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EORTC AISBL / IVZW |
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EORTC AISBL / IVZW |
All protocols conducted by EORTC need to be approved by an independent panel of experts. This independent peer review process has been implemented by EORTC as early as 1983: the Protocol Review Committee (PRC) appointed by the EORTC Board reviews all projects proposed by EORTC Groups.
For a study to be conducted under the EORTC label, EORTC experts have to have an impact on the study design and the project has to be approved by the PRC. In addition, the database should be handled by the Headquarters (HQ) staff and the final analysis should be performed by an EORTC statistician unless conducted by another independent research group in the context of a so-called intergroup clinical trial.
The PRC comprises experts in the field of cancer clinical research. All disciplines of oncology are represented in the review panel. About 50% of the PRC members are non-EORTC, which also includes a representative of the US National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP). Additionally, the PRC makes systematic use of external reviewers – a minimum of three and a maximum of five international experts are consulted for each outline, thereby providing independent review.
The function of the EORTC PRC is to assess the compliance of studies proposed by EORTC Groups with the EORTC scientific strategy, and to assess their scientific value in terms of originality, interest, methodology and scientific feasibility. The PRC assists the groups whenever necessary concerning any aspect of the design and implementation of their studies from the first outline proposal to the full protocol.
Protocol outlines are submitted to the PRC Secretariat via the Internet using a supplementation and maturation of the information provided in the Early Project Optimization Department (EPOD) form.
The outline submission questionnaire is available from the EORTC website: www.eortc.be. Once final, an outline is submitted to the PRC. This can only be done after an initial feasibility go-ahead.
About 50% of the submitted protocols are joint protocols with non-EORTC Groups (e.g. MRC-CTU, FNCLCC, GIMEMA, NCIC-CTG) and of these approximately 60% are coordinated by the EORTC.
The review of intergroup studies depends on whether the EORTC is the coordinating group or joins a protocol which will be run by another Group’s data centre.
Outlines may be approved at the time of review or more often only approved after revision, and others are rejected. Most protocol outlines are resubmitted after detailed comments from the PRC and could still at that time be reviewed by external experts of the particular field involved.
Outlines approved by the PRC may be subsequently developed as full protocols once feasibility has been confirmed and if the budget needed to manage the study is fully covered. If this budget is not fully covered, they are subsequently submitted to a competitive selection process carried out by the EORTC Board. The Board will decide to allocate EORTC funding (from the EORTC Academic Fund) on the basis of the scientific evaluation provided by the PRC.
In order to simplify the writing of the full protocol, but also to guarantee homogeneity of protocols and compliance to EORTC policies, the PRC in conjunction with the EORTC Protocol Help Desk have developed a set of core documents and templates available to the EORTC HQ teams and Groups. The PRC approved documents include guidelines to improve the content/clarity of all protocols; guidelines developed for the writing of each of the chapters and appendices of a protocol and standard versions for various administrative chapters (for example insurance, ethical consideration, reporting serious adverse event and randomisation).
The Protocol Development Unit (PDU) follows the overall protocol development and approval process. Full protocols must be a faithful development of approved outlines. Significant modifications of the study outline after its approval will need to be approved again by the PRC. If the modifications have an impact on the resources to be allocated by the EORTC, the decision of the EORTC Board to have the study supported by the EORTC may be reconsidered. After a protocol is approved and released any change is deemed an amendment. The PRC approves scientific amendments to EORTC protocols and the PDU coordinates their implementation into protocols.
All efforts are made to speed up the review process to meet the wish of groups to get protocols activated quickly but there is an absolute necessity for the PRC to make sure that all studies with the EORTC label are carried out according to the highest possible standards (scientific, administrative and regulatory) of clinical scientific investigation. The New Drug Advisory Committee (NDAC), the Translational Research Advisory Committee (TRAC) and the Elderly Taskforce (TFE) provide additional scientific expertise when needed.
Members & Ex-Officio Members
Chair F.A. Shepherd, Toronto (CA)
Vice-Chair M. Eriksson, Lund (SE)
J.-P. Armand, Toulouse (FR)
J. Bernier, Genolier (CH)
S. Bodis, Aarau (CH)
K. Conlon, Dublin (IE)
A. Craft, Newcastle (UK)
T. de Witte, Nijmegen (NL)
V. Diéras, Paris (FR)
C. Dittrich, Vienna (AT)
F. Guillemin, Vandoeuvre les Nancy (FR)
C. Hill, Villejuif (FR)
N. Isambert, Dijon (FR)
E. Jäger, Frankfurt (DE)
O.S. Nielsen, Aarhus (DK)
J. Oliveira, Lisboa (PT)
M. Parmar, London (UK)
R. Rosell, Badalona (ES)
A. Sobrero, Genova (IT)
G. Velikova, Leeds (UK)
C. Weltens, Leuven (BE)
Phase I-II PRC Experts:
J. Cassidy, Glasgow (UK)
M. De Jonge, Rotterdam (NL)
H. Dumez, Leuven (BE)
G. Eckhardt, Denver (US)
H.W. Hirte, Hamilton (CA)
I.R. Judson, London (UK)
P.J. O’Dwyer, Philadelphia (US)
W. Parulekar, Kingston (CA)
A. Ravaud, Bordeaux (FR)
L. Seymour, Kingston (CA)
L. Siu, Toronto (CA)
Ex Officio:
D. Lacombe, Brussels (BE)
F. Meunier, Brussels (BE)
R. Sylvester, Brussels (BE)
M. van Glabbeke, Brussels (BE)
Submission of outlines and protocols to the EORTC Protocol Review Committee
For each study proposed by an EORTC Group, an outline should be submitted to the EORTC PRC via the Internet. The outline should briefly describe and justify the principal parameters of the trial (objectives, principal eligibility criteria, therapeutic interventions, end-points, statistical design, companion studies and translational research projects) in such a way that the PRC will be able to assess the scientific value of the proposed study. The outline should also identify a Study Coordinator appointed by the EORTC Group(s), and eventual non-EORTC partners. All submitted outlines must be approved by the EORTC Group Chairman.
Prior to PRC submission, the study proposal should have been approved by the EORTC Executive Committee. EPOD will be in charge of the submission process. Groups are encouraged to discuss their projects with EPOD prior to submitting to the EORTC Executive Committee. EPOD was established to support the groups in streamlining their projects and strategies along the EORTC strategy defined by the EORTC Board.
For studies that might contribute to a new drug development project, the Groups are advised to consult the NDAC. For studies including a Translational Research project, the Groups are advised to consult the TRAC. Eventual support of the NDAC or of the TRAC should be notified at the time of outline submission.
An outline can only be submitted to the PRC once it has an initial budget and feasibility go-ahead from the Project and Budget Development Department.
The first PRC decision will be notified to the EORTC Study Coordinator(s), the EORTC Group
Chairman and the EORTC HQ team within one month of receipt of the outline (approval, resubmission
or rejection).
Full Protocol Submission
Full protocols are developed in a modular way with the logistical support of the HQ Protocol Help
Desk (PHD) and of the HQ team. Appropriate instructions, guidelines and templates will be addressed
to the Study Coordinator by the PHD shortly after outline approval.
When the final version of the full protocol is available, the Study Coordinator in collaboration with the HQ team should send a submission letter (or e-mail) to the PRC secretariat, which includes the description of eventual differences between the accepted outline and the full protocol.
The final protocol version will be submitted to an internal revision process within the HQ, to check adherence with the PRC approved outline, compliance with EORTC Policies and with EORTC Standard Operating Procedures, and to detect eventual discrepancies or inconsistencies that might affect the conduct and/or the management of the study. In case of major discrepancies with the original outline and/or irresolvable disagreement with the internal reviewers, the protocol will be resubmitted to the PRC experts.
All Study Coordinators need to complete a conflict of interest form, according to the EORTC Conflict
of Interest and Confidentiality Policy, and sign the document entitled “Tasks & responsibilities of Study
Coordinators”. Both documents are sent to the Study Coordinator at the time of outline approval
and must be signed before submission of the full protocol.
Intergroup Studies
Intergroup studies should follow the EORTC Intergroup Policy. If the trial is coordinated by an EORTC
Group or the EORTC HQ, the EORTC approval will be obtained through the usual submission
procedure (see above). If EORTC is neither the Coordinating Group, nor the Coordinating data
centre, the EORTC Group(s) should appoint an “EORTC Coordinator” who will complete an outline
questionnaire (even if the full protocol is already available) and send to the PRC secretariat a copy of all
available documentation of prior peer reviews of the project (preferable as electronic documents).
If the study is already active in another group, the reasons why the EORTC will join the trial at a late stage should be explained in the comment section of the outline questionnaire. If the full protocol is already finalized, it should be sent to the PRC secretariat at the time of outline submission. If the “EORTC Group Specific Appendix” (GSA) is already finalized and approved by the EORTC Regulatory Affairs and Intergroup Unit, the PRC Secretariat should be informed. Development of the full protocol is normally the responsibility of the Coordinating Group. The EORTC HQ will develop an “EORTC GSA”. The further review process will be decided by the PRC on the basis of the information provided at the time of outline submission.
Amendments
After PRC approval, any modifications to the protocol, PIS/IC or GSA must be discussed and
subsequently submitted or notified to the PRC, as appropriate. The changes will be reviewed, approved
and implemented in the protocol, and a new version issued. The HQ will make new versions available
on the web site, circulate the amendment and the new version of the protocol to all investigators, and
will inform health authorities and ethics committees when needed.
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Please note that electronic format is preferred for all documents. |