Dose reduction studies: how much of the treatment effect is lost?

Datum dogodka: 
četrtek, 14. marec 2024 - 11:00
Lokacija predavanja: 
sejna soba UL MF
Predavatelj: 
prof. dr. John O'Quigley

A recent FDA report called Project Optimus states that "poorly characterized dose and schedule may lead to selection of a dose that provides more toxicity without additional efficacy, severe toxicities that require a high rate of dose reductions, intolerable toxicities that lead to premature discontinuation and missed opportunity for continued benefit from the drug, and potentially persistent or irreversible toxicities that limit the options for receiving benefit of subsequent therapies". The FDA found that 15% of all oncology drugs approved from 2010 to 2022 required a post-marketing requirement to investigate alternative dosing and improve the risk:benefit profile of the drug. One of the headings of Project Optimus relates to the impact of a reduced dose on outcome. That is our focus in this presentation. We consider a completed Phase 3 trial and ask the question: how much of the treatment effect is sacrificed by a dose reduction?   

Na kratko o IBMI

Inštitut za biostatistiko in medicinsko informatiko (IBMI), prej Inštitut za biomedicinsko informatiko (torej tudi IBMI), je Medicinska fakulteta ustanovila leta 1973 kot izraz potrebe po izvajanju in usklajevanju del, vezanih na analizo podatkov in posredovanje informacij. Program dela in razvoja se je skozi čas prilagajal predvsem spremembam pri financiranju in tehnološkemu napredku, vendar so temeljne smernice ostale enake: inštitut se predvsem posveča dejavnostim, ki so pomembne za raziskovalno delo v medicini. Te pa lahko razdelimo na:

Kontakt

Inštitut za biostatistiko in medicinsko informatiko
Medicinska fakulteta
Univerza v Ljubljani
Vrazov trg 2, 1000 Ljubljana, Slovenija

tel: (01) 543-77-70
fax: (01) 543-77-71
email: ibmi (at) mf.uni-lj.si