pressure usually comes from the drug company sponsoring a particular clinical trial. For strategic business reasons, companies do not want to give away any information on its research and development activities, especially so early in the process. Not only does it potentially tip the company's hand to competitors, investors may be scared away by published scientific reports of "failed" ideas.
The second perceived flaw in the ICMJE policy, the paradox created by requiring online publication of results, making those results less valuable for publication in journals, was also addressed. ICMJE journals will now treat results that are published in the same online registry in which the clinical trial itself was published as brief abstracts (brief being defined as less than 500 words) or as tables of data as though they had not been previously published at all. Therefore, the results, when submitted to the journals as fully developed scientific manuscripts, would be acceptable to the journals.
Yes, these represent baby steps. But they are baby steps forward and do represent movement toward greater transparency when it comes to testing compounds which will be used to treat people.
~Joe
Related Topics:
Technorati Tags: clinical trials, ICJME, pharmaceutical
1 Comments:
Once again, there are new rules for publishing clinical trials, with the enactment of Public Law 110-85 [http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf], Section 801: "Expanded Clinical Trial Registry Data Bank" on Sept. 27, 2007. The law, which includes enforcement provisions and penalities for non-compliance (e.g., civil monetary penalities), expands the scope of ClinicalTrials.gov [http://clinicaltrials.gov/] -- now 47,000 registrations -- in several ways: e.g.,
(1) Expanding the registry, including device clinical trials; trials (except phase I) of all diseases and conditions, not just those that are "serious or life-threatening"; and nearly all of the information required by the June 2007 ICMJE registration policy [href="http://www.icmje.org/clin_trial07.pdf] (the remainder may be submitted voluntarily to comply fully with ICMJE policy). More information on the expanded registry is available at http://prsinfo.clinicaltrials.gov/fdaaa.html
(2) Basic results reporting for completed clinical trials by Sept 2007, whether published or not, including demographic and baseline characteristics of patient sample; primary and secondary outcomes; and adverse events in early 2009 (serious adverse events and frequent adverse events).
Thus, due to efforts of the ICMJE policy and the new law, neglecting to register clinical trials or disseminate results -- including "failed" ideas -- will NO LONGER be an option. There is clearly a trend towards increased transparency in clinical research.
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