Articulating the “Value” of Healthy Volunteers to Drug Development

• In Event: Randomized Controlled Trials: The “Gold Standard” Between Theory and Practice

Abstract

Within drug development, it is common practice for pharmaceutical companies to design Phase I trials to use healthy volunteers as their research participants. In lay terms, these safety studies measure the negative side effects, or “adverse events,” that occur when research participants are given an investigational drug. Starting with small doses and increasing the number of milligrams over the course of a trial, investigators assess the “tolerability” of the drug as they seek to find a dose without burdensome side effects to use in future clinical trials. Given the risks of participation, how do researchers and ethics review boards explain the value of using healthy individuals in early-phase clinical trials? Drawing upon 22 semi-structured interviews with key informants who conduct or provide ethical oversight of Phase I trials, we analyze how economic rationales, such as cost and speed, factor into these trials’ design as much as do scientific factors. We also highlight the validity problems that these informants describe as endemic to healthy volunteer trials. These articulations of healthy volunteers’ value to the research enterprise baldly reveal the political and economic context of drug development. More importantly, our findings highlight the structural incentives that pharmaceutical companies have to use healthy volunteers to get their drugs to market as quickly as possible and to make their products appear safer than they really are. This paper contributes to STS work in the politics of knowledge, particularly research streams that examine how large industries use science to support their corporate interests.

Author

• Jill Fisher, UNC - Chapel Hill