Lily Chu looks at Sharing Clinical Trial Data: Recommendations from IOM and ICJME

[Dolphin]

Full title: Sharing Clinical Trial Data: Recommendations from the US Institute of Medicine (IOM)
and the International Committee of Medical Journal Editors (ICJME) – Lily Chu, MD

From: IACFS/ME MAY 2016 NEWSLETTER

Study Data Transparency and Sharing: For ME/CFS, concerns over the PACE trials are pushing the call for data transparency and sharing to the forefront. However, this is an issue that has been brewing for some time within the scientific and medical world and will have consequences for all stakeholders in the future. Lily Chu takes a wide-angle-lens look at the issue, drawing on recent recommendations from the US Institutes of Medicine and the International Committee of Medical Journal Editors. Read more:
http://iacfsme.org/PDFS/2016MayNesletter/Attachment-07-Dr-Lily-Chu-Sharing-Clinical-Trial-D.aspx

 

[BurnA]

From: IACFS/ME MAY 2016 NEWSLETTER

Interestingly, the Lancet, which is a member of ICJME and published the PACE trial has not
supported or been open to calls from patients, clinicians, and scientists to re-evaluate the PACE
trial or for external investigators to obtain de-identified patient-level data. This is also despite the
PACE trial authors reporting only part of their pre-specified outcomes without reporting why
other outcomes were dropped. In contrast, PLOS Medicine, also an ICJME member, which
published another paper related to the PACE trials, are taking these concerns seriously and their
staff is following up on this matter. Time will tell; look for our 3rd installment of this continuing
saga in a future Newsletter.

 

[Esther12]

Thanks to Lily Chu... hoping there will be some good news on this before part III comes out!

 

[JohnCB]

4) Responsible data-sharing is not under the authority of any one entity but shared
among different stakeholders. What can different groups do to promote responsible
data sharing? Some examples out of many in the report:
...
e. Disease advocacy organizations – “provide guidance and educational programs on
data sharing for clinical trial participants”

Is this something that is within the scope of PR?

Should we be providing guidance for participants in research studies? It's too late for PACE obviously, but there is still Magenta and stuff.