Reporting clinical trials: full access to all the data

Rosenberg, Roger N.; Aminoff, Michael J.; Boller, François; Soerensen, Per Soelberg; Griggs, Robert C.; Hachinski, Vladimir; Hallett, Mark; Johnson, Richard T.; Kennard, Christopher; Lang, Anthony E.; Lees, Andrew; Lisak, Robert P.; Newsom‐Davis, John; Pedley, Timothy A.; Selzer, Michael E.; Zochodne, Douglas W.

doi:10.1093/brain/awf120

Cited by 3 publications

(5 citation statements)

References 3 publications

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“…221 The primary outcome should be clinically relevant to patients, and ideally, the effects of the treatment on the primary outcome should impact medical practice. To ensure accurate data reporting, investigators need to have full access to data from industry sponsored trials, 223 and all results should be reported accurately, completely, and in context. Which primary outcome measure is selected will affect the sample size and study design.…”

Section: Measuring Progression and Outcome Measuresmentioning

confidence: 99%

Translational Research in ALS

Montes

Bendotti

Tortarolo

et al. 2008

Animal and Translational Models for CNS Drug Discovery

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Section: Measuring Progression and Outcome Measuresmentioning

confidence: 99%

Translational Research in ALS

Montes

Bendotti

Tortarolo

et al. 2008

Animal and Translational Models for CNS Drug Discovery

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“…2 An independent Clinical Research Organization may be employed to monitor the trial. Sites and investigators may be selected by a variety of means, but final approval based on quality of the sites must be given by the Steering Committee.…”

Section: Trial Conductmentioning

confidence: 99%

“…2 Clinical Research Organization (CRO): Any commercial organization with expertise in the monitoring of clinical trials.…”

Section: Definitionsmentioning

confidence: 99%

“…Issues of quality, independence of the investigators, and low publication rates of negative trials have raised levels of concern worldwide among physicians generally; those conducting stroke trials are no exception. [1][2][3] Further concern has been expressed recently about conflict of interest in trial interpretation and writing of guidelines. 4 -6 Publication of trials with low credibility ratings as well as publication bias arising from failure to publish negative trials has been well documented.…”

mentioning

confidence: 99%

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Recommendations for the Relationship Between Sponsors and Investigators in the Design and Conduct of Clinical Stroke Trials

Donnan

Davis

Kaste

2003

Stroke

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Background-As increasing numbers of clinical trials are being conducted worldwide, there has been concern about the relationship between the sponsors and investigators. Both parties need benchmarks or recommendations to act as a reference point when trials are initiated and conducted. These recommendations are designed to fulfill this role. Summary of Comment-A series of meetings of the International Trial Subcommittee of the International Stroke LiaisonCommittee, American Stroke Association, were conducted to review a series of draft recommendations that were then modified on the basis of the experience of the committee in the conduct of clinical trials. Consensus was reached on all points of the final document. The recommendations represent the opinions of the authors and do not necessarily reflect the views of the American Stroke Association. The document contains sensible recommendations concerning required sponsor company qualities, trial management structure, protocol development, trial conduct, data management, blinding, data analyses, publication, remuneration, and conflict of interest issues. Conclusions-The recommendations should provide a simple and practical benchmark for both investigators and sponsors in the conduct of clinical trials. Although designed for trials involving therapies for stroke, the framework allows generalization to other disciplines.

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“…Second, we resolved that we should adopt a similar stance to the neurology journals (3) in regard to reporting clinical trials. Henceforth, Cephalalgia will require the principal author to declare in writing prior to the paper being sent for review that he or she will take full responsibility for the data, the analyses and interpretation, and the conduct of research; that he or she had full access to all the data; and that he or she had the right to publish any and all data, separate from the attitudes of the sponsor.…”

mentioning

confidence: 99%

A Report on the Journal

Goadsby

2003

Cephalalgia

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Reporting clinical trials: full access to all the data

Cited by 3 publications

References 3 publications

Translational Research in ALS

Translational Research in ALS

Recommendations for the Relationship Between Sponsors and Investigators in the Design and Conduct of Clinical Stroke Trials

A Report on the Journal

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