Mancolepanto
02/01/25 21:22
Ha respondido al tema Laminar Pharmaceuticals
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Copio directamente de la descripción del estudio en ClinicalTrials:After 45 events for PFS are observed, a formal interim analysis will be performed and the data reviewed by an Independent Data Monitoring Committee (IDMC) or may be activated by the IDMC 12 months after the inclusion of the last patient if follow up is sufficient to identify an overall PFS or OS significant deviation from the literature. After reviewing the interim results, the iDMC will make recommendations regarding: the sample size and the continuation of the trial overall.Further, the sample size and events will be re-estimated to ensure that the statistical power is maintained given the estimated treatment effect at interim analysis. The events/sample size increase will be based on the considerations of the success probability.For that purpose, based on the conditional power, the interim results will be classified into the following zones: favourable, unfavourable or promising.If the interim results fall in the promising zone, then it is planned to increase the total number of events both for PFS and OS by up to 50%, with up to 99 events for PFS and up to 135 events for OS. The total sample size will also be increased to up to 210 patients to ensure the desired number of events within a realistic time. If the interim results are favourable or unfavourable, the study size will remain as initially planned with 66 events for PFS and 90 for OS, collected from 140 patients.The IDMC committee experts met in February 2024 after 45 PFS events occurred in the trial. Unblinded medical and clinical statistical data from 103 patients were evaluated to assess the efficacy - progression free survival (tumour growth or clinical deterioration) - of LAM561. The IDMC confirmed that, at the current level of evidence, after evaluating the Conditional Power of the unblinded results, no futility has been identified and recommends continuation of the study without modification.https://clinicaltrials.gov/study/NCT04250922?lead=Laminar%20Pharmaceuticals&rank=2A mí me parece muy fuerte que en 66 eventos hayamos caído en no significación estadística cuando Pablo escribió un correo diciendo que "los resultados podrían ser buenos, muy buenos o excelentes, en base a los comentarios preliminares del Comité".Además tras 45 eventos en la lectura del comité había 3 opciones de decisión (en realidad cuatro):- Aumentar 50% muestra si caíamos en zona prometedora.- Detener el ensayo.- Continuar sin modificaciones si la lectura interina era favorable.- Continuar sin modificaciones si la lectura interina era desfavorable.Todos entendimos que manteníamos el ensayo sin modificaciones porque no había futilidad y la lectura interina era favorable.¿Alguien puede dar una respuesta a esto?