CoDevelopment and Phase III Drug Studies

If a diagnostic is actually intended for use in patient selection, the safety and efficacy of the drug may in fact depend on the ability of the test to identify patients properly. Clinical trials for drug approval are generally multicenter. Therefore, during co -development the test needs to be standardized and a consensus methodology for test validation among the centers should be established. Ideally, analytical validation should be performed prior to phase

III trials, so that clinical validation can be established using an analytical robust test.

When the drug approval is contingent on use of the diagnostic, the diagnostic should optimally be studied either at the time of the original phase III study or in a follow-up phase III--ike study before drug approval can be obtained. These studies would most commonly be based on an appropriately designed and powered prospective blinded and randomized clinical trial usually associated with drug approvals and validated in follow-up trials. Co-development strategy timing is illustrated in Figure 3.

Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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