International Drug Development Institute (Belgium)

Publications in OpenAlex of which a co-author is affiliated to this organization

All publications | By field | By subfield

All publications [Next]
Title DOI
https://doi.org/10.1007/s00726-007-0540-1 A MBP-FAAH fusion protein as a tool to produce human and rat fatty acid amide hydrolase: expression and pharmacological comparison
https://doi.org/10.1097/cco.0b013e32830218fe Endpoints and surrogate endpoints in colorectal cancer: a review of recent developments
https://doi.org/10.1016/j.clbc.2011.04.001 Concurrent Bevacizumab with a Sequential Regimen of Doxorubicin and Cyclophosphamide Followed by Docetaxel and Capecitabine as Neoadjuvant Therapy for HER2− Locally Advanced Breast Cancer: A Phase II Trial of the NSABP Foundation Research Group
https://doi.org/10.1093/annonc/mds627 Overall survival benefit for sequential doxorubicin–docetaxel compared with concurrent doxorubicin and docetaxel in node-positive breast cancer—8-year results of the Breast International Group 02-98 phase III trial
https://doi.org/10.1177/1740774519862564 Detection of atypical data in multicenter clinical trials using unsupervised statistical monitoring
https://doi.org/10.1177/0962280209105015 A unified framework for the evaluation of surrogate endpoints in mental-health clinical trials
https://doi.org/10.1177/0962280217718582 A Poisson approach to the validation of failure time surrogate endpoints in individual patient data meta-analyses
https://doi.org/10.1097/cco.0b013e32835ff2fe Omics-based clinical trial designs
https://doi.org/10.1007/s10147-020-01726-6 Central statistical monitoring of investigator-led clinical trials in oncology
https://doi.org/10.3233/jad-142886 Correcting for the Absence of a Gold Standard Improves Diagnostic Accuracy of Biomarkers in Alzheimer’s Disease
https://doi.org/10.1200/jco.2019.37.4_suppl.tps479 Avenger 500, a phase III open-label randomized trial of the combination of CPI-613 with modified FOLFIRINOX (mFFX) versus FOLFIRINOX (FFX) in patients with metastatic adenocarcinoma of the pancreas.
https://doi.org/10.1177/0962280220966629 Unbiasedness and efficiency of non-parametric and UMVUE estimators of the probabilistic index and related statistics
https://doi.org/10.1186/s40880-016-0166-3 Study protocol of the Asian XELIRI ProjecT (AXEPT): a multinational, randomized, non-inferiority, phase III trial of second-line chemotherapy for metastatic colorectal cancer, comparing the efficacy and safety of XELIRI with or without bevacizumab versus FOLFIRI with or without bevacizumab
https://doi.org/10.1007/s12561-020-09268-1 Assessing Treatment Benefit in Immuno-oncology
https://doi.org/10.1016/j.annonc.2021.05.055 SO-31 ASPEN-01: A phase 1 study of ALX148, a CD47 blocker, in combination with trastuzumab, ramucirumab and paclitaxel in patients with second-line HER2-positive advanced gastric or gastroesophageal junction cancer
https://doi.org/10.1007/s43441-021-00341-5 Detection of Fraud in a Clinical Trial Using Unsupervised Statistical Monitoring
https://doi.org/10.1001/jamanetworkopen.2019.11750 Evaluation of Continuous Tumor-Size–Based End Points as Surrogates for Overall Survival in Randomized Clinical Trials in Metastatic Colorectal Cancer
https://doi.org/10.1016/j.ctrv.2016.09.015 Health-related quality of life assessment in contemporary phase III trials in advanced colorectal cancer
https://doi.org/10.1097/cco.0000000000000636 Statistical aspects in adjuvant and neoadjuvant trials for gastrointestinal cancer in 2020: focus on time-to-event endpoints
https://doi.org/10.1016/j.clbc.2016.07.008 Epirubicin With Cyclophosphamide Followed by Docetaxel With Trastuzumab and Bevacizumab as Neoadjuvant Therapy for HER2-Positive Locally Advanced Breast Cancer or as Adjuvant Therapy for HER2-Positive Pathologic Stage III Breast Cancer: A Phase II Trial of the NSABP Foundation Research Group, FB-5
https://doi.org/10.1080/0284186x.2020.1809704 Feasibility and clinical impact of routine molecular testing of gastrointestinal cancers at a tertiary centre with a multi-gene, tumor-agnostic, next generation sequencing panel
https://doi.org/10.1007/s13300-021-01030-0 Impact of Age on the Effectiveness and Safety of Insulin Glargine 300 U/mL: Results from the REALI European Pooled Data Analysis
https://doi.org/10.1007/s13300-023-01375-8 Effectiveness and Safety of iGlarLixi (Insulin Glargine 100 U/mL Plus Lixisenatide) in Type 2 Diabetes According to the Timing of Daily Administration: Data from the REALI Pooled Analysis
https://doi.org/10.1093/annonc/mdw372.01 Metastasis free survival (MFS) is a surrogate for overall survival (OS) in localized prostate cancer (CaP)
https://doi.org/10.1002/pst.2156 Operational characteristics of generalized pairwise comparisons for hierarchically ordered endpoints
https://doi.org/10.1136/jitc-2021-sitc2021.498 498 Evorpacept (ALX148), a CD47 myeloid checkpoint inhibitor, in patients with head and neck squamous cell carcinoma (HNSCC) and with gastric/gastroesophageal cancer (GC); ASPEN-01
https://doi.org/10.1200/jco.2023.41.16_suppl.5070 Assessing PSA levels as prognostic of overall survival (OS) in men with metastatic hormone-sensitive prostate cancer (mHSPC).
https://doi.org/10.1002/sim.6733 Development of a diagnostic test based on multiple continuous biomarkers with an imperfect reference test
https://doi.org/10.1158/1538-7445.sabcs19-p5-06-02 Abstract P5-06-02: Pathologic complete response (pCR) and prognosis following neoadjuvant chemotherapy plus anti-HER2 therapy of HER2-positive early breast cancer (EBC)
https://doi.org/10.1002/bimj.201900354 A new measure of treatment effect in clinical trials involving competing risks based on generalized pairwise comparisons
https://doi.org/10.1007/s13300-021-01179-8 Does Gender Influence the Effectiveness and Safety of Insulin Glargine 300 U/ml in Patients with Uncontrolled Type 2 Diabetes? Results from the REALI European Pooled Analysis
https://doi.org/10.1111/dom.15027 iGlarLixi (insulin glargine 100  U / ml plus lixisenatide) is effective and well tolerated in people with uncontrolled type 2 diabetes regardless of age: A REALI pooled analysis of prospective real‐world data
https://doi.org/10.1093/jnci/djad152 Time to deterioration of patient-reported outcomes as a surrogate of overall survival: a meta-analysis
https://doi.org/10.1093/jnci/djab218 Clinical Trial Endpoints in Metastatic Cancer: Using Individual Participant Data to Inform Future Trials Methodology
https://doi.org/10.1016/j.annonc.2022.07.1824 1746P Disease-free survival (DFS) and distant metastasis-free survival (DMFS) as surrogates for overall survival (OS) in adjuvant treatment of muscle-invasive bladder cancer (MIBC)
https://doi.org/10.1200/jco.23.01196 Early Efficacy End Points in Neoadjuvant Rectal Cancer Trials: Surrogacy Revisited
https://doi.org/10.1007/s43441-024-00613-w Does Central Statistical Monitoring Improve Data Quality? An Analysis of 1,111 Sites in 159 Clinical Trials
https://doi.org/10.1007/s43441-022-00470-5 Does Central Monitoring Lead to Higher Quality? An Analysis of Key Risk Indicator Outcomes
https://doi.org/10.1038/s41416-023-02443-3 Outcomes of relapsed clinical stage I versus de novo metastatic testicular cancer patients: an analysis of the IGCCCG Update database
https://doi.org/10.1080/00015458.2018.1470276 Impact of a prehospital discrimination between trauma patients with or without early acute coagulopathy of trauma and the need for damage control resuscitation: rationale and design of a multicenter randomized phase II trial
https://doi.org/10.1186/s12874-022-01731-5 The case against censoring of progression-free survival in cancer clinical trials – A pandemic shutdown as an illustration
https://doi.org/10.1002/pst.2271 On the use of extreme value tail modeling for generalized pairwise comparisons with censored outcomes
https://doi.org/10.1186/s13023-023-02943-8 Generalized pairwise comparisons of prioritized outcomes are a powerful and patient-centric analysis of multi-domain scores
https://doi.org/10.1016/j.esmogo.2024.100067 Efficacy and safety of short-course radiotherapy versus total neoadjuvant therapy in older rectal cancer patients: a randomised pragmatic trial (SHAPERS)
https://doi.org/10.1016/j.compbiolchem.2024.108094 A varying-coefficient model for the analysis of methylation sequencing data
https://doi.org/10.1016/j.cct.2021.106400 Impact of follow-up on generalized pairwise comparisons for estimating the irinotecan benefit in advanced/metastatic gastric cancer
https://doi.org/10.1016/j.oor.2024.100706 Neoadjuvant cytokine (IRX-2) immunotherapy for resectable oral cavity carcinoma: Final results of the INSPIRE trial
https://doi.org/10.1093/bioadv/vbaf126 A hierarchical negative-binomial model for analysis of correlated sequencing data: practical implementations
https://doi.org/10.1016/j.ctrv.2025.103045 Clinical trials for older cancer patients: A systematic review
https://doi.org/10.1182/blood.v92.5.1793 Anemia in Children With Cancer Is Associated With Decreased Erythropoietic Activity and Not With Inadequate Erythropoietin Production
https://doi.org/10.1016/0731-7085(91)80073-i The use of microdialysis for the determination of plasma protein binding of drugs
https://doi.org/10.1046/j.1423-0410.2003.00278.x Pharmacokinetics of total immunoglobulin G and immunoglobulin G subclasses in patients undergoing replacement therapy for primary immunodeficiency syndromes
https://doi.org/10.1080/0266476022000023776 Validation of a longitudinally measured surrogate marker for a time-to-event endpoint
https://doi.org/10.1007/s10985-007-9079-4 Exploring and validating surrogate endpoints in colorectal cancer
https://doi.org/10.1007/s10147-015-0877-5 Data-driven risk identification in phase III clinical trials using central statistical monitoring
https://doi.org/10.1007/s00394-013-0553-3 Markers for nutrition studies: review of criteria for the evaluation of markers
https://doi.org/10.1097/iae.0000000000000283 STEREOTACTIC RADIOTHERAPY FOR WET AGE-RELATED MACULAR DEGENERATION (INTREPID)
https://doi.org/10.1093/annonc/mdr547 The ARCAD advanced colorectal cancer database—open for business
https://doi.org/10.1056/nejmc1609993 Adaptive Randomization of Neratinib in Early Breast Cancer
https://doi.org/10.1136/bjophthalmol-2018-311865 Microvascular abnormalities secondary to radiation therapy in neovascular age-related macular degeneration: findings from the INTREPID clinical trial
https://doi.org/10.1016/j.ejca.2013.09.023 A phase III adjuvant randomised trial of 6 cycles of 5-fluorouracil–epirubicine–cyclophosphamide (FEC100) versus 4 FEC 100 followed by 4 Taxol (FEC-T) in node positive breast cancer patients (Trial B2000)
https://doi.org/10.1002/sim.6445 Evaluation of treatment efficacy using a Bayesian mixture piecewise linear model of longitudinal biomarkers
https://doi.org/10.1093/annonc/mdv135 Postoperative irinotecan in resected stage II–III rectal cancer: final analysis of the French R98 Intergroup trial
https://doi.org/10.1186/1745-6215-12-86 Assessment of the consistency and robustness of results from a multicenter trial of remission maintenance therapy for acute myeloid leukemia
https://doi.org/10.1182/blood.v118.21.1877.1877 Multivariate Modelling Reveals Evidence of a Dose-Response Relationship in Phase 2 Studies of Single-Agent Carfilzomib
https://doi.org/10.3233/jad-150511 Transferring Cut-off Values between Assays for Cerebrospinal Fluid Alzheimer’s Disease Biomarkers
https://doi.org/10.1016/s0923-7534(19)66492-6 O-0028 Adjuvant Folfox4 +/- Cetuximab in KRAS Wild-Type Patients with Resected Stage III Colon Cancer Results from the Petacc8 Intergroup Trial
https://doi.org/10.1007/0-387-27080-9_18 An Alternative Measure for Meta-analytic Surrogate Endpoint Validation
https://doi.org/10.1007/s10147-009-0879-2 Contributions of meta-analyses based on individual patient data to therapeutic progress in colorectal cancer
https://doi.org/10.1634/theoncologist.2011-0332 The ARCAD Clinical Trials Program: An Update and Invitation
https://doi.org/10.21037/atm.2018.05.16 The search for surrogate endpoints for immunotherapy trials
https://doi.org/10.1158/0008-5472.sabcs-09-64 Analysis of Fcγ Receptor IIA & IIIA Polymorphisms: Correlation with Outcome in Trastuzumab-Treated HER2/Neu Amplified Early and Metastatic Breast Cancer Patients.
https://doi.org/10.1002/cncr.33828 Results of a randomized phase 3 study of oral sapacitabine in elderly patients with newly diagnosed acute myeloid leukemia (SEAMLESS)
https://doi.org/10.1016/j.clml.2015.09.005 Relationship Between Carfilzomib Dose and Efficacy Outcomes in Patients With Relapsed and/or Refractory Multiple Myeloma
https://doi.org/10.1200/jco.21.02299 JCOG0603: Are We Really Sure This Was a Negative Trial?
https://doi.org/10.3390/cancers15184669 Trial Design for Cancer Immunotherapy: A Methodological Toolkit
https://doi.org/10.1056/nejmc2401669 Acoramidis in Transthyretin Amyloid Cardiomyopathy
https://doi.org/10.1093/jnci/89.11.790 Economic Implications of Hepatic Arterial Infusion Chemotherapy in Treatment of Nonresectable Colorectal Liver Metastases
https://doi.org/10.1002/sim.4780120517 Interim analyses, stopping rules and data monitoring in clinical trials in europe
https://doi.org/10.1016/s0197-2456(96)00225-5 The trials of Dr. Bernard Fisher: A European perspective on an American episode
https://doi.org/10.1007/bf02208345 The CRP initial response to treatment as prognostic factor in patients with polymyalgia rheumatica
Meta-analysis: methods, strengths, and weaknesses.
https://doi.org/10.1093/annonc/mdn385 Is risk of central nervous system (CNS) relapse related to adjuvant taxane treatment in node-positive breast cancer? Results of the CNS substudy in the intergroup phase III BIG 02-98 trial
https://doi.org/10.1097/01.cco.0000142925.99075.a0 Challenges in breast cancer clinical trial design in the postgenomic era
https://doi.org/10.1200/jco.2007.14.5268 Are Prostate-Specific Antigen Changes Valid Surrogates for Survival in Hormone-Refractory Prostate Cancer? A Meta-Analysis Is Needed!
https://doi.org/10.1080/10826079308019651 Collaborative Study of the Analysis of Tetracycline by Liquid Chromatography on Poly(Styrene-Divinylbenzene)
https://doi.org/10.1093/annonc/mdw047 Statistical controversies in clinical research: statistical significance—too much of a good thing …
https://doi.org/10.1016/j.jprot.2013.12.013 The use of the isotopic distribution as a complementary quality metric to assess tandem mass spectra results
https://doi.org/10.1200/jco.2009.27.15_suppl.580 Epirubicin plus cyclophosphamide followed by docetaxel plus trastuzumab and bevacizumab as neoadjuvant therapy for HER2-positive locally advanced breast cancer (LABC) or as adjuvant therapy for HER2-positive pathologic stage III breast cancer (PS3BC): A phase II trial of the NSABP Foundation Research Group
https://doi.org/10.1158/0008-5472.sabcs-09-601 Overall Survival Benefit for Sequential Doxorubicin-Docetaxel Compared to Concomitant Doxorubicin and Docetaxel in Node-Positive Breast Cancer. 8-Yr. Results of the Breast International Group (BIG) 2-98 Phase III Adjuvant Trial.
https://doi.org/10.1093/occmed/kqn089 Work-related sickness absences and mandatory occupational health surveillance
https://doi.org/10.1200/jco.2013.31.15_suppl.lba4002 SAMIT: A phase III randomized clinical trial of adjuvant paclitaxel followed by oral fluorinated pyrimidines for locally advanced gastric cancer.
https://doi.org/10.1200/jco.2013.31.15_suppl.3533 Individual patient data (IPD) analysis of progression-free survival (PFS) versus overall survival (OS) as an endpoint for metastatic colorectal cancer (mCRC) in modern trials: Findings from the 16,700 patients (pts) ARCAD database.
https://doi.org/10.1200/jco.2013.31.15_suppl.lba4001 Lapatinib in combination with capecitabine plus oxaliplatin (CapeOx) in HER2 positive advanced or metastatic gastric (A/MGC), esophageal (EAC), or gastroesophageal (GEJ) adenocarcinoma: The LOGiC trial.
https://doi.org/10.1007/s13300-021-01031-z Glycaemic Control with Insulin Glargine 300 U/mL in Individuals with Type 2 Diabetes and Chronic Kidney Disease: A REALI European Pooled Data Analysis
https://doi.org/10.1200/jco.2013.31.15_suppl.tps8122 A phase III comparative study of nivolumab (anti-PD-1; BMS-936558; ONO-4538) versus docetaxel in patients with previously treated advanced or metastatic squamous cell non-small cell lung cancer (NSCLC).
https://doi.org/10.1200/jco.2013.31.15_suppl.tps3117 Intergroup ALFA/GOELAMS randomized phase II trial of lirilumab anti-KIR monoclonal antibody (IPH2102/BMS986015) as maintenance treatment in elderly patients with acute myeloid leukemia (EFFIKIR trial).
https://doi.org/10.1158/1078-0432.ccr-15-1047 Neoadjuvant as Future for Drug Development in Breast Cancer—Letter
https://doi.org/10.1200/jco.2014.32.15_suppl.3538 Early predictors of prolonged overall survival (OS) in patients (pts) on first-line chemotherapy (CT) for metastatic colorectal cancer (mCRC): An ARCAD study with individual patient data (IPD) on 10,962 pts.
https://doi.org/10.1001/jamaoncol.2016.3941 Adoption of Pathologic Complete Response as a Surrogate End Point in Neoadjuvant Trials in HER2-Positive Breast Cancer Still an Open Question