Critical factors for successful early phase oncology trials – an analysis

Early phase trials have always been critical within pharmaceutical development, establishing the safety and potential efficacy of a new molecule or treatment with a view to further research and eventually access.

Within the oncology pipeline, this phase increasingly plays an even more essential role, due to incorporating both the preliminary evaluation of anti-tumour activity and the selection of the cancer population more likely to be targeted by the new drug.

To explore this situation and analyse potential best practice, QuintilesIMS brought together four of its industry thought leaders to author a new white paper: Oncology Phase 1 Trials:  a scientific and operational review, which gives an in-depth overview of this crucial stage of development as drugs and therapies are tested in humans for the first time.

Phase I studies are the bridge between basic science and clinical development, and this report outlines how early stage trials provide pivotal information to select the right drug, at the right dose, for the right patients, later in development.

The paper also describes the different type of Phase I studies, highlights the associated challenges to be managed, provides an analysis of the statistical considerations associated with different designs and summarises biomarker strategy requirements (PK/PD, exploratory biomarker analysis and early predictice biomarkers)

From an operational prospective, sites running Phase I trials must be able to work well together due to their nature and the strong collaboration and cooperation required across sites. Accordingly, early phase trials are best conducted through a network of tailored Early Clinical Development Oncology sites which are used to conduct studies together in this specialised area. This is the reason why QuintilesIMS has established an Early Phase Network (EPON) of sites to efficiently deliver these studies.

To access, view and download the full paper click here.