title: Why balls are not put inside the basket? A reflection on testicular cancer clinical trial design.
abstract: New concepts of trial design are being developed based on biomarkers, namely basket and umbrella trials. Basket trials appear optimally positioned to evaluate new molecular markers for testicular germ cell tumors, a rare heterogeneous disease with relatively few molecular alterations. However, not uncommonly, the "balls" fall outside the "basket". In this short communication, we discussed the different causes limiting the inclusion of TGCT in basket trials and we proposed a new design for trials suitable for this malignancy.
authors.affiliation: Jules Bordet Institute, Brussels, Belgium. hampig.kourie@hotmail.com.|Free University of Brussels, Belgium, Brussels, Belgium. hampig.kourie@hotmail.com.
authors.forename: Hampig Raphael
authors.initials: HR
authors.lastname: Kourie
authors.affiliation: Jules Bordet Institute, Brussels, Belgium.|Free University of Brussels, Belgium, Brussels, Belgium.
authors.forename: Fouad
authors.initials: F
authors.lastname: Aoun
mesh_terms: D015415:Biomarkers; D002986:Clinical Trials as Topic; D006801:Humans; D008297:Male; D009373:Neoplasms, Germ Cell and Embryonal / Q000188:drug therapy*; D013736:Testicular Neoplasms / Q000188:drug therapy*
chemical_list: D015415:Biomarkers
keywords: Basket trial; Design; Testicular germ cell tumors; Trial