Whitepapers

Lung Cancer Clinical Trials with a Seamless Phase II/III Design

Lately, the conventional sequential model of cancer clinical research is being replaced by adaptive trial designs, in which separate trial phases may be combined in a single protocol, thus accelerating drug development, and optimizing the use of available resources. In this context, this systematic review aims to critically discuss the methodology and outcomes of lung cancer clinical trials with a seamless phase II/III design. ​

​Find out more about adaptive trial designs in Optimapharm expert Dionysios Palermos article published in the Journal of Clinical Medicine! ​

CC: Lung Cancer Clinical Trials with a Seamless Phase II/III Design: Systematic Review, Journal of Clinical Medicine, Dec 2, 2022, Link to article: https://www.mdpi.com/2077-0383/11/23/7176 ​

How does an innovative clinical trial revolutionize the treatment of women with PCOS?

The SPIOMET4Health project is a clinical trial specifically designed to reshape PCOS treatment. Optimapharm is one of the partners on this project. SPIOMET stands for a combination of three medications: pioglitazone (PIO), metformin (MET), and spironolactone (SPI).

A scientific paper co-authored by Juan Vicente Torres, Optimapharm’s Vice President of Biostatistics Services, provides more information about this ongoing phase II clinical trial involving a randomized, double-blind, placebo-controlled study.

CC: Garcia-Beltran C, Malpique R, Andersen MS, Bas F, Bassols J, Darendeliler F, Díaz M, Dieris B, Fanelli F, Fröhlich-Reiterer E, Gambineri A, Glintborg D, López-Bermejo A, Mann C, Marin S, Obermayer-Pietsch B, Ødegård R, Ravn P, Reinehr T, Renzulli M, Salvador C, Singer V, Vanky E, Torres JV, Yildiz M, de Zegher F, Ibáñez L. SPIOMET4HEALTH-efficacy, tolerability and safety of lifestyle intervention plus a fixed dose combination of spironolactone, pioglitazone and metformin (SPIOMET) for adolescent girls and young women with polycystic ovary syndrome: study protocol for a multicentre, randomised, double-blind, placebo-controlled, four-arm, parallel-group, phase II clinical trial. Trials. 2023 Sep 15;24(1):589. doi: 10.1186/s13063-023-07593-6. PMID: 37715279; PMCID: PMC10503102.​ Link to article: https://pubmed.ncbi.nlm.nih.gov/37715279/