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DeSScipher – To decipher the optimal management of
systemic sclerosis
Grant agreement n° 305495
Start Date: 01/12/2012 - Duration: 36 months
Coordinator: Prof. Ulf Müller-Ladner, JLU Giessen
DESSCIPHER KICK-OFF MEETING
FRANKFURT 22ND OF JANUARY 2013
Minutes of the meeting
Document history
When
Who
Comments
25/01/2013
NOVAMEN
Provided 1 draft
26/01/2012
Coordinators
Provided modifications
28/01/2013
NOVAMEN
Provided amended version to partners for comments
31/01/2013
NOVAMEN
Inserted partner’s comments
01/02/2013
NOVAMEN
Provided final version to the consortium
st
Annotation:
Solution: consensus between all members of the consortium
Action point: mandatory “to do” for the person/team mentioned
KOM, Frankfurt 22nd of January 2013
Minutes of the meeting
DeSScipher
Table of Contents
1. DESCRIPTION OF THE WORK PACKAGES ...................................................... 3
1.1. WP7 - Management .......................................................................................... 3
1.2. WP1 - Database and data analysis ................................................................. 3
1.3. WP3 - Prevention and treatment of severe vital organ manifestations ....... 4
1.4. WP2 - Prevention and treatment of functionally incapacitating
manifestations .................................................................................................. 5
1.5. The juvenile SSc cohort................................................................................... 5
1.6. WP4 - Definition of appropriate measures to evaluate off-label prevention
and treatment of SSc ....................................................................................... 5
1.7. WP5 - Ethics and data monitoring .................................................................. 6
1.8. WP6 - Dissemination and guidelines .............................................................. 7
2. OVERALL DISCUSSION...................................................................................... 7
3. IMPLEMENTATION OF THE PEC (PROJECT ETHICAL COMMITTEE) ............ 8
4. ACTIONS PLAN ................................................................................................... 8
4.1. e-CRF ................................................................................................................ 8
4.2. Ethical certificate ............................................................................................. 9
4.3. PEC.................................................................................................................... 9
4.4. Management ..................................................................................................... 9
4.5. Logo .................................................................................................................. 9
5. ATTENDANCE LIST............................................................................................. 9
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1. DESCRIPTION OF THE WORK PACKAGES
1.1. WP7 - Management
WP leader: JLU Giessen
S. Lacharme-Reichert (NOVAMEN) introduced the consortium to the main aspects of FP7 projects
management.
CA
It was mentioned the fact not all partners have signed the Consortium agreement yet.
Action point: all partners need to sign asap.
SAB
There was a wide discussion about the role of the SAB members and the frequency of SAB meetings.
It was highlighted that SAB meetings usually take place on the occasion of the annual SC meetings.
Pre-financing
C. Veldman from JLU Giessen EU grants office indicated that the pre-financing was just sent from the
EC to JLU Giessen. As soon as it will be validated by JLU Giessen financial department as well as Ulf
and Ingo, JLU Giessen will proceed to the payment of the first installment of the pre-financing
according to the split which was already communicated to all partners.
Guarantee fund
Clarifications about the purpose of the guarantee fund were made: this fund is not aimed at covering
defaulting partners who wouldn’t achieve their work but rather partners who would go bankrupt. The
guarantee fund is implemented by the EC. Provided a successful completion of the project the full
amount of funding including the guarantee fund will be distributed to the consortium.
Reporting requirements
It was then underlined that a partner defaulting in his reporting requirements threatens the whole
project since no payment will be addressed as long as the required reports have not been completed.
In addition every DeSScipher partner institution has its own responsibility towards the EC and in the
worst case scenario the coordinator is entitled to take out a defaulting partner from the consortium.
Action point: Novamen to develop and distribute a reminder reporting plan with reminders at least 8
and 4 weeks prior to EU submission dates.
Timesheets
S. Lacharme-Reichert also focused on the use of timesheets to document the hours spent on the
DeSScipher project. Timesheets are not required for reporting but in case of audits for transparency.
She mentioned that it is not mandatory to claim person months/personnel costs, meaning that one can
choose not to cover his or her salary with the EU-grant as long as the respective organization is fine
with that (depends on internal agreement and might not be the case because of the indirect costs
involved).
1.2. WP1 - Database and data analysis
WP leader: Uni Basel
Uli Walker (FPS) introduced the different features of the database which should be extended and
implemented in the WP1.
Questions and remarks which resulted from the presentation:
- Which criteria connected with the definition of the SSc should be implemented (extension from
MEDSonline)?
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Solution: both old and new ACR/EULAR criteria
- Which inclusion criteria should be used for juvenile patients?
Action point: Ivan Foeldvari to provide criteria
-
Should we include “all” the EUSTAR centers data in the database? (+ ethical questions cf
WP5, since WP5 does not cover EUSTAR centers beyond the DeSScipher partner centers)
Solution: As the MEDSonline data and additional centers are already mentioned in the Desscipher
research program, only the additional EUSTAR centers which will contribute actively do have to fulfill
the same ethics requirements if they join.
-
Real-time connection to the database when the patient is on site would be requested from all
participants
Action point: New Win AG to develop desktop computer and laptop program to enter the data online
while the patient is at the site
- What to fill in when the answer is unknown for a given data item? (yes/no and ???)
Solution: yes, no, unknown
- Enable automatic reminder when some fields are not filled in?
Action point: yes, to be integrated automatically in the program, to be developed by New Win AG.
-
Which data items should be collected for the DeSScipher OTs and how detailed should they
be?
Action point: OT leaders, the FPS team and the JLU team are requested to review and rate the data
items which have been suggested so far using a red/yellow/green ranking system in order to facilitate
the answers to the core questions of the OTs as most important goal.
-
Degree of details about medications can make monitoring difficult: data analysis should be as
smooth and simple as possible
Solution: see above
-
“Sub-studies” suggested by Uli to go further and agreed on by everyone: 1) smoking; 2) ACR
criteria vs. ACR/EULAR criteria
Action point: to be determined by each OT leader
1.3. WP3 - Prevention and treatment of severe vital organ
manifestations
WP leader: Uni Napoli (G. Valentini)
OTs concerned in this WP: OT3/4/5
OT
OT3
Prevention and treatment of ILD
OT4
OT5
Development and prevention of PH
Development and prevention of SHD
PI
G. Riemekasten (Charité), C. Denton (UCL), I.
Foeldvari
Y. Allanore (UPD), I. Foeldvari
G. Valentini (UNINA), I. Foeldvari
In this WP, each task corresponds to an OT. Moreover, each task begins with a retrospective analysis
of already stored data from the MEDSonline database, according to specific criteria to be further used
in each OT.
G. Valentini, Y. Allanore and C. Denton have presented the work which will be developed in their
respective OT.
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1.4. WP2 - Prevention and treatment of functionally incapacitating
manifestations
WP leader: Uni Leeds (F. DelGaldo)
OTs concerned in this WP: OT1/2
OT
OT1
Prevention and treatment of DU
OT2
Improvement of hand dysfunction by arthritis
PI
M. Matucci-Cerinic (UNIFI),
(Leeds), I. Foeldvari
L. Czirjak (PECS), I. Foeldvari
F.
DelGaldo
M. Matucci-Cerinic (on behalf of F. DelGaldo who was unable to attend due to weather conditions)
described the work which will be done in the OT1, and I. Tarner, on behalf of L. Czirjak (who followed
the meeting online), described the work which should be done in OT2.
1.5. The juvenile SSc cohort
Ivan Foeldvari is responsible for the juvenile cohort which is targeted in all OT. From this point of view,
he is taking part in both WP2 and WP3.
Several questions and remarks arose during his presentation:
-
The juvenile cohort does not always have the same endpoints as the adult cohort so that
special criteria in the data analysis should be developed in order to differentiate the two
situations.
Action point: Ivan Foeldvari to determine the parameters together with PRES
-
Even if the patients are regarded as “juvenile” up to the age of 16 years, it would be easier to
extend this sample of patients to the age of 18 years in order to facilitate the consent/assent
form process.
Solution: Patient of ≥18 years of age are considered as adults, patients <18 years of age are
considered juvenile; the date of inclusion counts
-
Weaknesses may appear in the data analysis due to the lack of input
- Consider the cases of young patients who will turn 18 during the OT
Solution: If a patient is below 18 at the time of inclusion and turns 18 during the 3-year period of the
project, he or she will be documented as juvenile until the end of the project
1.6. WP4 - Definition of appropriate measures to evaluate off-label
prevention and treatment of SSc
WP leader: G. Riemekasten (Charité)
Dörte Huscher presented the work package 4 and especially some results of the data already
available from MEDSOnline in order to produce some retrospective analysis.
She stressed the fact that most of the data sets available per patient are incomplete. Therefore it is
necessary to proceed to a close monitoring and feedback of the data entries in order to pay attention
to their completeness and ensure a better analysis.
This point is linked with an issue raised during the WP1 presentation about some blanks present in
patient data sets: when there is no answer, does it mean that the answer was unknown or simply
forgotten? How to fix this point? The upper limit for missing data should not exceed 10 to 20% in order
to allow a correct analysis. In this case multiple imputations could be used to allow a correct analysis.
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Action point: Charité will be in charge of reminding the OT leaders about the blanks in the data sets for
the prospective analysis.
A process has to be defined concerning the blank data for the retrospective analysis
Solution: The secretary of EUSTAR shall get the information from Berlin and contact the PIs of the
concerned trial centers in order to get information back (also about mistakes in the entries).
Concerning the analysis’ criteria, they have to be as close as possible to the disease.
Action point: CHARITE to determine the data, JLU to inform the secretariat about the procedure
Another difficulty could be the number of patients reached per incentive vs. the number of patients
targeted.
Dörte Huscher also asks for a regular data export from the WP1 leader because it is thus easier for
her to validate data.
Action point: WP1 leader to contact CHARITE what they need and when
1.7. WP5 - Ethics and data monitoring
WP leader: O. Distler (UZH)
Concerning the first deliverable, the situation is extremely critical since not all centers have yet
obtained their respective local ethics approvals and the time for achieving this deliverable has already
st
started on December 1 , 2012. No OT can begin before everybody gets those approvals which have
to be delivered by the end of February 2013.
Reminder: Ethic committee approvals for the complete DeSScipher trial program are needed
for all centers. No exception is allowed by the EC. Moreover, for the juvenile cohort, a specific
content has to be submitted. The approvals obtained in the past for EUSTAR MEDSonline and
the VEDOSS projects are not sufficient. A specific ethical approval valid for all Observational
Trials of the DeSScipher project (either as amendment of the existing EUSTAR
MEDSonline/VEDOSS approvals or as a new approval, depending on the rules and
requirements of the local ethics committees) is requested by the EC and needs to be delivered
in time at the end of February as DeSScipher Deliverable 5.5 regardless of what hindered the
process before. If we are not achieving this goal it is likely that funding ends immediately for all
centers.
Retrospective analysis does not need specific approval because it is performed on the existing
MEDSonline data. In contrast, the prospective DeSScipher OTs go will include additional data items.
Below, you find the process proposed by Uni Zürich in order to get your certificate approved:
Flow for ethic committee approvals:
Sites: Send draft ethics documents to CTC UZH ([email protected]; [email protected])
CTC-UZH: Review of the draft documents based on the checklist with EC requirements
CTC-UZH: Informs the sites about the the results of the review, potential mistakes or missing points;
filled checklist is attached
Sites: Revision of ethics documents
Sites: Send revised documents to CTC-UZH for final check
CTC-UZH: Final check and information of sites about fulfilled requirements or additional points to be
corrected
Sites: Additional corrections of documents as necessary or submission of documents to their local
institutional ethics committee (IEC) and notification of CTC-UZH
Sites: Receipt of IEC approval and notification of CTC-UZH including a copy of the IEC approval
If a center which is not a beneficiary of the DeSScipher project wishes to contribute observational
patient data to the DeSScipher study, it will have to follow the same certification process (but these
certification process is independent from the EU deadlines)
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Nevertheless, regarding human resources for the project at the Zurich center, which is responsible for
monitoring of data quality and observation of ethical conduct of the DeSScipher project, it is important
to keep in mind that it would not be possible to audit all the centers. While advice to prepare ethical
committee applications is available to all EUSTAR centers, e.g. on the EUSTAR webpage, WP 5 can
take no responsibility for appropriate ethical approvals of centers outside the consortium. Coordinator
agreed to that statement. Another question will be also to know how to “affiliate” new centers to the
project.
Solution: see above.
Concerning the recruitment of patients: each OT PI is fully responsible for the recruitment of patients
for his or her OT but it is expected that all DeSScipher partner centers contribute patient data to all
OTs.
Concerning task 5.4, the project targets only the incidental findings reporting and not the SUSAR
reporting.
Incidental findings reporting is also a very important point for the EC (cf. ethics review report, ERR,
which has been provided to all DeSScipher partners), thus it is crucial to follow all quality processes
very carefully.
Specific questions:
1) Check whether all centers can include juvenile SSc patients, probably no because not
specifically mentioned in ethics?
Answer: Juvenile patients can only be included into Desscipher when your ethic application and
informed consent is specifically mentioning them. Thus, most of the direct Desscipher centers cannot
enter juvenile patients at the moment except Hamburg after it gets its ethic approval. If other direct
Desscipher centers want to include juveniles, ethics have to be amended.
2) Check whether a patient who is in an interventional trial can be included “observational” into
Desscipher in particular if the interventional study has the same study drugs as the
observational study.
Answer: There is no clear argument against including these patients from an ethical point of view.
Scientifically it is questionable, as these patients in clinical trials behave differently than clinical
practice observational patients.
3) Juveniles who are turning 18 have to sign a new adult consent form for ethics?
Answer: Again, this is “grey zone”. The Zurich ethic team strongly recommends to get an additional
signature from the then adult patient at the next visit after she/he turned 18.
1.8. WP6 - Dissemination and guidelines
Owing to shortage of time and participants at the end of the meeting, this discussion has been
postponed.
Action point: this will be done and organized by Giessen/FESCA/Novamen. The first important step is
the implementation of an internal and a public DeSScipher webpage.
2. OVERALL DISCUSSION
Targeted number of patients per OT: should the targeted number of patients be reduced according to
even more precise criteria?
Solution/action point: each OT leader must calculate the biostatistics to be able to answer the
research questions and disseminate these data to all members. JLU Giessen (see 1.8.) will develop
monthly updates on recruitment rates and disseminate those to all members in due time, UZH needs
to collect data from OT leaders and send the package to JLU Giessen.
Is it possible to include more EUSTAR centers in the project, how to include them? What about the
consequences for UZH in term of data audit and data management?
Solution: See above, and we do still have the option to do selected data quality checks with these
centers (just that they know somebody could be coming).
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3. IMPLEMENTATION OF THE PEC (PROJECT ETHICAL
COMMITTEE)
The PEC has been implemented (Composition: Karin HUBER – Uni Hospital Zürich, R.
VOSWINCKEL – Uni Giessen, E. RIAL-SEBBAG – INSERM).
UZH asks for a work guideline. A telephone conference should be organized soon between the PEC
members and the management team so that the PEC members get to know each other, to develop a
common working plan and to agree on how to exchange with the consortium.
Communication flow: On a regular basis, OT leaders and WP leaders will send information on the
progress of the work and/or specific ethical requests to the management team which will liaise with the
PEC.
Action point: Novamen to organize the TC and bring PEC members together, report to Giessen, then
distribution to all members.
4. ACTIONS PLAN
4.1. e-CRF
-
Each OT PI has to decide which items should appear in the database. This concerns:
o
o
o
o
o
o
For OT1: M. Matucci-Cerinic, F. Del Galdo
For OT2: L. Czirjak
For OT3: G. Riemekasten, C. Denton
For OT4: Y. Allanore
For OT5: G. Valentini
And transversally to all OT: Ivan Foeldvari for the juvenile cohort
A TC will be planned during week 5. Below, as reminder the email from Ingo describing the tasks that
ALL OT leaders should comply with before this teleconference:
“We have identified the need to critically review the data items which have been suggested to Uli
Walker and his group by the individual OT leaders. It is of vital importance to the success of the
DeSScipher project that we collect the right data items. That means on the one hand that we must not
leave out anything in order to be able to answer our research questions. On the other hand there was
consensus yesterday (22.01.13) that we should not aim to collect too many data items because
DeSScipher is an observational project and we may end up with too many missing data points if the
data items which we want to collect are not likely to be indeed applied in clinical routine at the
participating centers.
Therefore, Uli will send out an Excel file to the OT leaders containing all the data items that were
suggested to him for the OTs so far. All of us are hereby asked to critically review all of these data
items with review to importance and feasibility until the evening of Monday, January 28.
Please rate each data item by importance and mark it in a traffic-light type color scheme as
(i) indispensable (red),
(ii) important but debatable (yellow),
(iii) not necessary (green) and send back your thus revised version to Uli.
Uli's team will then prepare a merged list from our suggestions on Tuesday, January 29, and send the
merged list back to us for a brief second round of review. We will then decide on the final list during a
telephone conference which has to be held on either January 30, or January 31 or February 1. I will
prepare a doodle to identify the most suitable time for this TC.”
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NOVAMEN is in charge of the organization of the TC.
Until January 26, 6:00 p.m. the following partners have responded to the Doodle: Uli Walker,
Francesco del Galdo, Laszlo Czirjak, Marco Matucci-Cerinic, Ulf-Müller-Ladner, Marc Frerix and Chris
Denton. Responses are missing from: Yannick Allanore, Gabriele Valentini, Ivan Foeldvari and Gabi
Riemekasten.
Moreover, as said during the meeting, Zurich needs to be involved in this process, as eCRFs need to
be checked for monitoring practicability.
4.2. Ethical certificate
Status of the ethical certificate on the 31.01.13
JLU Giessen – Ulf Müller-Ladner /Ingo Tarner
UZH – Oliver Distler
UPD – Yannick Allanore
UNIFI – Marco Matucci-Cerinic
UNINA2- Gabriele Valentini
UNIBAS – Uli Walker
UCL – Christopher Denton
Charité – Gabriela Riemekasten
PECS – Laszlo Czirjak
LEEDS – Francesco Del Galdo
Juvenile Cohort – Ivan Foeldvari
OK (minor changes re-submitted)
OK (minor changes re-submitted)
Submitted to the ethical committee
To submit asap for review to the ethical committee
OK
OK
To submit asap for review to the ethical committee
To submit asap after JLU Giessen receives approval
OK
To submit asap after UCL receives approval
Submitted to the ethical committee
The “yellow” partners have to follow up on the status of the application process in order to get
their certificate approved as soon as possible.
The “red” partners have to submit their documentation to their local/national ethical committee
immediately according to the procedure described in §1.7. They are recommended to use the
wording of their respective national fellow centers to expedite the process.
No work can begin without the collection of the ethical certificate from all partners
concerned.
4.3. PEC
Organization of a SC. NOVAMEN is in charge of the organization.
4.4. Management
Financial table to send to all partners in order to inform them which amount of money they will
receive and when (week 5)
Sample time sheet to be distributed as excel file to all partners (week 5)
Contact UZH to better understand the situation with the personnel costs
4.5. Logo
Together with Beata Garay-Tóth, 3 very different logos were preselected. They will be sent to all
partners for voting. Each partner has one vote, and the logo receiving most votes will be selected.
Novamen will take the poll.
Update on the 31.01.13: the logo 1 (Sunflower) has been chosen.
5. ATTENDANCE LIST
Laszlo Czirjak couldn’t attend the meeting due to the weather conditions. He participated via Skype
and e-mail exchange.
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