[ABE-L] Seminário conjunto UFSCar/USP - 14/08/2020 às 14h00

[PIPGEs UFSCar]

Prezados (as), muito bom dia!

Espero que estejam todos bem. Conforme solicitado pelo Prof. Sandro Gallo,
venho por meio deste convidá-los para o seminário desta sexta-feira (14/08):

*Seminário Conjunto UFSCar/USP*

*Data e Horário:*

14/08/2020 às 14h

*Local:*

Google Meet - meet.google.com/mho-xyta-gky
<https://meet.google.com/mho-xyta-gky?hs=122&authuser=0>

*Título:*

Comparison of inferential seamless phase II/III designs for acute stroke
trials with biomarkers as surrogate endpoints

*Palestrante:*

Márcio Augusto Diniz (Cedars-Sinai)

*Resumo:*

Inferential seamless phase II/III designs have been proposed as an
alternative path to
traditional drug development in order to decrease failure in large phase
III trials. Seamless phase II/III
designs allow investigators to accommodate randomized phase II designs that
require larger samples
sizes instead of single-arm designs that depend on historical data with
often different case-mix
populations. Response adaptive randomization (RAR) is often implemented
aiming to allocate more
subjects to the apparently superior arm, stop the lead-in phase early for
efficacy, drop a poorly
performing arm, and thus, may resulting in more patients being treated
successfully. However, RAR
algorithms require a short-term response relative to the accrual rate,
otherwise, allocation probabilities
will not be updated sufficiently quick such that patients could be
benefited. Several authors have
proposed the use of biomarkers as a surrogate for a long-term endpoint when
calculating allocation
probabilities without considering their diagnostic performance. In this
work, we study the loss in power,
type I error and trial duration for an acute stroke trial with a long-term
ordinal endpoint as function of
sensitivity and specificity for biomarkers that are used as surrogate when
calculating allocation
probabilities and/or stopping rules.

*Autores:* Márcio Augusto Diniz, Patrick Lyden and Mourad Tighiouart -
Cedars-Sinai Medical Center

Contamos com a presença de todos!

Lembramos também que todos os seminários e outras atividades previstas
encontram-se na página do PIPGEs http://www.pipges.ufscar.br/

Atenciosamente,

-------
Julio Cezar de Barros
Assistente em Administração
PIPGEs-UFSCar
-------------- Próxima Parte ----------
Um anexo em HTML foi limpo...
URL: <https://lists.ime.usp.br/archives/abe/attachments/20200813/6394ab80/attachment-0001.html>