Willow’s company has been contracted to oversee data management for a clinical trial. The trial is being conducted on a newly developed drug and consists of applying the drug on the subject’s skin and monitoring the effects the drug has. This trial is in the first phase of testing, meaning the goal of the trial to determine if the drug is safe for human use.
The drug is applied topically and the rate at which the drug is absorbed into the subject’s skin is monitored. After data had been collected from all the subjects participating in the trial, Willow analyzed the data and found that there was a wide range in the rate at which the drug was absorbed. All subjects were given the same dosage amount, and it was expected that the drug would be absorbed at a slow, constant rate. Some subjects showed this trend, while others absorbed the drug at a high rate, meaning a high concentration of the drug quickly entered their system. This was cause for concern because absorbing the drug at a high rate could lead to serious health consequences for the potential users of the drug.
Willow reported her findings to her client, the company which had developed the drug. Her report outlined the wide range in rate at which the drug was absorbed. The client was unsatisfied with the report and asked Willow to re-analyze the data. However, this time they requested a report which contained only the average rate at which the drug is absorbed. Willow knows that a report which only presents the average rate of absorption will not show all the safety concerns shown in the clinical trial data. However, her client ensures her that her report will only be used to show investors that the drug has progressed to clinical trials. Additionally, the company assures her that they are fully aware of the safety concerns associated with the drug and are currently researching methods to fix these problems.
What should Willow do?
Clare Bartlett was a 2014-2015 Hackworth Fellow in Engineering Ethics at the Markkula Center for Applied Ethics at Santa Clara University.
August 2015