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)†.

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.

[Assessment of adherence to Afssaps guidelines for the prescription of antifungals in pediatric hemato-oncology]. / Évaluation de l'adhésion au référentiel Afssaps sur les antifongiques, en hémato-oncologie pédiatrique.

OBJECTIVE: This study had for aim to identify factors limiting the implementation of clinical guidelines related to the use of expensive antifungal drugs in pediatric hemato-oncology. DESIGN: A retrospective study was conducted in a Lyon teaching hospital (France), from February to December 2008. The compliance of antifungal prescription to French guidelines was assessed. Audit findings were interpreted using both semi-directed interviews of six prescribers (qualitative approach) and statistical analysis of prescriptions (quantitative approach). RESULTS: Fifty antifungal prescriptions were studied. The compliance with clinical guidelines reached 66% (CI 95% 52-80%). The semi-directed interviews revealed that five issues may have influenced the adherence of prescribers with recommended practices: the guidelines, the molecule, the prescriber, the child, and practice settings. The statistical analysis did not reveal any link between the prescriber's activities or his department and the compliance with guidelines. A significant association was found between the documentation of infection and the non-conformity of antifungal prescriptions (p=0.02). CONCLUSIONS: This study, combining qualitative and quantitative assessments, addressed potential issues related to the implementation of guidelines in specific patient groups or to their adaptation in the context of pediatric hematology-oncology. Harmonization of practices related to the widespread use of antifungal associations is required.

[Huriet law: application in a regional cancer centre (Centre Léon-Bérard, Lyon)]. / Loi Huriet: bilan d'application dans un centre régional de lutte contre le cancer (centre Léon-Bérard, Lyon).

Clinical research is one of the main activities in cancer centres and is submitted in France to a specific law (named "loi Huriet") which includes good clinical practices. We are now conducting a general program of quality evaluation and improvement in the regional cancer centre of Lyon (centre Léon-Bérard). Part of this program is an audit of the application of the Huriet law. Since no instrument exist for measuring this application, we have created a specific one, that attribute notation according to the different aspects of the law. Results show a good level of conformity but sometime non sufficient. There is no difference between the two studied years. Quality changes according to promoters (private or academic) and monitoring. Written procedures and specific training for the different actors are required to improve quality of clinical research with focus on the patient interest.