statutes of the eortc brain tumour group
Revision october 2007
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1. Aims of the group
The primary aims of the Brain Tumor Group (BTG) are to conduct, develop, coordinate
and stimulate research on primary and secondary brain tumours. To fulfill these
aims, the BTG will promote and conduct prospective clinical studies, and whenever
possible carry out associated translational research.
The EORTC Brain Tumor Group (BTG) is a multi-disciplinary group within
the European Organisation for Research and Treatment of Cancer (EORTC).
Individuals from EORTC member institutions may apply for EORTC BTG
membership. There is no limit to the number of individuals allowed
as BTG members from the same centre, but a primary contact person
should be designated for each centre and the existence of a valid
e-mail address is mandatory (all regular communications will be done
The BTG recognizes the following membership categories, depending on
the participation in previous trials and the number of patients per
year entered into BTG trials or on the scientific contribution to the
work of the group:
- active: to quality for the active membership it is required to
either include > 4 evaluable patients/year/centre
* or to provide major scientific contribution to the clinical studies
of the BTG (translational research, pathology review, imaging protocols
etc). Members in this latter category are designated by the Steering
- probationary: new members receive the status of probationary member
for an observational period of 2 years. During this period, at least
4 evaluable patients per year per centre have to be entered in BTG
trials, with timely and adequate submission of case report forms.
* The numbers of patients required for active membership may be adapted
by the BTG Steering Committee based on availability of active trials
in a given year.
Requirements, duties and rights of BTG members:
Members are expected to participate regularly in the bi-annual meetings
of the group. In case of non-participation, they may be excused for
a maximum of 2 consecutive meetings.
Only active and probationary members are allowed to enroll patients
in BTG trials. Patient accrual is restricted to those members
fulfilling quality assurance conditions and complying with regulatory
Members need to provide a valid e-mail contact address, and are required
to reply in a timely manner to e-mail requests.
All group members are responsible for their own expenses when attending
bi-annual group meetings.
Active members must adhere to quality assurance review procedures,
which may include formal site visits. For active membership, a recruitment
of at least 4 evaluable patients per year for two consecutive years
is required. An evaluable patient implies fulfilling all the administrative
responsibilities with adequate and timely follow-up as judged by the
EORTC Data Centre.
Active members have the right to vote in elections of the officers
of the group.
Any individual who has expressed the wish to join the BTG and who agrees
to comply with the rules of the group may apply for probationary membership.
A new probationary member is admitted to the group for 2 years. Based
on the accrual during these 2 years, they may become active members.
Probationary members, after undergoing initial quality assurance clearance
may activate BTG protocols and actively enroll patients. The probationary
membership-status can be prolonged or discontinued after that period
based on review by the BTG Steering Committee.
Those wishing to join the EORTC Brain Tumour Group must apply directly
to the EORTC (firstname.lastname@example.org)
after which they will be provided with the procedure to be followed
and the necessary forms for completion.
The EORTC Membership secretariat will evaluate the applicant’s
activity in other EORTC groups, will evaluate the EORTC membership
status of other groups within the center, may request additional information
and documentation as appropriate (e.g. CVs normal laboratory values
and accreditation, etc.), verify that the ROG Facility Questionnaire
has been submitted (in the case of the applicant’s wish to enter
studies with radiation therapy or request its submission) and will
request preliminary approval by the BTG officers. All applications
will be regularly reviewed by the Steering Committee, at least at the
half-yearly meetings, for final approval. If the application
is accepted, the applicant becomes a probationary member and may initiate
participation in trials.
Applicants from an “EORTC Core Institution” (NOCI) or an
EORTC Affiliated Institution are automatically accepted as probationary
The election of
the chair will be held every three years. Active
members of the group have the right to vote in the election of group
officers; if there is more than one member from a single institution
that institution has one vote. Candidates for election may be
proposed by all active member institutions. Voting will take
place at the general assembly or by e-ballot. In case there is
no general consensus or clear two-third majority in favour of a proposed
candidate, a written election may be organized.
Only active members can become officers. The secretary and treasurer
are co-opted while the chairman is elected by the active members.
Prior to the elections the membership list is updated according to
4. Group Officers
The chairman He/she chairs the
steering committee meeting and the plenary business meeting. He/she
represents the group at the EORTC General Assembly/Chairmen’s
The vice chairman replaces the
chairman in case of absence.
The chair-elect will work alongside
the sitting Chair until the end of his/her term
of office and will be a member of the Executive.
The past chairman is
responsible for assistance to the chairman and may represent the chairman
at the EORTC General Assembly/Chairmen’s
Meeting and other EORTC meetings. He/she remains a member of the steering
committee meeting and the plenary meeting to assure continuity of ongoing
and closed projects and studies.
The secretary He/she is responsible
for the organization of the twice yearly meetings and the distribution
of the minutes to the whole group membership. He/she may represent
the chairman at the EORTC General Assembly/Chairmen’s Meeting
and other EORTC meetings.
The secretary and chairman are responsible for coordination between
all members of the group and between the BTG and other cooperative
groups within and outside the EORTC. They are responsible for providing
a yearly report on the activities of the group for the EORTC Central
The treasurer He/she is responsible
for the group finances. The treasurer is responsible for presenting
a report on the group’s financial
situation during the plenary meeting
Term of Office
The chairman, vice chairman and secretary are elected for a term of
three years. In principle a re-election for a second term is only
possible in the case of the secretary. The chairman is elected for
one term only, and re-election is only possible in exceptional circumstances
and with approval of the EORTC Executive Committee. All others are
elected or co-opted.
A new Chair will be elected 18 months before the end of the term of
office of the sitting Chair, becoming the Chair-elect. At the
end of the sitting Chair’s term of office, the Chair-elect takes
the chair and the sitting Chair becomes the Past Chair. The term of
the chair and the other group officers coincide with the term of the
general EORTC Board elections.
5. Group Meetings
meetings are organized twice yearly. A group meeting consists of
a steering committee meeting, a plenary meeting and various subcommittee
meetings, as appropriate. An agenda for the group meetings will be
prepared and posted on the group’s website at least 2 weeks
prior to the meeting and all members will be notified by e-mail of
this. Any active member can request (in writing) additional topics
to be added to the agenda.
All active and probationary members and EORTC Data Centre representatives
are admitted to the BTG plenary meeting. Visitors (i.e. non-EORTC),
representatives of the pharmaceutical industry and members of other
EORTC groups or other cooperative groups may be granted permission
to participate by the chairman or secretary of the group. Parts of
the meeting may be declared as a closed session limited to active and
probationary members only.
In a year in which an EGAM (EORTC Groups Annual Meeting) is organized,
the BTG meeting is incorporated in this event.
Additional meetings can
be organized to address specific strategic or scientific issues.
EORTC BTG has a steering committee which consists of the past and
present chairman, the secretary, the vice chairman, the treasurer
and the chairs of the following subcommittees: Quality Assurance
(QA), Pathology (PA), Translational Research (TR). Further, all coordinators/study
chairs of active trials are automatically also included in the Steering
Committee. The EORTC Data Centre is represented by the Coordinating
Physician, the Statistician, and the Data Manager(s). Further, the
chair of the Brain Tumour Working Party of the Radiation Oncology
Group is part of the Steering Committee. The Steering Committee includes
a designated young scientist (<40 years). On an ad hoc basis,
representatives of other partner groups (i.e. the NCI-C, TROG, RTOG,
other EORTC groups) may be asked to join the Steering Committee.
The Steering Committee will meet prior to the BTG plenary meeting.
At the Steering Committee meeting future strategies and practical matters
will be discussed. The plenary meeting is prepared during the Steering
Committee meeting. All decisions proposed in the Steering Committee
require approval of by the active members during the plenary meeting.
The participation of Officers and Chairs of the Subcommittees in the
semi-annual meetings is considered mandatory. In case of non-attendance
due to conflicting engagements, officers should excuse themselves in
advance, while subcommittee chairs should seek replacement by another
member of the subcommittee. Members of the subcommittees are co-opted
by the Steering Committee.
b. The Quality Assurance (QA) Subcommittee: reviews the performance
of the different centres participating in the group trials. The members
of this committee should reflect the different fields of specialty
involved in the treatment of brain tumors (at least a radiotherapist
and a medical oncologist). They meet at least once a year. They review
the memberships and the compliance with regulations. They will set
up a system of quality assurance for the group trials.
c. The Pathology (PA) Subcommittee gives guidelines for pathology
review within trials, and assists in the development of translational
d. TheTranslational Research (TR) Subcommittee will
advice the BTG / EORTC Protocol Review Committee regarding proposals
e. A Nominating Committee is an ad hoc committee which is
convened at the time of election of group officers to receive the names
of candidates for the positions to be filled.
7. Publications and authorship
All publications of group studies, oral
and written, will have “EORTC
Brain Tumor Group” in their title and must be approved by the
chairman or the secretary, the involved statistician and the study
coordinator. Authorship includes:
- the study coordinator (usually the first author)
- representative(s) of the centres which have contributed 10% or
more of the cases included in the publication are always co-authors
- members who have included less than 10% of patients will be included
as co-authors at the discretion of the study coordinator, based on
the contributions to the trial (e.g. design, associated research,
- at most two representatives of the EORTC Data Centre
- Authorship may have to be shortened in cases of limitations in
the number of authors imposed by the journal, which may overrule
the above described regulations.
- All other investigators and sponsor representatives must be acknowledged.
All manuscripts and abstracts must be sent for review by all co-authors
prior to submission for publication; the co-authors must send their
opinions within 3 weeks. All accepted abstracts and publications must
be sent to all co-authors, to the secretary of the group and to the
8. The development and writing of a new protocol
New protocols or their outline should be presented and discussed in
the plenary meeting. In cases where rapid protocol development is
indicated, the outline can be approved by the Group officers, allowing
submission to the EORTC Executive Committee for further feasibility
review before Protocol Review Committee (PRC) review and full protocol
development. All trial proposals are developed according to EORTC
regulations, and require approval of the EORTC Executive Committee.
Further development of the protocol requires the involvement of the
Data Centre Staff and require approval of the PRC. It is mandatory
that the TR subcommittee approves and is involved early on in the development
process. A representative of the TR and PA subcommittees
should be part of the protocol writing committee.
The formulation of a budget and negotiations with a potential sponsor
will be undertaken by the Principle investigator in collaboration with
the Group Chair, Secretary and Treasurer, together with representatives
of the EORTC Data Centre.
Translational research (TR)
Translational research and correlative studies are a particular focus
of the EORTC BTG. The BTG strives for integration of ancillary studies
within most clinical protocols. The study coordinator and the Translational
Research Committee coordinate, in close collaboration with the Pathology
Committee, all translational research, with advice from the EORTC TRAC
(TR Advisory Committee) where appropriate.
TR projects must be approved by the principal investigator (PI) of
the study which is involved in the project, the TR Subcommittee and
the chairman and the secretary of the BTG. If translational research
has not been foreseen in the initial protocol, or when stipulated by
the protocol, review and approval by the EORTC Protocol Review Committee
may be required.
All new initiatives within the BTG should be submitted to the TR Subcommittee
for review, comment and consideration of biological studies prior to
full development of the protocol.
Principle investigators (PI)
PIs are appointed by the group and hold office for the duration of
a protocol. The person bringing forward the protocol idea, developing
the outline and mobilizing appropriate funding is usually the study
coordinator. He/she should actively take part in the study. With
help of the Data Centre they are responsible for the good running
of the protocol, and for resolving any difficulties which may arise
during the study. They are encouraged to have personal contact with
local investigators in order to assure a smooth and problem-free
accrual. They are responsible for the preparation of appropriate
publication material, and for obtaining agreement of all concerned
authors. Principle investigators should be involved in budgeting
of a new study, i.e. to include in Data Centre calculations any amounts
which will be needed, i.e. for QA or TR so that these are not overlooked.
9. Quality assurance (QA)
The Quality Assurance Subcommittee develops quality assurance criteria
for protocol treatments. The chairman of this subcommittee is chosen
by the Steering Committee and represents subcommittee in the Steering
Committee. All active and probationary members of the BTG are expected
to comply with the minimum requirements for participation in BTG
studies. For joint studies with the Radiation Oncology Group,
they also need to comply with the ROG-specific quality assurance
10. Clinical Trial Data
Data will not be
released from the Data Centre without the permission of the study coordinator
and the chairman of the group. Data of the complete trial may not be
used in oral or written form without the permission of the principle
investigator. Trial results of individual centres may not be presented
in oral or written form before the results of the entire study are
published. The first presentation of results of a BTG study will take
place at the BTG plenary meeting. Exceptions
to this rule (in the case of advance preparation of abstracts for international
meetings) will be decided by the chairman and the secretary of the
Any data transfer to a pharmaceutical industry or to other (academic)
investigators must be approved by the chairman, the study coordinator
and the Director of the Data Centre.
The chairman, secretary and
the treasurer are responsible for the finances of the group.
The group has several sources of income:
- Sponsor funding by pharmaceutical companies for trials of the group.
- Grants arising from project applications to funding bodies, e.g.
EU Framework Program, national cancer leagues
- Other sources (eg. donations from charitable organizations)
All funds are handled centrally by the EORTC Accountant, expenses
require review and authorization by the BTG Treasurer. The chair of
the group will authorize expenses of the treasurer.
The group will pay expenses per trial and per randomized eligible patient,
based on an approved budget, for which often earmarked income and been
secured (eligibility to be evaluated by the Data Centre/PI). Other
expenses require formal approval by the Steering Committee and/or the
Group Plenary session. The following expenses are usually considered
by the BTG:
- secretarial expenses for the chairman, secretary and treasurer
- reimbursement of costs of centres in particular trials (per evaluable
patient), usually paid at the end of the trial. Interim payments
can be performed based on evaluable patients on written request of
- reimbursement of expenses in connection with quality control activities
or review of data at participating centres by members of the group
- reimbursement of the cost of study coordinators’ visits to
the Data Centre and other activities related to the study conduct
(e.g. representation at other groups’ meetings)
- reimbursement of travel expenses of group members who are requested
to represent the BTG at other meetings
- reimbursement of travel expenses of non-members who are invited
to group meetings
- reimbursement of expenses of Fellows allocated to specific projects
of the group
- cost of publication (e.g. per page costs in certain journals, colour
printing of illustrations)
In addition, the group may want to support unfunded or insufficiently
funded studies with a grant to the EORTC Data Centre, or to investigators
performing ancillary and translational research; decisions on this
matter to be taken by the Steering Committee.
Payments up to € 5.000 can be authorized by the group chair or
the group secretary, payments between € 5.000 and € 25.000
require authorisation by both the group chair and the group secretary,
payments in excess of € 25.000 require authorization by the group
chair and at least two of the other three group officers (Secretary,
Vice Chair, Treasurer).
12. Revision of statutes
The statutes may be revised at any time by the group officers. Although
changes can come into effect immediately, they require the approval
by the active members of the group at the next following general assembly.