Evidentiary standards

Altar CA, Amakye D, Bounos D, et al. A prototypical process for creating evidentiary standards for biomarkers and diagnostics. Clin Pharmacol Ther 2008 83 368-71. 

ADVANCING THE QUALIFICATION PROCESS AND DEFINING EVIDENTIARY STANDARDS SOS... 

The articulation of evidentiary standards will allow biomarker submitters to appropriately plan their qualification strategies and have more direct conversations with the FDA and EMA with the understanding that the level of evidence for qualification of a biomarker is directly related to factors such as the breadth of the stated COU, the implications for risk to patients if the biomarker fails, and the predictability of the assay performance characteristics. At this point the obvious evidentiary gaps include ... 

The Federal Rules of Evidence (ERE) were adopted in 1975. Subsequently most states (at least 37) have adopted their own codified rules of evidence modeled closely on the FRE. For scientific evidence, the most relevant of the Rules are found in Article VII of the FRE in a section known as Opinions and Expert Testimony. Prior to 1993, some federal appellate courts had applied Rule 702 of the Federal Rules of Evidence to medical and scientific experts. (Rule 702 authorizes scientific testimony whenever it will assist the trier of fact to understand the evidence or to determine a fact in issue.) In 1993, in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 US 579, the Supreme Court of the United States issued an important interpretation of Rule 702. Seven of the nine justices ruled that judges must serve as evidentiary gatekeepers who determine whether proffered evidence is scientifically valid and relevant. The Court suggested several factors for judges to consider in determining whether to admit a particular theory or technique Is the theory or hypothesis testable Has it been tested Has the theory or technique been subjected to peer review and publication For a particular scientific technique or methodology, what is the known or potential rate of error What (if any) are the standards that control the technique s operation To what extent is the theory or technique generally accepted in the scientific community ... 

W. P. Keeton, D. B. Dobbs, R. E. Keeton, D.G. Owen, Prosser Keeton on Torts, West Publishing, Fifth Edition (Hornbook Series, pp. 185-193). If an individual is sued for ordinary negligence, the court will compare his/her behavior to what any reasonable person would have done under the circumstances. However, if a safety and health professional is sued for malpractice, the court will compare his/her behavior to what a reasonable member of the profession would have done. Professional standards are much higher and much better documented and often ANSI standards such as ZIO serve to satisfy the evidentiary burden and to determine the appropriate standard of care. 

A second ICPMS analysis illustrates how variability can be addressed and quantitated. This report summarizes attempts to differentiate standard white office paper from several countries by using elemental analysis and simple statistical techniques, such as the f-test between means (Section 2.2.3). The authors evaluated a number of important considerations, such as differences between monthly batches and different rolls of paper produced on the same day. The results are summarized in Figures 14.3-14.6. In all elements analyzed, there was no significant difference in elemental concentrations between handled and unhandled paper. When several elements were evaluated, differences were seen between batches on the same day, as illustrated by cluster analysis, but principally between the first batch and all others. Overlaps between batches 2, 3, and 4 are evident. Variations between monthly batches are illustrated by means of cluster analysis and t-test results. These data show that the expected variation between batches is greater tiian that between different rolls produced on the same day. Also, data indicate a change in processing in May compared with the other months. This report is an excellent example of the need for meticulous and complete analytical work. Such backgroimd data are indispensable to the evaluation of evidentiary value, be it of paper, fibers, or any other type of evidence, esp>ecially mass-produced items. 

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