Why People Break Protocol

1241 Words 5 Pages
Despite the clear facts that the oncologist would be breaking protocol, benefits for both parties could arise from giving this drug to his patient. First, if indeed the drug has the effect on the girl that the researcher believes it will as she has the same genetic mutation in her tumor that responded in the rat model, then that could be a breakthrough for his project. Having high success early on could result in more funding and grants for the continuation of the trials as well as more publications. However, it is statistically unlikely that this will occur since the “average rate of successful translation from animal models to clinical cancer trials is less than 8%” (Mak, I., 2014). For the patient, it could mean getting closer to a cure …show more content…
Unfortunately, despite the warnings, people break protocol. Sometimes the researcher knowingly breaks the protocol, but it can happen accidently as well. In public cases, fraud or fabrication in trials can lead to widespread coverage and damage one’s reputation. In one example, Biotrial, a French company, made several mistakes during a Phase I drug trial that resulted in patient harm. They were testing a drug developed to treat a variety of diseases, but three major mistakes put the company in harm’s way. First, one of the volunteers was hospitalized after receiving his daily dose of the drug due to severe symptoms. Instead of pausing the study and waiting until they received a status update, the company proceeded to give the remaining test subjects their doses: they later found out the man in the hospital was brain dead. That finally caused the study to be stopped, but four other volunteers needed hospitalization. Besides the mistake of continuing a study despite having a patient in harm, Biotrial also failed to inform the other volunteers of the adverse effect the drug had on the aforementioned subject-violating the consent form, and the company did not report the incident to the French National Agency for Medicines and Health Products Safety until three days following the termination of the study (Enserink, …show more content…
Had the company stopped the study after the first man’s incident and reported the incident in a timely manner, the government could have prevented further damage to other trial subjects. Especially since death and severe illness occurred, this trial received negative media attention that tarnished the reputation of Biotrial. This example goes to show that even a slight deviation from procedures can result in unnecessary pain for many

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