NEWS      WELCOME      CONTACT EMN      EMN SO      EMN TRIALS      EMN TRIAL GROUP      EMN BIOLOGY GROUP      LOGIN      MSCNET

 Updated on: Jan 9 2014

Clinical data registration (Minimal Essential Data, MED)

 

Subject
Each national or regional myeloma group has its own data registration system activated during clinical trials. Currently there is no standard minimal data set thus inter-study comparability is hampered.

 

Preview of Programme Proposed
In accordance with EU harmonisation on Good Clinical Practice (GCP) future trial case report forms will fulfill the recommendations. An early aim will be to establish a full set of EUMMNE case report forms (CRF) for;

  • newly diagnosed patients with minimal essential data and follw up
  • active clinical trials
  • previous trials including a demographic database of late effects
  • biobank material

Deliverables and Cooperations
A set of MED sheets to be used for reporting clinical trial data;

  • a clinical Trial Committee composed of individuals from each country, most likely from the Myeloma Groups in order to obtain broad European consensus
  • a central randomisation center for MM trials.

Secr. Hans E. Johnsen | Depart. of Haematology | Aalborg University Hospital | Sdr. Skovvej 15 | DK-9000 Aalborg | Denmark | T:+45 9766 3871 | F:+45 9766 6369