Cancers familiaux et cancers héréditaires - Institut Jules Bordet ...

RÉGLEMENTATIONClinical Study Methodology:Why Clinical studies lead toinconclusive dataGenevieve Decoster, Director, IT & GCP Consulting sprlGenevieve.decoster@skynet.beUnreliable data sources:– Unreliable data are those that cannot betrusted or are inaccurate. Common sourcesof unreliable data are the failure to recruitthe required number of patients to achievereliable results (e.g. insufficient power, toofew patients), inappropriate statistical methodsand misinterpretation of the study.– Poor study design, confusing protocols,use of too many assessment methods orinvalidated methods also induce a highproportion of unreliable data.– Case report forms with overcrowded pagesor inadequate instructions for completingthe data fields lead to many inconsistencies.– In multicenter studies, lack of coordinationbetween investigators, the sponsor, or anythird party involved in clinical trial processyields to misinterpretation of the studyrequirements.What to do:– A biostatistician must always be involvedin the development of a protocol and cansupport:1. the determination of the numberof patients2. the study design3. the identification of the datato be collected4. the definition of the populationto be in the intent-to-treat or per protocolanalysis5. the statistical analysis plan– The clinical study protocol must always besimple and consistent. Redundancies mustbe avoided.The study protocol must also berealistic and fall within the current standardsof medical practice. Eligibility criteriamust target existing patient populations,and methods of disease assessmentsmust be validated and availablein all participating investigational sites.– It is recommended that the followingexpertise be involved in the developmentof a protocol: (1) a disease specialist, (2) aproduct expert, (3) a clinical study methodologist,(4) a drug safety specialist, and(5) a biostatistician as well as a study coordinatorin multi-center studies.La survie et la qualité de vie de votre malade atteint d’un cancerpeuvent dépendre de traitements disponiblesdans les programmes de recherche:Contacts:Hôpital Erasme: Dr Thierry Velu: 02/555 41 93 – tvelu@ulb.ac.beBordet-Iris: Dr Tatiana Besse-Hammer: 02/541 31 48 – tatiana.besse-hammer@bordet.beJOURNAL DU RÉSEAU CANCER DE L’UNIVERSITÉ LIBRE DE BRUXELLES N°3 – SEPTEMBRE 200513ABORDET-IRIS — ERASME — WLLONIE — RESEAU CANCER