Challenges And Setbacks

While progress in biomarker R&D has accelerated, the clinical translation of disease biomarkers as endpoints in disease management and as the foundation for diagnostic products has had more extensive challenges [30] . For example, we have not observed a large number of surrogate endpoints emerging as clinical trial decision points. Notable exceptions to this include imaging endpoints that have grown in substantial numbers. In most cases for drug development, biomarkers are being applied in therapeutic development to stratify patients into subgroups of responders, to aid in pharmacodynamic assessment, and to identify early toxicity indicators to avoid late-stage failures in therapeutic development.

There are difficulties in aligning the biomarker science to clinical outcome parameters to establish the clinical value in medical practice decision making. As applied in clinical practice, biomarkers have their most anticipated applications in pharmacotherapeutic decisions in treatment selection and dosing, risk assessment, and stratification of populations for disease preemption and prevention. In the United States, challenges to the marketplace are presented by the lack of extensive experience with pathways for medical product review and reimbursement systems that establish financial incentives for biomarker development as diagnostic assays. Clinical practice guidelines for biomarker application in many diseases are lacking, leaving clinicians uncertain about what roles biomarker assays play in disease management. In addition, few studies have been done to evaluate the cost-effectiveness of inclusion of bio-markers and molecular diagnostics in disease management [31] . The lack of these key pieces in a system of modern health care can cripple plans for integration of valuable technologies into clinical practice.

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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