The Clinical Proof of Concept landscape
The Oncode Exploratory Development Expert Support (OEDES) team provides guidance and advice when it comes to translating our fundamental scientific insights into new diagnostics and therapeutic strategies. In this video series the OEDES members will take you on an informative journey, through the landscape of Clinical Proof of Concept. Especially if you are looking for an introduction to Clinical Research, Pre-clinical requirements or the development of a biomarker or biomarker assay, you will find your answers here. Also, if you are interested in hearing more about Clinical Proof-of-Concept in Oncology, the Predictive Value or how to define a Target Product Profile, you have come to the right place.
Introduction to Clinical Research
In this introduction to (exploratory) clinical research OEDES Member Paul de Koning gives us insights into the history of clinical research, and how issues in the areas of safety, ethics and quality have shaped regulations. The module explains the causes of low and declining probability of success in pharmaceutical research & development and continues with what we can do about this low probability. In conclusion: this module is a must see for everyone that likes to learn more about the change in clinical research over time, the important aspect of probability of success or how OEDES might help you.
This module focuses on the framework of conceptual and analytical validation required for the development of a biomarker or a biomarker assay. The important principle ‘context of use’ and the five steps of the evidentiary criteria for regulatory acceptance of a biomarker/assay are explained by OEDES member Danny Burg. The different biomarker categories and elements for a fit-for-purpose biomarker method validation are illustrated with some interesting figures.
In the predictive value module OEDES member Ellen Hulskotte discusses the main types of biomarkers and talks about the validity of a biomarker or biotest. Also of interest are the different quality markers: sensitivity, specificity, positive predictive value and the negative predictive value. In other words: this module tries to answer the question when a test is good enough to be trusted and used in clinical practice.
Defining a Target Product Profile
How good should your product be? How to find the areas of unmet need for a medicine, biomarker or diagnostic test? OEDES member Paul de Koning gives an answer to the questions you might be running into in the process of creating a new product. This module gives us an overview of the full development and more important: it reminds us to start with the goal in mind.
Clinical Proof-Of-Concept in Oncology
Do you know what the go/no go decision criteria are to proceed to phase III clinical trials? By using examples OEDES member Ellen Hulskotte demonstrates the specific criteria for a new drug and diagnostic. In the module about the target product profile, Paul de Koning made a start with the critical product attributes. Now, Ellen discusses how to use these critical compound attributes to design a Proof of Concept study as well as go / no go criteria. The criteria should be such that if they are met, they provide sufficient confidence to invest in expensive late phase 2 or 3. Lastly, the module identifies several surrogate endpoints and other aspects for a PoC trial (design, patient population, sample size and dose and formulation).
In light of the pre-clinical requirements we have another regulatory framework we’d liked you to know of and OEDES member Danny Burg discusses three different scenarios that you might encounter in the future: a new oncology indication for an existing (approved) drug, a new drug combination and a new oncology therapeutic. This module is especially very helpful when you want to review pre-clinical requirements for testing a new drug-based therapy in humans.
Do you have any remaining questions after seeing the educational materials from above? Please reach out to Marlinde Smit. Please have a look at our Clinical Proof of Concept programme to learn more about the opportunities within Oncode.