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Center for Global Research Data

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CureDuchenne

About CureDuchenne is recognized as the global leader in research, patient care and innovation for improving and extending the lives of children with Duchenne.
Will individual participant data be available (including data dictionaries)? Yes
What data in particular will be shared? All of the individual participant data collected, after deidentification, for placebo subjects from the phase 2 and 3 randomized, double-blind, placebo-controlled clinical trials of drisapersen for the treatment of Duchenne muscular dystrophy (DMD) as well as observational studies.

The PRO-DMD-01 study was a prospective observational study of disease progression of boys with Duchenne muscular dystrophy.

Exceptions Data sets will not be shared with investigators employed by for-profit commercial entities.

The data sets cannot be used to pursue commercial purposes.

What documents will be available? For clinical trials:

Study data, in a format similar to SDTM

Protocols with all amendments

Annotated case report forms

Dataset specifications (“define” files)

For observation studies:

Raw datasets

Protocol

Operations manual

For what types of analyses? Investigation of placebo response and the outcomes of comparator (placebo) subjects in DMD clinical trials
By what mechanism will the data be made available? Using the Vivli Platform via secure download