6533b82afe1ef96bd128c2af
RESEARCH PRODUCT
Guidelines for time-to-event end point definitions in sarcomas and gastrointestinal stromal tumors (GIST) trials: results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials)
Shreyaskumar PatelCarine BelleraHans GelderblomM. DelannesRobert J. GrimerChandrajit P. RautSophie Piperno-neumannOdile OberlinChiara MussiRolf D. IsselsBinh BuiJ.-y. BlayM. Van GlabbekeM. OualiAntoine ItalianoAlessandro GronchiO.s. NielsenE. StoecklePeter HohenbergerSimone Mathoulin-pélissierStefan SleijferNicolas PenelRick L. HaasSuzanne GeorgeC. Le PechouxI.l. Ray-coquardM. FioreS. BonvalotFlorence DuffaudRobert S. BenjaminF. BonnetainV. JoostePascale GrosclaudeThomas FilleronScott M. SchuetzePiotr RutkowskiF. CollinAnders Krarup-hansenPenella J. WollSophie Gourgou-bourgadeThomas F. DelaneyPaolo G. CasaliTienhan Sandrine DabakuyoSaskia Litièresubject
medicine.medical_specialtyConsensusTime FactorssarcomaDelphi TechniqueEndpoint Determination[SDV]Life Sciences [q-bio]Disease-Free Survivallaw.invention03 medical and health sciencesgastrointestinal stromal tumors0302 clinical medicineRandomized controlled trialSDG 3 - Good Health and Well-beinglawMultidisciplinary approachTerminology as TopicmedicineHumansMedical physicsTreatment Failureguidelinestime-to-event end pointComputingMilieux_MISCELLANEOUSRandomized Controlled Trials as Topic030304 developmental biologyEvent (probability theory)0303 health sciencesEnd pointGiSTSurrogate endpointbusiness.industryefficacy measureCancerHematologymedicine.disease3. Good healthOncologyResearch Design030220 oncology & carcinogenesisrandomized controlled trialDisease ProgressionRadiologySarcomabusinessdescription
ABSTRACT The DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials) aims to provide recommendations for definitions of time-to-event end points in cancer randomized controlled trials. We relied on a consensus method based on a multidisciplinary panel of experts to develop these guidelines for trials on sarcomas and gastrointestinal stromal tumors. Background The use of potential surrogate end points for overall survival, such as disease-free survival (DFS) or time-to-treatment failure (TTF) is increasingly common in randomized controlled trials (RCTs) in cancer. However, the definition of time-to-event (TTE) end points is rarely precise and lacks uniformity across trials. End point definition can impact trial results by affecting estimation of treatment effect and statistical power. The DATECAN initiative (Definition for the Assessment of Time-to-event End points in CANcer trials) aims to provide recommendations for definitions of TTE end points. We report guidelines for RCT in sarcomas and gastrointestinal stromal tumors (GIST). Methods We first carried out a literature review to identify TTE end points (primary or secondary) reported in publications of RCT. An international multidisciplinary panel of experts proposed recommendations for the definitions of these end points. Recommendations were developed through a validated consensus method formalizing the degree of agreement among experts. Results Recommended guidelines for the definition of TTE end points commonly used in RCT for sarcomas and GIST are provided for adjuvant and metastatic settings, including DFS, TTF, time to progression and others. Conclusion Use of standardized definitions should facilitate comparison of trials' results, and improve the quality of trial design and reporting. These guidelines could be of particular interest to research scientists involved in the design, conduct, reporting or assessment of RCT such as investigators, statisticians, reviewers, editors or regulatory authorities.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2015-05-31 |