Inefficiencies in phase II to phase III transition impeding successful drug development in glioblastoma.

ABSTRACT:

Background

Improving outcomes of patients with glioblastoma (GBM) represents a significant challenge in neuro-oncology. We undertook a systematic review of key parameters of phase II and III trials in GBM to identify and quantify the impact of trial design on this phenomenon.

Methods

Studies between 2005 and 2019 inclusive were identified though MEDLINE search and manual bibliography searches. Phase II studies (P2T) were restricted to those referenced by the corresponding phase III trials (P3T). Clinical and statistical characteristics were extracted. For each P3T, corresponding P2T data was "optimally matched," where same drug was used in similar schedule and similar population; "suboptimally matched" if dis-similar schedule and/or treatment setting; or "lacking." Phase II/

SUBMITTER: Balasubramanian A 

PROVIDER: S-EPMC7850118 | biostudies-literature | 2021 Jan-Dec

REPOSITORIES: biostudies-literature