Looking Forward

Scientific setbacks have also occurred across the frontier of discovery and development. Among notable instances was the use of pattern recognition of tandem mass spectrometric measurements of blood specimens in ovarian cancer patients. After enthusiastic support of the application in clinical settings, early successes were erased when technical errors and study design issues led to faulty assumptions about the findings. Across clinical development areas, deficiencies in clinical study design have left initial study findings unconfirmed, often due to overfitting of sample size to populations, and improper control for selection and design bias [32].

Commercial development of large-scale biology companies has also struggled in some ways to identify workable commercial models. Initial enthusiasm early in the decade about private marketing of genomic studies in disease models faltered as public data resources emerged. Corporate models for developing large proteomic databases faltered based on a lack of distinguished market value, little documented clinical benefit, and wide variability in quality of clinical biospecimens.

Evidence development to support clinical utility of many biomarkers to be used as clinical diagnostics is difficult to establish, as clinical trial infrastructure has not yet been established to validate candidate biomarkers for clinical practice. An obstacle to this has been access to well-characterized biospeci-mens coupled with clinical phenotype information. This has led to calls for centralized approaches to biospecimen collection and archiving to support molecular analysis and biomarker research [33]. Furthermore, a wide variety of tissue collection methods and DNA and protein preparation for molecular analysis has been at the root of many problems of irreproducibility. Standards development and best practices have been represented as cornerstones in facilitating biomarker validation [34,35]. Similarly, reacting to the lack of reproducibility of findings in some studies, proposals have been made for standards in study design for biomarker validation for risk classification and prediction [36].

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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