Misgivings have been raised about the operating characteristics of the canonical 3+ 3 dose-
escalation phase I clinical trial design. Yet, the traditional 3+ 3 design is still the most …

Background Early phase dose-finding (EPDF) trials are crucial for the development of a new
intervention and influence whether it should be investigated in further trials. Guidance exists …

Modern cancer therapeutics are increasingly targeted, bringing the promise of new and
improved activity, alongside better tolerability. However, while many are indeed resulting in …

Adaptive designs for clinical trials permit alterations to a study in response to accumulating
data in order to make trials more flexible, ethical, and efficient. These benefits are achieved …

The CONSORT (CONsolidated Standards Of Reporting Trials) 2010 statement is the
standard guideline for reporting completed randomised trials. The CONSORT Dose-finding …

While interest in the application of machine learning to improve healthcare has grown
tremendously in recent years, a number of barriers prevent deployment in medical practice …

Purpose: To report on the first-in-human phase I study of VIP152 (NCT02635672), a potent
and highly selective cyclin-dependent kinase 9 (CDK9) inhibitor. Patients and Methods …

Background Current rheumatoid arthritis therapies target immune inflammation and are
subject to ceiling effects. Seliciclib is an orally available cyclin-dependent kinase inhibitor …

SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 provides
guidance for clinical trial protocol writing. However, neither the original guidance nor its …

This paper reports guidelines for the content of statistical analysis plans for early phase
clinical trials, ensuring specification of the minimum reporting analysis requirements, by …