Are You Overvaluing Your Clinical Trial P-Values

By Ross Meisner and Bill Woywod. Published in Clinical Leader

Could you be risking your business by relying on clinical study p-values to make critical decisions on research and development, market development, and commercialization strategies?

A growing body of statistical evidence shows putting too much reliance on p-values can — and often does — lead to false conclusions and misconceptions. Statisticians around the world are coming together, warning entire industries against rampant human misinterpretation and an overreliance on the concept of the acceptance threshold, as noted in a 2016 statement from the American Statistical Association. In fact, a petition recently signed by 800 statisticians calls for the elimination of this “statistical significance” concept.

In practice, p-values are used to weigh evidence against the risks of a hypothetical concept. So, why does the life sciences industry persist in gauging critical business decisions on the value of probabilities alone, especially as myriad examples of missed opportunities and wasted resources continue to accumulate?

P-Values Matter

Like the rest of the industrial and scientific world, medical technology and pharmaceutical companies commonly use a p-value threshold of 0.05, which means research results with a p-value of less than 0.05 are considered a positive indicator of the hypothesis set forth, and anything greater as negative. It is critical to keep in mind this threshold, while agreed-upon, is arbitrary.

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