Information Management and Methodology Committee (IMM)

Committee Chairman:

Paola De Lorenzo

Committee Members:

Andrea Barth, Joanne Chuah, Paola De Lorenzo, Hester De Groot, Hanneke De Ridder, Dimitros Doganis, Alexandra Fischer, Marta Fiocco, Petr Gajdos, Stefania Galimberti, Akiko Kada, Jan Lieverst, Mats Heyman, Iveta Janotova, Ulrike Meyer, Naomi Litichever, Corinna Meier-Windhorst, Anthea N, Peter Nölke, Catriona Parker, Ulrike Pötschger, Roberto Rondelli, Ronit Nirel, Akiko Saito, Toshiki Saito, Erdogan Sarper, Daniela Silvestri, Stefan Suciu, Tom Groeneveld, Maria Grazia Valsecchi, Keith Wheatley, Martin Zimmermann.

Clinical Trials:

IMMC members are involved in many clinical trials and projects promoted within the I-BFM-SG. Most recent/on-going international clinical trials include AIEOP-BFM 2009, ALL SCTped FORUM 2012, EsPhALL, Interfant-06, IntreALL. International projects include the initiatives of the ‘Ponte di Legno’ consortium of ALL study groups, which are focussed on the improvement of overall survival in uncommon subgroups of childhood ALL. More details can be found in the pages dedicated to the ALL Committee, AML Committee, etc.

In addition, IMMC members actively participated into different tasks of the ENCCA project (‘European network for cancer research in children and adolescents’, www.encca.eu), a 5-year project which ended in December 2015 and was funded by the EU to promote and structure collaboration within the paediatric oncology community in Europe. In particular, IMMC was involved in the working package 6, ‘Standardised and innovative methodology for clinical trial design and analysis’ which included the following 4 tasks:

  • Task 6.1 (resp. MC Le Deley-IGR, L. Billingham-UB): ‘Statistical approaches to trial design for clinical research in rare diseases’
  • Task 6.2 (resp. MG Valsecchi-UNIMIB): ‘Statistical methods for the definition and validation of risk-based patient stratifications’
  • Task 6.3 (resp. U. Pötschger-CCRI, MG Valsecchi-UNIMIB): ‘Statistical approaches for the analysis of recurrent events (SAE) and competing events (composite endpoints) and long-term outcomes’
  • Task 6.4 (resp. MG Valsecchi-UNIMIB, M. Zimmermann-CAU): ‘Definition of disease-specific core datasets for pooled analysis.

Such research activities led to the development of guidelines and scientific publications.

IMMC members are actively cooperating with SIOP Europe (www.siope.eu). For instance, IMMC members collaborate on the ‘clinical trials facilitation platform’, a SIOPE project which aims to support the set-up of international clinical trials. This web-based toolkit will provide guidance documents and advice to accelerate clinical trial delivery and to optimise the quality of collaborative clinical trials.

Major Activities:

Committee members are statisticians, clinical trial associates, data managers and information technology people. They offer methodological advice and support to clinical teams, to develop, initiate, conduct, manage, analyse and report clinical studies. As such, this is a multidisciplinary committee which provide the other, disease-oriented I-BFM-SG Committees with its expertise for the successful implementation of studies in various fields of onco-haematology. IMMC role is particularly important in international projects which require a strong coordination activity.

Recent Publications:

Papers listed below represent a selection of papers on methodological/statistical issues authored by IMMC members. For papers on clinical trials, please visit the relevant pages of the other I-BFM-SG Committees.

Rebora P, Antolini L, et al. Crude incidence in two-phase designs in the presence of competing risks. BMC Med Res Methodol. 2016 Jan 11;16:5. doi: 10.1186/s12874-015-0103-1. PubMed PMID: 26754746; PubMed Central PMCID: PMC4710022.

Bernasconi DP, Rebora P, et al. Survival probabilities with time-dependent treatment indicator: quantities and non-parametric estimators. Stat Med. 2016 Mar 30;35(7):1032-48. doi: 10.1002/sim.6765. PubMed PMID: 26503800.

Rebora P, Valsecchi MG. Survival estimation in two-phase cohort studies with application to biomarkers evaluation. Stat Methods Med Res. 2016 Dec;25(6):2895-2908. PubMed PMID: 24845725.

Rebora P, Galimberti S, Valsecchi MG. Using multiple timescale models for the evaluation of a time-dependent treatment. Stat Med. 2015 Dec 10;34(28):3648-60. doi: 10.1002/sim.6597. PubMed PMID: 26215851.

Rota M, Antolini L, Valsecchi MG. Optimal cut-point definition in biomarkers: the case of censored failure time outcome. BMC Med Res Methodol. 2015 Mar 21;15:24. doi: 10.1186/s12874-015-0009-y. PubMed PMID: 25887743; PubMed Central PMCID: PMC4430986.

Vassal G, Fitzgerald E, et al. Challenges for children and adolescents with cancer in Europe: the SIOP-Europe agenda. Pediatr Blood Cancer.  2014 Sep;61(9):1551-7. doi: 10.1002/pbc.25044. PubMed PMID: 24706509; PubMed Central PMCID: PMC4285788.

Oosterveld M, Suciu S, et al. Specific scoring systems to predict survival of patients with high-risk myelodysplastic syndrome (MDS) and de novo acute myeloid leukemia (AML) after intensive antileukemic treatment based on results of the EORTC-GIMEMA AML-10 and intergroup CRIANT studies. Ann Hematol. 2015 Jan;94(1):23-34. doi: 10.1007/s00277-014-2177-y. PubMed PMID: 25096636.

Meetings:

Next:

The IMMC meets regularly once a year at the annual I-BFM-SG meeting.

Contact:

Paola De Lorenzo    paola.delorenzo@unimib.it