Ethical dimensions of research studies

Ethical Issues in Medicine

Ethical Dimensions of Research Studies

Ethical issues in medicine: Clinical trials and cancer patients.

Clinical trials, in which a treatment or a drug is tested upon human beings, are a vital part of bringing a drug to market. It is essential that the treatment be shown to be safe, effective, and better than existing treatments of similar cost and safety levels. However, when developing a drug for patients who are facing a potentially terminal diagnosis such as cancer patients, the ethics of using clinical trials becomes extremely murky. "To advance the science of medicine and improve the care of patients, we need the objective data that can only be gained from clinical trials, in which outcomes are dispassionately analyzed. But the patients in cancer trials are not data points; they are vulnerable people who often view a clinical trial as perhaps their last hope" (Markman 2003: 1008). They are human beings -- the mothers, daughters, fathers, and sons of loved ones -- who are in desperate need of hope and care. But a scientist cannot necessarily view them as such when constructing a research study.

For example, during Phase I clinical research studies, which are merely used to test a drug's safety, not its efficacy, many patients do not fully understand this when they agree to participate in a research trial. "Herein lies the ethical dilemma. Although, in theory, these patients may experience some clinically relevant benefit from the treatment such as improvement in symptoms or prolongation of survival, the realistic chances of this are slim in most (though certainly not all) phase 1 trials" (Markman 2003: 1008). In fact, for many patients who have undergone many treatments, participating in a Phase 1 trial may actually reduce the quality of their life, because of the side effects of the unproven medication on their delicate constitutions. Given the patients' desperation to find some way to prolong their lives, it is difficult for them to give full consent in a truly reasoned fashion. The scientists in charge of the study have an obvious vested interest in encouraging participation. "If the study is successful, the physician may publish an important paper, gain academic advancement, and even make a little money on the side if he or she owns stock in the company that makes the drug in question" (Markman 2003: 1008). However, physicians alone cannot be blamed. Internet chat rooms and the media can also fan the flames of hope.

In contrast, "Phase 2 trials are designed to evaluate efficacy so they might be expected to provide participants some measure of benefit," but even this can be a questionable prospect as different drugs may be in varied stages of to-market readiness, even if technically in a Phase 2 trial (Markman 2003: 1008). In fact, a patient may be lulled into a sense of overconfidence, because he or she is technically in a Phase 2 trial, but not be fully aware of the likely efficacy of the drug. Also, during any phases, patients must forego existing treatments which may have some efficacy to test the new treatment, which actually may be less effective. "Patients in a phase 2 trial of such a novel agent given as first-line chemotherapy will be participating more to generate information to help others than to help themselves…if the tumor progresses and produces symptoms during initial chemotherapy with the experimental drug, the patient actually may have been harmed by not receiving standard therapy first, even if ultimate survival is not influenced" (Markman 2003: 1013).