%0 Journal Article %1 Porcher2011 %A Porcher, Raphaël %A Lecocq, Brigitte %A Vray, Muriel %A D’Andon, Anne %A Bassompierre, François %A Béhier, Jean-Michel %A Belorgey, Chantal %A Bénichou, Jacques %A Berdeaux, Gilles %A Bergougnoux, Loic %A Bilbault, Pascal %A Chassany, Olivier %A Brentano, Christian Funck %A Gersberg, Martha %A Labreveux, Claire %A Lassale, Catherine %A Lebbé, Céleste %A Lecocq, Brigitte %A Lévy, Vincent %A Montestruc, François %A Morgan, Caroline %A Nachbaur, Gaelle %A Palestro, Brigitte %A Paoletti, Xavier %A Porcher, Raphaël %A Raison, Anne %A Spiess, Laurent %A Strub, Nathalie %A Vitzling, Christian %A Vray, Muriel %D 2011 %J Thérapie %K BayesTheorem ClinicalTrials ClinicalTrialsDataMonitoringCommittees ClinicalTrialsasTopic ClinicalTrialsasTopic:methods ClinicalTrialsasTopic:statistics&numericald DataInterpretation OrganizationandAdministration PhaseIIasTopic PhaseIasTopic PhaseIasTopic:methods PhaseIasTopic:statistics&numericaldata ResearchDesign ResearchDesign:statistics&numericaldata SampleSize Statistical %N 4 %P 309-317 %R 10.2515/therapie/2011042 %T Les méthodes adaptatives : quand et comment les utiliser dans les essais cliniques ? %U http://www.ncbi.nlm.nih.gov/pubmed/21851793 http://linkinghub.elsevier.com/retrieve/pii/S0040595716307788 %V 66 %X Adaptive clinical trial designs are defined as designs that use data cumulated during trial to possibly modify certain aspects without compromising the validity and integrity of the said trial. Compared to more traditional trials, in theory, adaptive designs allow the same information to be generated but in a more efficient manner. The advantages and limits of this type of design together with the weight of the constraints, in particular of a logistic nature, that their use implies, differ depending on whether the trial is exploratory or confirmatory with a view to registration. One of the key elements ensuring trial integrity is the involvement of an independent committee to determine adaptations in terms of experimental design during the study. Adaptive methods for clinical trials are appealing and may be accepted by the relevant authorities. However, the constraints that they impose must be determined well in advance.

@article{Porcher2011, abstract = {Adaptive clinical trial designs are defined as designs that use data cumulated during trial to possibly modify certain aspects without compromising the validity and integrity of the said trial. Compared to more traditional trials, in theory, adaptive designs allow the same information to be generated but in a more efficient manner. The advantages and limits of this type of design together with the weight of the constraints, in particular of a logistic nature, that their use implies, differ depending on whether the trial is exploratory or confirmatory with a view to registration. One of the key elements ensuring trial integrity is the involvement of an independent committee to determine adaptations in terms of experimental design during the study. Adaptive methods for clinical trials are appealing and may be accepted by the relevant authorities. However, the constraints that they impose must be determined well in advance.}, added-at = {2023-02-03T11:44:35.000+0100}, author = {Porcher, Raphaël and Lecocq, Brigitte and Vray, Muriel and D’Andon, Anne and Bassompierre, François and Béhier, Jean-Michel and Belorgey, Chantal and Bénichou, Jacques and Berdeaux, Gilles and Bergougnoux, Loic and Bilbault, Pascal and Chassany, Olivier and Brentano, Christian Funck and Gersberg, Martha and Labreveux, Claire and Lassale, Catherine and Lebbé, Céleste and Lecocq, Brigitte and Lévy, Vincent and Montestruc, François and Morgan, Caroline and Nachbaur, Gaelle and Palestro, Brigitte and Paoletti, Xavier and Porcher, Raphaël and Raison, Anne and Spiess, Laurent and Strub, Nathalie and Vitzling, Christian and Vray, Muriel}, biburl = {https://www.bibsonomy.org/bibtex/2f638c2a59be2467a2357f56eb2330450/jepcastel}, doi = {10.2515/therapie/2011042}, interhash = {9626e9ba71fe373515a69b5ba1b703cd}, intrahash = {f638c2a59be2467a2357f56eb2330450}, issn = {00405957}, journal = {Thérapie}, keywords = {BayesTheorem ClinicalTrials ClinicalTrialsDataMonitoringCommittees ClinicalTrialsasTopic ClinicalTrialsasTopic:methods ClinicalTrialsasTopic:statistics&numericald DataInterpretation OrganizationandAdministration PhaseIIasTopic PhaseIasTopic PhaseIasTopic:methods PhaseIasTopic:statistics&numericaldata ResearchDesign ResearchDesign:statistics&numericaldata SampleSize Statistical}, month = {7}, note = {Tipus d'estudis; Dissenys adaptatius; RCT; Introductori}, number = 4, pages = {309-317}, pmid = {21851793}, timestamp = {2023-02-03T11:44:35.000+0100}, title = {Les méthodes adaptatives : quand et comment les utiliser dans les essais cliniques ?}, url = {http://www.ncbi.nlm.nih.gov/pubmed/21851793 http://linkinghub.elsevier.com/retrieve/pii/S0040595716307788}, volume = 66, year = 2011 }