Final publication of trial results
Trial results will always be submitted for publication in a peer reviewed scientific journal regardless of the outcome of the trial – unless the trial was terminated prematurely and did not yield sufficient data for a publication.
The final publication of the trial results will be written by the Principal Investigator, the Co-investigators and the trial statistician on the basis of the statistical analysis performed by the trial statistician. A draft manuscript will be submitted for review to:
♦ All co-authors
♦ The chair of the relevant HOVON working group, who is entitled to share and discuss the manuscript with working group members
♦ An industry partner if so agreed in the contract between HOVON and company
After revision the final manuscript is submitted to the HOVON secretary for review of compliance with this policy. After approval by the HOVON board the manuscript will be sent to a peer reviewed
scientific journal.
Authorship
Authors of the main manuscript will include the Principal Investigator, the Co-investigators, investigators who have included more than 5% of the evaluable patients in the trial (by order of inclusion rate), the trial statistician and the trial manager. If a substantial part of the publication is based on centrally reviewed data (e.g. cytogenetics or pathology), the central reviewer will be
included as author. Others who have made a significant contribution to the trial may also be included as author, or otherwise will be included in the acknowledgement.
Authors of correlative manuscripts (e.g. results of side studies) will include the Principal Investigator, the Co-investigators, and those persons who have made a significant contribution to the published results.
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The Principal Investigator should discuss and decide on the matter of authorship of the main manuscript prior to the start of the trial – with the exception of authors included on account of
inclusion rate. The Principal Investigator is urged to use the maximum number of authors allowed by the journal to the full extent.
Interim and partial publications
Interim publications, abstracts or presentations of the study may include demographic data, overall results and prognostic factor analyses, results for secondary endpoints, but no comparisons between randomized treatment arms for the primary endpoint may be made publicly available before the recruitment is discontinued.
Investigators participating in the trial have a right to publish results from data they collected for the study. The Principal Investigator, the Co-investigator(s) and the trial statistician must approve any such publication, abstract or presentation based on patients included in this study. This is applicable to any individual patient or any subgroup of the trial patients. Such a publication cannot include any comparisons between randomized treatment arms nor an analysis of any of the study endpoints unless the final results of the trial have already been published.
Abstracts and presentations
Abstracts and presentations at public meetings will represent the trial as a project under HOVON affiliation. The abstract or presentation should not be represented under affiliation of the working group or a specific hospital.
Slides will be designed using the HOVON style template and any other presentation materials will show the HOVON logo.
If the trial is conducted in partnership with a co-sponsor (e.g. intergroup trial), the abstract and presentation should represent the co-sponsor contribution and slides may show the co-sponsor logo in addition to the HOVON logo.
Prior to its public use, the abstract or presentation is submitted to the HOVON secretary for review of compliance with this policy.
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Glossary of abbreviations
(in alphabetical order)AE Adverse Event
ANC Absolute Neutrophil Count
BCL-U
BM
B-cell lymphomas, unclassifiable with features intermediate between diffuse large B cell lymphoma and Burkitt lymphoma
Bone Marrow
CA Competent Authority
COO Cell of origin
CR Complete Remission
CRF Case Report Form
CTCAE Common Terminology Criteria for Adverse Events
CRu Complete remission unconfirmed
CSF Cerebro Spinal Fluid
CT Computed Tomography
DH Double Hit
DLBCL Diffuse Large B cell Lymphoma DSMB Data Safety and Monitoring Board
ECG Electrocardiogram
EFS Event Free Survival
18F-FDG 18F-Fludeoxyglucose
FISH Fluorescence In Situ Hybridization
FNA Fine Needle Aspirate
GCP Good Clinical Practice
GEP Gene expression profiling
Hb Hemoglobin
HBV Hepatitis B virus
HIV Human Immunodeficiency Virus
HOVON Dutch-Belgian Hematology-Oncology Cooperative Group
ICH International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use
IHC Immunohistochemistry
IMP Investigational Medicinal Product IPI International Prognostic Index
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LDH Lactate Dehydrogenase
LVEF Left Ventricular Ejection Fraction
METC Medical Ethical Review Committee
MM Multiple Myeloma
MTX Methrotrexaat
MUGA MUltiple Gated Acquisition
NaCl Sodium Chloride
NCI National Cancer Institute
NYHA New York Heart Association
OS Overall Survival
PB Peripheral Blood
PD Progressive Disease
PET Positron Emission Tomography
PFS Progression Free Survival
PJP Pneumocystis jirovecii Pneumonia
p.o. Per Os
PPP Pregnancy Prevention Risk Management Program
PR Partial Response
QoL Quality of Life
R-CHOP
R2CHOP
Rituximab, Cyclophosphamide, Hydrochloride-daunorubicin, Vincristine and Prednisone
Rituximab, Cyclophosphamide, Hydrochloride-daunorubicin, Vincristine, Prednisone and lenalidomide (Revlimid)
RD Relapsed Disease
SAE Serious Adverse Event
SD Stable Disease
SH Single Hit
SPM Second Primary Malignancy
SUSAR Suspected Unexpected Serious Adverse Reaction
TH Triple Hit
TMA Tissue Micro Array
ULN Upper Limit of Normal
VTE Venous Thromboembolism
WHO World Health Organization
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Appendix A
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