Data Scientist Beerse, Belgium
Since October 2016
How can real world data boost research? This is part of the EHR4CR project (Electronic Health Records for Clinical Research), an Inovative medecines initiative.
Clinical Research Manager Leuven, Belgium
Since September 2008
Background: In Belgium, bladder cancer (BC) is the fifth most common cancer in males. The per-patient lifetime cost is high. Previous epidemiological studies have consistently reported that selenium concentrations were inversely associated with the risk of BC. We therefore hypothesized that selenium may be suitable for chemoprevention of recurrence of BC.
Method: The SELEnium and BLAdder cancer Trial (SELEBLAT) was an academic phase III placebo-controlled, double-blind, randomized clinical trial designed to determine the effect of selenium on recurrence of non-muscle-invasive bladder cancer conducted in 14 Belgian hospitals. Patients were randomly assigned by a computer program to oral selenium yeast 200 mg once a day or placebo for three years, in addition to standard care. All study personnel and participants were blinded to treatment assignment for the duration of the study. All randomized patients were included in the intention to treat (ITT) and safety analyses. Per protocol analyses (PPA) included all patients in the study three months after start date.
Results: Between September 18, 2009 and April 18, 2013, 151 and 141 patients were randomized in the selenium and placebo group. Patients were followed till December 31, 2015. The ITT analysis resulted in 43 (28%;95% CI 0·21-0·35) and 45 (32%;95% CI, 0·24-0·40) recurrences in the selenium and placebo group. The hazard ratio (HR) was 0·85 (95% CI, 0·56-1·29) (p=0·44) while the HR for the PPA resulted in 42 and 39 (28%;95% CI, 0·20-0·35) recurrences in the selenium and placebo group (HR = 0·96 (95% CI, 0·62-1·48) (p=0·93).
Conclusion: Selenium supplementation does not seem to lower the probability of recurrence in BC patients.
Clinical Data Manager (DM) Maastricht, Netherlands
Since September 2008
Background: In 2012, more than 400,000 urinary bladder cancer cases occurred worldwide, making it the 7th most common type of cancer. Although many previous studies focused on the relationship between diet and bladder cancer, the evidence related to specific food items or nutrients that could be involved in the development of bladder cancer remains inconclusive. Dietary components can either be, or be activated into, potential carcinogens through metabolism, or act to prevent carcinogen damage.
Methods/design: The BLadder cancer, Epidemiology and Nutritional Determinants (BLEND) study was set up with the purpose of collecting individual patient data from observational studies on diet and bladder cancer. In total, data from 11,261 bladder cancer cases and 675,532 non-cases from 18 case–control and 6 cohort studies from all over the world were included with the aim to investigate the association between individual food items, nutrients and dietary patterns and risk of developing bladder cancer.
Discussion: The substantial number of cases included in this study will enable us to provide evidence with large statistical power, for dietary recommendations on the prevention of bladder cancer.
AdaptabilityAnalytical thinkingAssertivenessAttention to detailAuthenticityCollaborationCommunicativeCoordinationCreative thinkingCritical thinkingCuriosityEfficiencyIndependenceInterest in knowledgeOrganizationProblem solvingResponsibilitySelf-disciplineSelf-confidenceStrategic thinkingWillingness to compromise
Biostatistics R&D Scientific writingAdverse Events (AE)AnalysisBiomedical SciencesCancerCancer ResearchClinical Study DesignClinical researchClinical trial managementClinical trialsCommunication SkillsCRFData AnalysisData cleaningData entryData ManagementDatabaseseCRFEnglishEpidemiologyFamily practiceGeneral MedicineGeneral practiceGood Clinical Practice (GCP)HealthcareInformed Consent DocumentsmanagementManaging Clinical Trial SuppliesMedical writingMedical oncology MedicineMicrosoft ExcelMicrosoft OfficeMicrosoft PowerpointMicrosoft WordNutritionPatient recruitmentPhase IIIPresentation SkillsRandomization and blindingResearchScientific WritingSearch literature on clinical trialsSerious Adverse Event (SAE)Social SkillsStatisticsStatistical Data AnalysisStudy proposalsUrologyWriting Study Procedures and SOPs
Skills and Expertise
Analyze data Create SOPs Design case record forms Develop clinical trial protocols Develop protocols Guide students Interact with physicians Interact with nurses Control data Interpret data Monitor a clinical study Report data Search literature on clinical trials Write papers Write protocolsAdverse event reportingAssess adverse reactionsAssemble regulatory applicationsAssist study siteAssist with proceduresAttend investigator meetingClinical data collectionCollaborate with medical teamcollaborate in research projects at universitiesCollaborate with principal investigatorCollaborate with project teamCollect dataCollect patient forms and questionnairesCommunicationComplete case report form (CRF)Conduct limited data and/or statistical analysis.Conduct literature searchesConduct research at universitiesConduct studiesConduct university research Control studiesCoordinationCreate clinical documentsCreate SOPsCreate standard operating procedure (SOP)Create study documentsData codingData entryData miningData verificationDesign case record form (CRF)Design clinical trialDesign data collection systemsDesign database Design exclusion criteriaDesign inclusion criteriaDesign information leafletDesign protocolDesign studyDesign study documentsDesign subject consent formDesign trial master file (TMF)Determine statistical analysis Develop protocolsEnsure good clinical practice (GCP)Establish professional relationships with partnersEthics committee applicationEthics committee submissionsGuide studentsInformed consent processInitiate clinical trials Interact with ethics committeeInteract with nursesInteract with physiciansInteract with statisticiansInterpret analytical resultsInterpret dataInterpret research resultsInterpret scientific dataLead studiesLiaise with doctors and other professionals throughout the studyLiaise with doctorsManage clinical suppliesManage clinical trial files/documentsManage data collection systemManage trial master file (TMF)Oral presentationOrganise meetingsPresent clinical resultsPresent data at congressProtocol managementPublication of articlesPublish scientific projectsRead medical literatureReport serious adverse events (SAE)Report study conclusionsResearch at universitiesReview dataSearch literature on clinical trialsSolve problemsStatistical analysisSubmit regulatory applicationsWrite final reportsWrite documentsWrite medical reportsWrite papersWritten presentation
Ph.D in Medicine from KU Leuven in 2017
Master in Medicine from KU Leuven in 1990
Training and Certification
• Introduction to Genetic Epidemiology and complex genetics in large human populations by Maurice Zeegers in 2012 Training
• Clinical Trial Statistics for non-statisticians in 2011 Training
• Design and Analysis of Clinical Trials by Dave Harrington in 2011 Training
• Multilevel Analysis for grouped and longitudinal data by Leoniek Wijngaards-deMeij in 2011 Training
• Multiple Testing for Genomic Data in 2011 Training
• Interactive GCP-workshop for Experienced Researchers, the EU Clinical Trial Directive and its Implications on your clinical research practice in 2013 Certification
• Introduction to linear and logistic Regression models organised by the School of Social and Community Medicine in 2012 Certification
• Introduction to Stata for survival analysis and Statistical methods for Population Based Cancer Survival analysis by Paul Dickman in 2012 Certification
Presentation and seminar skills for biomedical researches by Linda Vekemans in 2012 Certification
• Statistics and Applied Biostatistics by Emmanuel Lesaffre, Geert Verbeke and Geert Molenberghs in 2009 Certification
Training for clinical investigator (eCLIN) in 2006 Certification
Training General Practitioner-Researcher in 2005 Certification
Expert has 4 publications (Will be avalible with full profile)