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Sharing data from MS clinical trials: Opportunities, challenges, and future directions.

Coetzee T - Mult. Scler. (2015)

Bottom Line: The treatment of people affected by multiple sclerosis, particularly the relapsing forms of the disease, has been transformed by the availability of various therapeutic agents.This landmark progress is due to an enormous foundation of clinical research and, particularly, numerous phase II and III clinical trials.Although the research community has many reasons to take pride in this progress, a fundamental question remains about whether opportunities for additional research are being lost due to inadequate clinical trial data sharing.

View Article: PubMed Central - PubMed

Affiliation: National Multiple Sclerosis Society USA, New York, USA timothy.coetzee@nmss.org.

No MeSH data available.


Related in: MedlinePlus

Clinical trial life cycle: when to share data.Schematic showing a time line of the clinical trial life cycle and the major milestones (numbered 1–5). The downward pointing arrows show times during the clinical trial life cycle at which trial data could be shared. This figure is reproduced with permission.http://www.iom.edu/~/media/Files/Report%20Files/2015/SharingData/DataSharingKeyFigures.pdf.
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fig1-1352458515608005: Clinical trial life cycle: when to share data.Schematic showing a time line of the clinical trial life cycle and the major milestones (numbered 1–5). The downward pointing arrows show times during the clinical trial life cycle at which trial data could be shared. This figure is reproduced with permission.http://www.iom.edu/~/media/Files/Report%20Files/2015/SharingData/DataSharingKeyFigures.pdf.

Mentions: The United States Institute of Medicine (IOM) recently released a report entitled “Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk” (http://www.iom.edu/Reports/2015/Sharing-Clinical-Trial-Data.aspx). The report, which was sponsored by a diverse group of stakeholders including government funding agencies, regulators, foundations, and pharmaceutical and medical device manufacturers, was produced by an expert committee (including the author) with the goal of fostering a culture of clinical trial data sharing that will increase scientific knowledge and ultimately improve therapies. The committee recognized that there are several stages in the clinical trial cycle at which data can be shared (Figure 1) and made four main recommendations for responsible sharing of clinical trial data (Table 1).


Sharing data from MS clinical trials: Opportunities, challenges, and future directions.

Coetzee T - Mult. Scler. (2015)

Clinical trial life cycle: when to share data.Schematic showing a time line of the clinical trial life cycle and the major milestones (numbered 1–5). The downward pointing arrows show times during the clinical trial life cycle at which trial data could be shared. This figure is reproduced with permission.http://www.iom.edu/~/media/Files/Report%20Files/2015/SharingData/DataSharingKeyFigures.pdf.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2 - License 3
Show All Figures
getmorefigures.php?uid=PMC4594087&req=5

fig1-1352458515608005: Clinical trial life cycle: when to share data.Schematic showing a time line of the clinical trial life cycle and the major milestones (numbered 1–5). The downward pointing arrows show times during the clinical trial life cycle at which trial data could be shared. This figure is reproduced with permission.http://www.iom.edu/~/media/Files/Report%20Files/2015/SharingData/DataSharingKeyFigures.pdf.
Mentions: The United States Institute of Medicine (IOM) recently released a report entitled “Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk” (http://www.iom.edu/Reports/2015/Sharing-Clinical-Trial-Data.aspx). The report, which was sponsored by a diverse group of stakeholders including government funding agencies, regulators, foundations, and pharmaceutical and medical device manufacturers, was produced by an expert committee (including the author) with the goal of fostering a culture of clinical trial data sharing that will increase scientific knowledge and ultimately improve therapies. The committee recognized that there are several stages in the clinical trial cycle at which data can be shared (Figure 1) and made four main recommendations for responsible sharing of clinical trial data (Table 1).

Bottom Line: The treatment of people affected by multiple sclerosis, particularly the relapsing forms of the disease, has been transformed by the availability of various therapeutic agents.This landmark progress is due to an enormous foundation of clinical research and, particularly, numerous phase II and III clinical trials.Although the research community has many reasons to take pride in this progress, a fundamental question remains about whether opportunities for additional research are being lost due to inadequate clinical trial data sharing.

View Article: PubMed Central - PubMed

Affiliation: National Multiple Sclerosis Society USA, New York, USA timothy.coetzee@nmss.org.

No MeSH data available.


Related in: MedlinePlus