International Drug Development Institute (Belgium)

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Title DOI
https://doi.org/10.1200/jco.2004.05.113 FOLFIRI Followed by FOLFOX6 or the Reverse Sequence in Advanced Colorectal Cancer: A Randomized GERCOR Study
https://doi.org/10.1056/nejmoa0910383 Adjuvant Trastuzumab in HER2-Positive Breast Cancer
https://doi.org/10.1093/jnci/djj052 Gene Expression Profiling in Breast Cancer: Understanding the Molecular Basis of Histologic Grade To Improve Prognosis
https://doi.org/10.1093/jnci/djj329 Validation and Clinical Utility of a 70-Gene Prognostic Signature for Women With Node-Negative Breast Cancer
https://doi.org/10.1158/1078-0432.ccr-06-2765 Strong Time Dependence of the 76-Gene Prognostic Signature for Node-Negative Breast Cancer Patients in the TRANSBIG Multicenter Independent Validation Series
https://doi.org/10.1158/1078-0432.ccr-07-4756 Biological Processes Associated with Breast Cancer Clinical Outcome Depend on the Molecular Subtypes
https://doi.org/10.1016/s1470-2045(14)70069-5 Clinical validity of circulating tumour cells in patients with metastatic breast cancer: a pooled analysis of individual patient data
https://doi.org/10.1056/nejm199503093321002 The Effect of Debulking Surgery after Induction Chemotherapy on the Prognosis in Advanced Epithelial Ovarian Cancer
https://doi.org/10.1093/biostatistics/1.1.49 The validation of surrogate endpoints in meta-analyses of randomized experiments
https://doi.org/10.1016/s1470-2045(17)30717-9 Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial
https://doi.org/10.1016/s1470-2045(15)00551-3 Neratinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (ExteNET): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial
https://doi.org/10.1158/0008-5472.sabcs-09-62 Phase III Randomized Trial Comparing Doxorubicin and Cyclophosphamide Followed by Docetaxel (AC→T) with Doxorubicin and Cyclophosphamide Followed by Docetaxel and Trastuzumab (AC→TH) with Docetaxel, Carboplatin and Trastuzumab (TCH) in Her2neu Positive Early Breast Cancer Patients: BCIRG 006 Study.
https://doi.org/10.2307/2533853 Criteria for the Validation of Surrogate Endpoints in Randomized Experiments
https://doi.org/10.1016/s0140-6736(00)02528-9 Relation between tumour response to first-line chemotherapy and survival in advanced colorectal cancer: a meta-analysis
https://doi.org/10.1093/jnci/djm024 Endpoints in Adjuvant Treatment Trials: A Systematic Review of the Literature in Colon Cancer and Proposed Definitions for Future Trials
https://doi.org/10.1200/jco.2007.11.8836 Progression-Free Survival Is a Surrogate for Survival in Advanced Colorectal Cancer
https://doi.org/10.1038/nrclinonc.2010.43 Biomarkers and surrogate end points—the challenge of statistical validation
https://doi.org/10.1016/s1470-2045(15)00051-0 Combination of everolimus with trastuzumab plus paclitaxel as first-line treatment for patients with HER2-positive advanced breast cancer (BOLERO-1): a phase 3, randomised, double-blind, multicentre trial
https://doi.org/10.1093/jnci/djy018 Circulating Tumor Cells in Breast Cancer Patients Treated by Neoadjuvant Chemotherapy: A Meta-analysis
https://doi.org/10.1016/s1470-2045(11)70259-5 Therapeutic vaccination with TG4010 and first-line chemotherapy in advanced non-small-cell lung cancer: a controlled phase 2B trial
https://doi.org/10.4103/2229-3485.159943 Common pitfalls in statistical analysis: Clinical versus statistical significance
https://doi.org/10.1002/sim.3923 Generalized pairwise comparisons of prioritized outcomes in the two‐sample problem
https://doi.org/10.1200/jco.18.01624 Randomized Phase II Study Evaluating Palbociclib in Addition to Letrozole as Neoadjuvant Therapy in Estrogen Receptor–Positive Early Breast Cancer: PALLET Trial
https://doi.org/10.1111/1467-9876.00244 Validation of Surrogate end Points in Multiple Randomized Clinical Trials with Failure Time end Points
https://doi.org/10.1002/pst.207 Surrogate threshold effect: an alternative measure for meta‐analytic surrogate endpoint validation
https://doi.org/10.1016/s1470-2045(11)70231-5 HER2 and TOP2A as predictive markers for anthracycline-containing chemotherapy regimens as adjuvant treatment of breast cancer: a meta-analysis of individual patient data
https://doi.org/10.1200/jco.22.02774 FOLFIRI Followed by FOLFOX6 or the Reverse Sequence in Advanced Colorectal Cancer: A Randomized GERCOR Study
https://doi.org/10.1002/(sici)1097-0258(19991230)18:24<3435::aid-sim365>3.0.co;2-o The role of biostatistics in the prevention, detection and treatment of fraud in clinical trials
https://doi.org/10.1093/jnci/djt270 Disease-Free Survival as a Surrogate for Overall Survival in Adjuvant Trials of Gastric Cancer: A Meta-Analysis
https://doi.org/10.1177/1740774507087554 Ensuring trial validity by data quality assurance and diversification of monitoring methods
https://doi.org/10.1016/s1470-2045(09)70023-3 Surrogate endpoints for overall survival in locally advanced head and neck cancer: meta-analyses of individual patient data
https://doi.org/10.1136/bmj.f457 Comparison of treatment effect sizes associated with surrogate and final patient relevant outcomes in randomised controlled trials: meta-epidemiological study
https://doi.org/10.1007/s10549-009-0512-0 The effect of body mass index on overall and disease-free survival in node-positive breast cancer patients treated with docetaxel and doxorubicin-containing adjuvant chemotherapy: the experience of the BIG 02-98 trial
https://doi.org/10.1093/jnci/djm287 Adjuvant Chemotherapy With Sequential or Concurrent Anthracycline and Docetaxel: Breast International Group 02 98 Randomized Trial
https://doi.org/10.1016/j.jval.2016.10.011 Time to Review the Role of Surrogate End Points in Health Policy: State of the Art and the Way Forward
https://doi.org/10.1093/annonc/mdp523 Progression-free survival as surrogate and as true end point: insights from the breast and colorectal cancer literature
https://doi.org/10.1586/erm.10.120 Integrating biomarkers in clinical trials
https://doi.org/10.1186/1471-2164-9-394 Comparison of prognostic gene expression signatures for breast cancer
https://doi.org/10.1200/jco.2016.66.6693 HER2 Gene Amplification Testing by Fluorescent In Situ Hybridization (FISH): Comparison of the ASCO-College of American Pathologists Guidelines With FISH Scores Used for Enrollment in Breast Cancer International Research Group Clinical Trials
https://doi.org/10.1002/bimj.201400049 Statistical evaluation of surrogate endpoints with examples from cancer clinical trials
https://doi.org/10.1200/jco.2006.10.4380 Reintroduction of Oxaliplatin Is Associated With Improved Survival in Advanced Colorectal Cancer
https://doi.org/10.1002/(sici)1097-0258(19991230)18:24<3435::aid-sim365>3.3.co;2-f The role of biostatistics in the prevention, detection and treatment of fraud in clinical trials
https://doi.org/10.1200/jco.2013.31.18_suppl.lba4001 Lapatinib in combination with capecitabine plus oxaliplatin (CapeOx) in HER2-positive advanced or metastatic gastric, esophageal, or gastroesophageal adenocarcinoma (AC): The TRIO-013/LOGiC Trial.
https://doi.org/10.1016/s1470-2045(21)00584-2 Evorpacept alone and in combination with pembrolizumab or trastuzumab in patients with advanced solid tumours (ASPEN-01): a first-in-human, open-label, multicentre, phase 1 dose-escalation and dose-expansion study
https://doi.org/10.1093/annonc/mdy214 Palbociclib as single agent or in combination with the endocrine therapy received before disease progression for estrogen receptor-positive, HER2-negative metastatic breast cancer: TREnd trial
https://doi.org/10.1007/s10549-012-2045-1 Final results of a multicenter phase II clinical trial evaluating the activity of single-agent lapatinib in patients with HER2-negative metastatic breast cancer and HER2-positive circulating tumor cells. A proof-of-concept study
https://doi.org/10.1016/s1470-2045(14)70025-7 Sequential paclitaxel followed by tegafur and uracil (UFT) or S-1 versus UFT or S-1 monotherapy as adjuvant chemotherapy for T4a/b gastric cancer (SAMIT): a phase 3 factorial randomised controlled trial
https://doi.org/10.1177/1740774512447898 A statistical approach to central monitoring of data quality in clinical trials
https://doi.org/10.1016/j.ejca.2010.12.015 Two or three year disease-free survival (DFS) as a primary end-point in stage III adjuvant colon cancer trials with fluoropyrimidines with or without oxaliplatin or irinotecan: Data from 12,676 patients from MOSAIC, X-ACT, PETACC-3, C-06, C-07 and C89803
https://doi.org/10.1056/nejmp1411794 Data Sharing, Year 1 — Access to Data from Industry-Sponsored Clinical Trials
https://doi.org/10.1080/2162402x.2015.1026529 Survivin-targeted immunotherapy drives robust polyfunctional T cell generation and differentiation in advanced ovarian cancer patients
https://doi.org/10.2217/fon-2019-0209 A Phase III Open-Label Trial to Evaluate Efficacy and Safety of CPI-613 Plus Modified FOLFIRINOX (MFFX) versus FOLFIRINOX (FFX) in Patients with Metastatic Adenocarcinoma of the Pancreas
Evorpacept alone and in combination with pembrolizumab or trastuzumab in patients with advanced solid tumours (ASPEN-01): a first-in-human, open-label, multicentre, phase 1 dose-escalation and dose-expansion study
https://doi.org/10.1038/nrclinonc.2017.8 Precision medicine needs randomized clinical trials
https://doi.org/10.1200/jco.22.02241 Pathologic Complete Response and Individual Patient Prognosis After Neoadjuvant Chemotherapy Plus Anti–Human Epidermal Growth Factor Receptor 2 Therapy of Human Epidermal Growth Factor Receptor 2–Positive Early Breast Cancer
https://doi.org/10.1016/j.ophtha.2013.02.016 Stereotactic Radiotherapy for Neovascular Age-related Macular Degeneration
https://doi.org/10.1016/j.ejca.2013.07.003 Combination of cisplatin/S-1 in the treatment of patients with advanced gastric or gastroesophageal adenocarcinoma: Results of noninferiority and safety analyses compared with cisplatin/5-fluorouracil in the First-Line Advanced Gastric Cancer Study
https://doi.org/10.1007/s10549-013-2444-y Immunohistochemistry and fluorescence in situ hybridization assessment of HER2 in clinical trials of adjuvant therapy for breast cancer (NCCTG N9831, BCIRG 006, and BCIRG 005)
https://doi.org/10.1200/jco.19.00858 Safety and Efficacy of T-DM1 Plus Neratinib in Patients With Metastatic HER2-Positive Breast Cancer: NSABP Foundation Trial FB-10
https://doi.org/10.1016/s1470-2045(18)30750-2 Disease-free survival as a surrogate for overall survival in patients with HER2-positive, early breast cancer in trials of adjuvant trastuzumab for up to 1 year: a systematic review and meta-analysis
https://doi.org/10.1111/biom.12245 On the Relationship between the Causal-Inference and Meta-Analytic Paradigms for the Validation of Surrogate Endpoints
https://doi.org/10.1001/jamaoncol.2015.6359 The Net Chance of a Longer Survival as a Patient-Oriented Measure of Treatment Benefit in Randomized Clinical Trials
https://doi.org/10.1007/s11060-016-2094-0 Cilengitide with metronomic temozolomide, procarbazine, and standard radiotherapy in patients with glioblastoma and unmethylated MGMT gene promoter in ExCentric, an open-label phase II trial
https://doi.org/10.1186/s13054-014-0648-0 Prehospital identification of trauma patients with early acute coagulopathy and massive bleeding: results of a prospective non-interventional clinical trial evaluating the Trauma Induced Coagulopathy Clinical Score (TICCS)
https://doi.org/10.1056/nejmp1610336 Data Sharing — Is the Juice Worth the Squeeze?
https://doi.org/10.1093/oncolo/oyac006 Surrogacy Beyond Prognosis: The Importance of “Trial-Level” Surrogacy
https://doi.org/10.1038/nrd.2016.81 Use of surrogate end points in healthcare policy: a proposal for adoption of a validation framework
https://doi.org/10.1200/jco.22.02363 Re-Evaluation of Pathologic Complete Response as a Surrogate for Event-Free and Overall Survival in Human Epidermal Growth Factor Receptor 2–Positive, Early Breast Cancer Treated With Neoadjuvant Therapy Including Anti–Human Epidermal Growth Factor Receptor 2 Therapy
https://doi.org/10.1186/s13045-016-0322-x Proceedings of the 2016 China Cancer Immunotherapy Workshop
https://doi.org/10.1136/bmjopen-2012-001802 Prediction of survival benefits from progression-free survival benefits in advanced non-small-cell lung cancer: evidence from a meta-analysis of 2334 patients from 5 randomised trials
https://doi.org/10.1016/j.ophtha.2023.02.001 A Randomized Controlled Trial of OPT-302, a VEGF-C/D Inhibitor for Neovascular Age-Related Macular Degeneration
https://doi.org/10.1007/978-1-4614-0140-7_5 On Stopping a Randomized Clinical Trial for Futility
https://doi.org/10.1186/s13690-021-00656-7 Disability and COVID-19: ensuring no one is left behind
https://doi.org/10.1371/journal.pone.0066848 Genomic Grade Index (GGI): Feasibility in Routine Practice and Impact on Treatment Decisions in Early Breast Cancer
https://doi.org/10.1001/jamaoncol.2022.3755 Surrogacy of Pathologic Complete Response in Trials of Neoadjuvant Therapy for Early Breast Cancer
https://doi.org/10.3390/cancers13215286 Comparison of 68Ga-Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography Computed Tomography (PET-CT) and Whole-Body Magnetic Resonance Imaging (WB-MRI) with Diffusion Sequences (DWI) in the Staging of Advanced Prostate Cancer
https://doi.org/10.1007/s10549-014-3221-2 Weekly paclitaxel and concurrent pazopanib following doxorubicin and cyclophosphamide as neoadjuvant therapy for HER-negative locally advanced breast cancer: NSABP Foundation FB-6, a phase II study
https://doi.org/10.1111/iej.13895 What ultimately matters in root canal treatment success and tooth preservation: A 25‐year cohort study
https://doi.org/10.1016/s1470-2045(24)00218-3 The tyranny of non-inferiority trials
https://doi.org/10.1200/jco.23.01535 Radiographic Progression-Free Survival and Clinical Progression-Free Survival as Potential Surrogates for Overall Survival in Men With Metastatic Hormone-Sensitive Prostate Cancer
https://doi.org/10.1016/j.jclinepi.2021.03.018 The Net Benefit of a treatment should take the correlation between benefits and harms into account
https://doi.org/10.1200/jco.22.02915 Ofranergene Obadenovec (Ofra-Vec, VB-111) With Weekly Paclitaxel for Platinum-Resistant Ovarian Cancer: Randomized Controlled Phase III Trial (OVAL Study/GOG 3018)
https://doi.org/10.1016/j.jacc.2023.06.047 Generalized Pairwise Comparisons to Assess Treatment Effects
https://doi.org/10.1002/bimj.202100354 Generalized pairwise comparisons for censored data: An overview
https://doi.org/10.1001/jamaoncol.2025.2026 Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer
https://doi.org/10.1016/j.eururo.2024.04.038 Refining Risk Stratification of High-risk and Locoregional Prostate Cancer: A Pooled Analysis of Randomized Trials
https://doi.org/10.1038/s41422-024-01026-y The 1% gift to humanity: The Human Genome Project II
https://doi.org/10.1016/s1470-2045(24)00648-x Dose optimisation to improve access to effective cancer medicines
https://doi.org/10.1016/j.jcpo.2025.100647 Central and Eastern Europe: A crucible for clinical cancer innovation?
https://doi.org/10.1053/jhep.2003.50474 A Pilot Study of Therapeutic Vaccination With Envelope Protein E1 in 35 Patients With Chronic Hepatitis C
https://doi.org/10.1002/(sici)1097-0258(19961230)15:24<2797::aid-sim290>3.0.co;2-v ON THE RELATIONSHIP BETWEEN RESPONSE TO TREATMENT AND SURVIVAL TIME
https://doi.org/10.1016/s0197-2456(02)00236-2 Statistical challenges in the evaluation of surrogate endpoints in randomized trials
https://doi.org/10.1016/s0093-7754(01)90247-7 Should Dukes' B patients receive adjuvant therapy? A statistical perspective
https://doi.org/10.1016/s0197-2456(00)00069-6 Fraud in Medical Research
https://doi.org/10.1200/jco.2004.06.924 Meta-Analyses Based on Abstracted Data: A Step in the Right Direction, but Only a First Step
https://doi.org/10.1002/sim.923 Evaluation of surrogate endpoints in randomized experiments with mixed discrete and continuous outcomes
https://doi.org/10.1038/449180a The road to recovery
https://doi.org/10.1245/aso.2006.07.003 Current Issues in Adjuvant Treatment of Stage II Colon Cancer
https://doi.org/10.1111/j.1467-985x.2004.00293.x The Validation of Surrogate End Points by using Data from Randomized Clinical Trials: A Case-Study in Advanced Colorectal Cancer
https://doi.org/10.1093/annonc/mdl173 Alternative clinical end points in rectal cancer—are we getting closer?