At it's core, a clinical trial is a medical experiment designed to increase society's knowledge of an illness, condition, or malaise. In the media, "clinical trials" are usually only referenced when discussing a new, promising drug making it to human efficacy trials. Numerous news reports discuss a new "miracle" drug being close to the market for diseases from cancer to heart disease. In reality, clinical trials exist in many other forms than simply testing new medications. Screening trials look for better ways to diagnose diseases; quality of life trials are designed to improve the living conditions of those afflicted with chronic diseases; and clinical observation studies involve physicians simply measuring outcomes without providing interventions. It is within this third form that we will find a relationship with the ethical concept of "standard of care."

The concept of standard of care is primarily relevant to malpractice/negligence lawsuits against physicians, but their definition extends to clinical trials and beyond. In brief, standard of care is the expectation that a patient will receive the same level of care that a prudent practitioner would provide in any given situation under the same circumstances. For example, chemotherapy is the standard of care treatment for most metastatic cancers; if a physician who had chemotherapy drugs available refused to administer chemotherapy to a patient with obvious symptoms of metastatic cancer, he or she would be found negligent on the basis of standard of care expectations. If the same physician did not administer medication because it was not available at his clinic or hospital, then he or she could not be deemed negligent.

Clinical trials are unique because they are necessary for the progression of medicine and medical care, but they go against some of the core tenets of medicine. Clinical trials, for the most part, are designed to forsake the health of the individual for the sake of future populations. When a patient is enrolled in a clinical trial for an experimental medication, it is generally a foregone conclusion that they don't have any other options. While the patient's family may believe the experimental drug will help their debilitated family member, the odds are heavily, heavily stacked against them. Medicine, at it's core, is about treating the individual patient who presents at the clinic. Clinical trials are entirely about treating those who become sick in the future, which is extremely removed from the core tenet of medicine.

Standard of care becomes relevant to medical research when trials are completed in resource poor areas or are focused on disadvantaged populations (places where the trial enrollees have low expectations of care). To follow the ethic of standard of care, the researcher needs to answer the question "Would the subject receive this care absent the clinical trial?" If the answer is "no", then the researcher is not ethically required to provide that treatment. While this makes logical sense, as it leaves the researcher as a more passive member of the community and removes variables that could influence the experiment, it creates ethically questionable situations beyond the "standard of care" dilemma presented earlier.

The infamous Tuskegee Syphilis Experiment is likely the most famous example of these situations in medical research, and was partially responsible for the establishment of internal review boards and national patients rights for those enrolled in clinical trials. In short, the Experiment was a rather harmless prospective study where they were monitoring the long term health effects of untreated syphilis before treating them with ineffective, contemporary techniques that became infamous because they never informed their patients that they were infected nor did they provide penicillin to their patients (which, at the inception of the study, had not yet been invented). When the study was initially approved and began data collection, penicillin was not being used to treat syphilis. Therefore, the investigators did not have an ethical requirement to provide the drug to their patients. However, once the program lost funding and penicillin was discovered, two events that happened relatively close in time, the ethical requirements for the researchers were muddled at best. They alone had the knowledge of the infection status of their enrollees, but, as the project was no longer active, the researchers did not feel it necessary to inform their patients nor provide treatment. When a whistleblower revealed the details of the study and the inaction from the researchers in 1972, there was an extremely strong public backlash that eventually ended with President Bill Clinton's public apology in 1997.

In 2000, a similar study reignited the debate regarding standard of care in clinical trials. The article "Viral Load and Heterosexual Transmission of Human Immunodeficiency Virus Type 1" by Quinn, T., et al., was published in the extremely reputable research journal The New England Journal of Medicine (The head author is, coincidentally, a professor at the Johns Hopkins Bloomberg School of Public Health). The observation trial was attempting to find a linear link between viral load of HIV type 1 and rates of transmission (In layman's terms, they wanted to see if the rates of infection for the partners of those infected increased as the number of viruses per mL of bodily fluid of those infected increased). Undoubtedly, this information is very useful for the medical community. Antiretroviral therapy (ART) is one of the most common treatments for HIV worldwide, and one of it's main benefits is reducing the viral load in the body. If there was a threshold for which one could engage in sexual activity without fear of transmitting the virus to their partner, the quality of life of those infected would increase significantly.

The controversy for this study arose from it's relationship to standard of care and the study design. For the data to be accurately collected, the patients obviously couldn't know their infection status of it may have affected their sexual activity. And, as these enrollees wouldn't normally have had access to healthcare, the researchers had no standard of care ethical obligation to provide this information to their enrollees. As you can probably see, the researchers were actively complacent as multiple people in the village they were working in were infected with HIV, a disease that is essentially a death sentence in these rural areas. The study wasn't designed as some rogue investigation; the study design was reviewed and approved by the AIDS Research Subcommittee of the Uganda National Council for Science and Technology, Columbia University, Johns Hopkins University, and the National Institutes of Health Office for Protection from Research Risk. From a standard of care viewpoint, the researchers did nothing wrong. But when one steps back, they realize that the researchers were basically sacrificing the study population for the benefit of others, an idea that goes against the goals of medicine.

Standard of care walks a very precarious line in medical research. Some would argue that, on one hand, it is necessary to complete these studies for the greater benefit of humanity and the only areas they can be ethically completed are in these poor areas such as rural Alabama or Africa. However, to argue that viewpoint one has to believe that the lives of these people are less important that who could be helped. Those who would feel the benefit of this research are not those in the areas that the studies are completed. New advances in ART scheduling are not going to improve the livelihoods of those in the rural village in Africa, although they are the ones who have to suffer for the advancement. The situation is different for people enrolled in experimental drug treatments; these people will likely succumb to their illness regardless of the trial. In Tuskegee and Quinn et al., the researchers had the ability to ease the suffering of their subjects. The hippocratic oath calls on physicians to "remember that I remain a member of society, with special obligations to all my fellow human beings, those sound of mind and body as well as the infirm." In these studies, the physician did not meet that call. Too often and too easily, we, as a society, sacrifice those at the bottom for the benefit of those at the top. The standard of care argument has its merits when used in an appropriate context, but when researchers can use it as a crutch to avoid providing treatment to the poor, it loses value and is simply another method of waging an unconcious war against the poor.

This piece was heavily influenced by Dr. Paul Farmer of the Department of Global and Social Medicine at Harvard Medical College. In particular, most of the ideas for this piece came from Chapter 8: "New Malaise" of his book Pathologies of Power: Health, Human Rights, and the New War on the Poor (University of California Press, 2005).