Abstract

Committee members are statisticians, clinical trial associates, data managers and information technology people. They offer methodological advice and support to clinical teams and researcher, to develop, initiate, conduct, manage, analyze 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-hematology. IMMC role is particularly important in international projects which require a strong coordination activity.

Scientific Aims

Our main aim is to provide expertise and support in issues related to methodology for all scientific activities of the I-BFM. Focusing on clinical research, the tasks range from support in designing, coordinating, and executing clinical trials, regulatory advice, support in data base design and implementation and issues related to statistical methodology from the statistical design, the analysis to the final publication.

The ongoing evolution in medicine as well as unaddressed methodologically needs, asks for refined and novel approaches of clinical trial operations, IT-support and statistical design and analysis. The IMMC aims to share experiences on methodological developments between the methodologists and between IMMC-members and the other I-BFM researchers and to provide state-of-the-art expertise.

Open and completed clinical trials

IMMC members are involved in many clinical trials and projects promoted within the I-BFM-SG. More details can be found in the pages dedicated to the ALL Committee, AML Committee, etc. International projects include the initiatives of the ‘Ponte di Legno’ consortium of ALL study groups, which are focused on the improvement of overall survival in uncommon subgroups of childhood ALL.

Selected methodological publications

The IMMC papers listed below represent a selection of papers on methodological/statistical issues authored by IMMC members. For papers on clinical trials and research projects, 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

Bernasconi DP, Rebora P, et al. Survival probabilities with time-dependent treatment indicator: quantities and non-parametric estimators. Stat Med. 2016 Mar 30

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)

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).

Rebora P, Galimberti S, Valsecchi MG. Using multiple timescale models for the evaluation of a time-dependent treatment. Stat Med. 2015 Dec 10

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

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.

Pötschger U, Heinzl H., Valsecchi M.G., Mittlböck M. Assessing the effect of a partly unobserved, exogenous, binary time-dependent covariate on survival probabilities using generalised pseudo-values. BMC Med Res Methodol. 2018

Mittlböck M. Pötschger U. Heinzl H. Weighted pseudo-values for partly unobserved group membership in paediatric stem cell transplantation studies. Stat Methods Med Res. 2022

Committee members

Helga Arnardottir, Andrea Barth, Joanne Chuah, Cristian Ciria, Carin Darbin-Korbijn, Paola De Lorenzo, Evgenia Glogova, Hester De Groot, Hanneke De Ridder, Dimitros Doganis, Alexandra Fischer, Marta Fiocco, Petr Gajdos, Stefania Galimberti, Akiko Kada, Karolina Kramarzora, Paulina Kurzmann, Jan Lieverst, Mats Heyman, Iveta Janotova, Ulrike Meyer, Naomi Litichever, Corinna Meier-Windhorst, Anthea N, Peter Nölke, Catriona Parker, Bettina Paul, Ulrike Pötschger, Ardine Reedijk, Roberto Rondelli, Ronit Nirel, Akiko Saito, Toshiki Saito, Erdogan Sarper, Nazan Saper, Daniela Silvestri, Stefan Suciu, Tom Groeneveld, Alena Vrzalova  Maria Grazia Valsecchi, Martin Zimmermann.