Why Scientific Validation Matters

Part 2

In our first installment of this series we introduced the importance of why scientific validation matters. In this chapter we will address some of the means used to demonstrate how compounds intended to affect human health, either naturally or pharmaceutically derived, are actually proven to work. There are several primary paradigms used by scientists — these include:

1. Basic Science Resarch
2. Animal Model Assays
3. Human Clinical Trials

Basic Science

Basic science experiments are designed to test fundamental hypotheses in the lab. This work can involve cell-based culture, in vitro analysis, gene and or protein expression assays and so on.

As a general rule, results of such experimentation are quantitated and then placed in context so that the investigator may ascertain the outcome of whatever variables he or she has examined. From such analyses, ground breaking discoveries may occur. It has been noted that the words most often ascribed to a ground-breaking basic science experiment are not "Eureka I've done it" but instead "isn't that strange...".

Animal Model Assays

In the past decade, the compassionate use of animal models has been refined, if not perfected. Though in a perfect world, it would be wonderful to not have to use animals in this way, we do not inhabit such a world. And when someone is ill, or they have an ill child, the utility of animal models to learn ways to cure disease becomes clearly understandable. Because human beings share 98% genetic homology with mice, a great deal can be learned from mouse-based experimentation.

Some exciting developments have recently occurred in that now, an ever-growing range of disease models have been created so scientific investigators can often learn things from such phenotypic animal models that they could never otherwise learn.

Human Clinical Trials

By far, the most relevant model under which human health science can be done involves actual clinical trials. Here, one highly useful approach involves dividing a population of disease affected individuals into groups so that one group can be treated with a putative medicine while another group can act as a control. In more sophisticated versions, both groups are blinded so that no patient knows whether they are being given the treatment agent or a placebo. In a still more refined version, the investigators are also "blinded" so that they do not know who is being given placebo and who is being given the putative treatment material.

During this process, data is gathered and transcribed. At some point, the clinical trial is concluded and the results are unblinded so that the investigators may observe response differences between the treated population and the control population. The unifying theme for each of these three primary paradigms is that an objective methodology is used in order to validate the data produced.

Another important unifying theme is that data results are submitted for critical peer-review. In our next chapter we will discuss the critical importance of the peer-review process.