Consensus Method

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Lincoln L Berland - One of the best experts on this subject based on the ideXlab platform.

Sunit Sebastian - One of the best experts on this subject based on the ideXlab platform.

Tienhan Sandrine Dabakuyo - One of the best experts on this subject based on the ideXlab platform.

  • 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
    Annals of Oncology, 2015
    Co-Authors: C Bellera, Nicolas Penel, M Ouali, S Bonvalot, Paolo G Casali, O S Nielsen, M Delannes, Saskia Litiere, F Bonnetain, Tienhan Sandrine Dabakuyo
    Abstract:

    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.

  • protocol of the definition for the assessment of time to event endpoints in cancer trials datecan project formal Consensus Method for the development of guidelines for standardised time to event endpoints definitions in cancer clinical trials
    European Journal of Cancer, 2013
    Co-Authors: C Bellera, M Ouali, Tienhan Sandrine Dabakuyo, A Kramar, Marina Pulido, Sophie Gourgou, Laurence Collette, Adelaide Doussau, Anne Auperin, Thomas Filleron
    Abstract:

    Abstract Introduction In randomised phase III cancer clinical trials, the most objectively defined and only validated time-to-event endpoint is overall survival (OS). The appearance of new types of treatments and the multiplication of lines of treatment have resulted in the use of surrogate endpoints for overall survival such as progression-free survival (PFS), or time-to-treatment failure. Their development is strongly influenced by the necessity of reducing clinical trial duration, cost and number of patients. However, while these endpoints are frequently used, they are often poorly defined and definitions can differ between trials which may limit their use as primary endpoints. Moreover, this variability of definitions can impact on the trial’s results by affecting estimation of treatments’ effects. The aim of the Definition for the Assessment of Time-to-event Endpoints in CANcer trials (DATECAN) project is to provide recommendations for standardised definitions of time-to-event endpoints in randomised cancer clinical trials. Methods We will use a formal Consensus Methodology based on experts’ opinions which will be obtained in a systematic manner. Results Definitions will be independently developed for several cancer sites, including pancreatic, breast, head and neck and colon cancer, as well as sarcomas and gastrointestinal stromal tumours (GISTs). Discussion The DATECAN project should lead to the elaboration of recommendations that can then be used as guidelines by researchers participating in clinical trials. This process should lead to a standardisation of the definitions of commonly used time-to-event endpoints, enabling appropriate comparisons of future trials’ results.

C Bellera - One of the best experts on this subject based on the ideXlab platform.

  • 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
    Annals of Oncology, 2015
    Co-Authors: C Bellera, Nicolas Penel, M Ouali, S Bonvalot, Paolo G Casali, O S Nielsen, M Delannes, Saskia Litiere, F Bonnetain, Tienhan Sandrine Dabakuyo
    Abstract:

    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.

  • protocol of the definition for the assessment of time to event endpoints in cancer trials datecan project formal Consensus Method for the development of guidelines for standardised time to event endpoints definitions in cancer clinical trials
    European Journal of Cancer, 2013
    Co-Authors: C Bellera, M Ouali, Tienhan Sandrine Dabakuyo, A Kramar, Marina Pulido, Sophie Gourgou, Laurence Collette, Adelaide Doussau, Anne Auperin, Thomas Filleron
    Abstract:

    Abstract Introduction In randomised phase III cancer clinical trials, the most objectively defined and only validated time-to-event endpoint is overall survival (OS). The appearance of new types of treatments and the multiplication of lines of treatment have resulted in the use of surrogate endpoints for overall survival such as progression-free survival (PFS), or time-to-treatment failure. Their development is strongly influenced by the necessity of reducing clinical trial duration, cost and number of patients. However, while these endpoints are frequently used, they are often poorly defined and definitions can differ between trials which may limit their use as primary endpoints. Moreover, this variability of definitions can impact on the trial’s results by affecting estimation of treatments’ effects. The aim of the Definition for the Assessment of Time-to-event Endpoints in CANcer trials (DATECAN) project is to provide recommendations for standardised definitions of time-to-event endpoints in randomised cancer clinical trials. Methods We will use a formal Consensus Methodology based on experts’ opinions which will be obtained in a systematic manner. Results Definitions will be independently developed for several cancer sites, including pancreatic, breast, head and neck and colon cancer, as well as sarcomas and gastrointestinal stromal tumours (GISTs). Discussion The DATECAN project should lead to the elaboration of recommendations that can then be used as guidelines by researchers participating in clinical trials. This process should lead to a standardisation of the definitions of commonly used time-to-event endpoints, enabling appropriate comparisons of future trials’ results.

Maitray D Patel - One of the best experts on this subject based on the ideXlab platform.

  • managing incidental findings on abdominal and pelvic ct and mri part 1 white paper of the acr incidental findings committee ii on adnexal findings
    Journal of The American College of Radiology, 2013
    Co-Authors: Maitray D Patel, Susan M Ascher, Raj Mohan Paspulati, Alampady Krishna Prasad Shanbhogue, Evan S Siegelman, Marjorie W Stein, Lincoln L Berland
    Abstract:

    This white paper describes adnexal (ovarian and paraovarian) incidental findings found on CT and MRI in nonpregnant postmenarchal patients in whom no adnexal disorder is clinically known or suspected. This represents the first of 4 such papers from the ACR Incidental Findings Committee II, which used a Consensus Method based on repeated reviews and revisions and a collective review and interpretation of relevant literature. Recommendations for the management of incidental adnexal findings are organized into 4 main categories: benign-appearing cysts, probably benign cysts, adnexal masses with characteristic features, and all other adnexal masses, with pathways on the basis of patient menstrual status or age (when last menstrual period is unknown). A table and flowchart are provided for reference.