An efficient randomised trial design for multi-cancer screening blood tests: nested enhanced mortality outcomes of screening trial.

Abstract

Screening aims to detect cancer at an early, curable stage, and is currently recommended for breast, lung, colorectal, and cervical cancers in some countries. Prostate cancer screening might be considered for some men. Individual screening programmes for most other cancer types are unlikely to be worthwhile, mainly because each of these cancers has relatively low incidence and mortality. Leveraging external data in the design and analysis of clinical trials in neuro-oncologyIntegration of external control data, with patient-level information, in clinical trials has the potential to accelerate the development of new treatments in neuro-oncology by contextualising single-arm studies and improving decision making (eg, early stopping decisions). Based on a series of presentations at the 2020 Clinical Trials Think Tank hosted by the Society of Neuro-Oncology, we provide an overview on the use of external control data representative of the standard of care in the design and analysis of clinical trials. Full-Text PDF Basket clinical trial design for targeted therapies for cancer: a French National Authority for Health statement for health technology assessmentDuring the past decade, health technology assessment bodies have faced new challenges in establishing the benefits of new drugs for individuals and health-care systems. A topic of increasing importance to the field of oncology is the so-called agnostic regulatory approval of targeted therapies for cancer (independent of tumour location and histology) granted on the basis of basket trials. Basket trials in oncology offer the advantage of simultaneously evaluating treatments for multiple tumours, even rare cancers, in a single clinical trial. Full-Text PDF Guidelines for cellular and molecular pathology content in clinical trial protocols: the SPIRIT-Path extensionThe 2013 SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) Statement provides evidence-based recommendations for the minimum content to be included in a clinical trial protocol. Assessment of biospecimens is often required for trial eligibility or as part of an outcome evaluation, and precision molecular approaches are increasingly used in trial design. However, cellular and molecular pathology practices within trials have not been codified or formalised. We developed international consensus reporting guidelines for cellular and molecular pathology content in clinical trial protocols (the SPIRIT-Path extension) using an international Delphi process, which assesses candidate items generated from a previous systematic review, followed by an expert consensus meeting. Full-Text PDF Late phase 1 studies: concepts and outcomesOver the past two decades, targeted therapies have become cornerstone treatments for numerous cancers with oncogene addiction. Unfortunately, their effectiveness reduces over time and most patients who receive targeted therapies relapse within 12 months. The emergence of drug-resistance mechanisms in tumours paved the way for next-generation inhibitors. However, insufficient concentration of targeted therapy is a frequent but poorly explored mechanism of treatment failure. Additionally, the maximum tolerated dose (MTD) is not always reached in phase studies, and the recommended phase 2 dose is mostly based on benefit–risk ratio and pharmacokinetic considerations, which could result in a suboptimal dose. Full-Text PDF Correction to Lancet Oncol 2021; 22: 1360–62Hackshaw A, Berg CD. An efficient randomised trial design for multi-cancer screening blood tests: nested enhanced mortality outcomes of screening trial. Lancet Oncol 2021; 22: 1360–62—In this Comment the affiliation details for Christine D Berg have been updated. This correction has been made to the online version as of Nov 1, 2021. Full-Text PDF