Upload
mitocon-onlus
View
250
Download
1
Tags:
Embed Size (px)
Citation preview
Global (coordination) of MitoPatients Registry: a challenge
5th Italian MeetingMitochondrial Medicine
June 5th 2015 – Bologna
Piero Santantonio
Summary1. Mitocon is involved in Patients clinical Registry projects since 2011
(Italian Network)
2. In yearly meetings IMP, the International Federation of Patients Associations (until now 12 national patients associations from Europe, America, Australia and Asia) for the last 2 years patients registries issue was always present in agenda and the subject discussed
3. In many part of the world researchers and patients associations are working on different registries for two main purpose:• clinical registries• patients driven registries for «counting» mito-patients popolation
and gather informations about state of thier health and quality of their life,.
4. IMP decided in the last meeting in Tampere in june 2014 to start a project titled: Global (coordination of) patient registries
Use of Mito-Patients data
Lobby
Clinical trial
Pharma needs
Social needs
(assoc.)Fund
RaisingPolitical and
Public Health
ClinicalRegistries
Other National/
Global Rare disease
registries
PatientsRegistries
Mito-Patients data: a possible path
Universe of Mito-patients data
Anagr.
basic
specific
(family, country, social
context, ...)
Clinical
symptons
rough
detaile
d
diagnosys
clinical
rough
det.
biochemical
rough
det.
genetics
rough
det.
Bio bank
rough
det.
therapy
rough
det.
follow up
rough
det.
QoL
rough
det.
Social needs
rough
det.
Data needed in Clinical Registries
Universe of Mito-patients data
Anagr.
basic
specific
(family,
territ.
context, ...)
Clinical
symptons
rough
detaile
d
diagnosys
clinical
rough
det.
biochemical
rough
det.
genetics
rough
det.
Bio bank
rough
det.
therapy
rough
det.
follow up
rough
det.
QoL
rough
det.
Social needs
rough
det.
Data needed in Patients Registries
Universe of Mito-patients data
Anagr.
basic
specific
(family,
territ.
context, ...)
Clinical
symptons
rough
detaile
d
diagnosys
clinical
rough
det.
biochemical
rough
det.
genetics
rough
det.
Bio bank
rough
det.
therapy
rough
det.
follow up
rough
det.
QoL
rough
det.
Social needs
rough
det.
Nowadays situation
ClinicalRegistries
Other National/ Global Rare
disease registries
PatientsRegistries
QoLProj.
A possible approach to build a patients registry coherent with other registries
ClinicalReg. #1Data Set
ClinicalReg. #2
Data Set
Patient Reg. #1 Data Set
1. collect data set from active Registries (clinical, patients, «Global»,
2. Involve the main actors:• Patients Ass. because
of QoL and Social needs data
• Clinicians because of clinical data
3. find a possible recomanded data set for Mito Patients (RED) and Clinical Registries (YELLOW)
Recomandeddata set for
ClinicalRegistries
Recom. Data Set for
Patients Reg.
Where we areNation Resp. Data
Type driven by N° of patients
Biobank linked
Germany T. Klopstock Clinical/ Research German consortium 1.000
Yes(~ 90% pts )
UK R. Mc Farland
Clinical/ Research MRC/ Newcastle 1.100
Yes(~ 50%pts)
USA M. Hirano Clinical/ Research Columbia Univ. 500 Yes
USA P. Yeske Patients UMDF500~400
caregiver
~ 100 family
-
USA Amy Holbert Research Rare Diseases C.R.N.
NAMDC 1159 No
Italy M Mancuso Clinical/ Research MITOCON 1.300 Not directly
What we have planned to do• Compare database• Map the data correspondences• Give a sort of minimum standard of patients
registries database• Search for a system or a SW to merge/compare
data• Build a patients-driven Registry for patients
associations purpose, above all with extended QoL data
Where are we?1. review and compare clinical part of the data set
(almost concluded)2. define Patients data set (almost concluded,
Scientific comitee supervision requested)3. review already existing SW which can manage such
patients defined data (ongoing)4. define policy and rules of use of data and
involvement of national associations (to be done)5. define a budget (to be done)6. Plan the following steps (to be done in next IMP
meeting)
Further implementation forItalian Patients Registry1. Mitocon will support the «maintenance» of the
actual Italian Registry• fund for each new patients registration• fund for new Mito-Italian-Centre• fund for research projects (i.e. pediatrics data analysis)
2. Start with Patients Section and Patients inclusion in Patients Registry Project• New QoL section for patients• Call for patients collaboration for personal and QoL
data (NO CLINICAL)