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Opinions on registering trial details: a survey of academic researchers.

Scherer M, Trelle S - BMC Health Serv Res (2008)

Bottom Line: Disclosing study documents, in particular the study protocol and financial agreements, was found to be most problematic with only 31% of respondents willing to disclose these publicly.Principal investigators of non-industry sponsored studies are reluctant to disclose all data items proposed by the Ottawa Group.Disclosing the study protocol and financial agreements was found to be most problematic.

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Affiliation: Department of General Practice, University of Göttingen, Humboldtallee 38, 37073 Göttingen, Germany. mschere@gwdg.de

ABSTRACT

Background: The World Health Organization (WHO) has established a set of items related to study design and administrative information that should build the minimum set of data in a study register. A more comprehensive data set for registration is currently developed by the Ottawa Group. Since nothing is known about the attitudes of academic researchers towards prospective study registration, we surveyed academic researchers about their opinion regarding the registration of study details proposed by the WHO and the Ottawa Group.

Methods: This was a web-based survey of academic researchers currently running an investigator-initiated clinical study which is registered with clinicaltrials.gov. In July 2006 we contacted 1299 principal investigators of clinical studies by e-mail explaining the purpose of the survey and a link to access a 52-item questionnaire based on the proposed minimum data set by the Ottawa Group. Two reminder e-mails were sent each two weeks apart. Association between willingness to disclose study details and study phase was assessed using the chi-squared test for trend. To explore the potential influence of non-response bias we used logistic regression to assess associations between factors associated with non-response and the willingness to register study details.

Results: Overall response was low as only 282/1299 (22%) principal investigators participated in the survey. Disclosing study documents, in particular the study protocol and financial agreements, was found to be most problematic with only 31% of respondents willing to disclose these publicly. Consequently, only 34/282 (12%) agreed to disclose all details proposed by the Ottawa Group. Logistic regression indicated no association between characteristics of non-responders and willingness to disclose details.

Conclusion: Principal investigators of non-industry sponsored studies are reluctant to disclose all data items proposed by the Ottawa Group. Disclosing the study protocol and financial agreements was found to be most problematic. Future discussions on trial registration should not only focus on industry but also on academic researchers.

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Willingness to disclose study details. For description of each data set see Table 1.
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Figure 2: Willingness to disclose study details. For description of each data set see Table 1.

Mentions: Sixty-eight responders (24%) were willing to disclose all items required by the WHO – and clinicaltrials.gov. Only 34/282 (12%) agreed to disclose all details proposed by the Ottawa Group (Figure 2).


Opinions on registering trial details: a survey of academic researchers.

Scherer M, Trelle S - BMC Health Serv Res (2008)

Willingness to disclose study details. For description of each data set see Table 1.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2245930&req=5

Figure 2: Willingness to disclose study details. For description of each data set see Table 1.
Mentions: Sixty-eight responders (24%) were willing to disclose all items required by the WHO – and clinicaltrials.gov. Only 34/282 (12%) agreed to disclose all details proposed by the Ottawa Group (Figure 2).

Bottom Line: Disclosing study documents, in particular the study protocol and financial agreements, was found to be most problematic with only 31% of respondents willing to disclose these publicly.Principal investigators of non-industry sponsored studies are reluctant to disclose all data items proposed by the Ottawa Group.Disclosing the study protocol and financial agreements was found to be most problematic.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of General Practice, University of Göttingen, Humboldtallee 38, 37073 Göttingen, Germany. mschere@gwdg.de

ABSTRACT

Background: The World Health Organization (WHO) has established a set of items related to study design and administrative information that should build the minimum set of data in a study register. A more comprehensive data set for registration is currently developed by the Ottawa Group. Since nothing is known about the attitudes of academic researchers towards prospective study registration, we surveyed academic researchers about their opinion regarding the registration of study details proposed by the WHO and the Ottawa Group.

Methods: This was a web-based survey of academic researchers currently running an investigator-initiated clinical study which is registered with clinicaltrials.gov. In July 2006 we contacted 1299 principal investigators of clinical studies by e-mail explaining the purpose of the survey and a link to access a 52-item questionnaire based on the proposed minimum data set by the Ottawa Group. Two reminder e-mails were sent each two weeks apart. Association between willingness to disclose study details and study phase was assessed using the chi-squared test for trend. To explore the potential influence of non-response bias we used logistic regression to assess associations between factors associated with non-response and the willingness to register study details.

Results: Overall response was low as only 282/1299 (22%) principal investigators participated in the survey. Disclosing study documents, in particular the study protocol and financial agreements, was found to be most problematic with only 31% of respondents willing to disclose these publicly. Consequently, only 34/282 (12%) agreed to disclose all details proposed by the Ottawa Group. Logistic regression indicated no association between characteristics of non-responders and willingness to disclose details.

Conclusion: Principal investigators of non-industry sponsored studies are reluctant to disclose all data items proposed by the Ottawa Group. Disclosing the study protocol and financial agreements was found to be most problematic. Future discussions on trial registration should not only focus on industry but also on academic researchers.

Show MeSH
Related in: MedlinePlus