I work in the Michigan Clinical Research Unit (MCRU), a human clinical trial unit at the University of Michigan Hospital. MCRU provides the resources and infrastructure needed to conduct clinical research protocols and is sponsored by the Michigan Institute for Clinical & Health Research (MICHR). MICHR provides a wide variety of programs and services for University of Michigan investigators who are conducting clinical or translational research. Our research volunteers include both healthy persons as well as people with diseases refractory to standard treatments. Unlike the rest of the hospital, most of our patients are not acutely ill.
■ 8:00 AM
I look over today's schedule, which is particularly busy. A good portion of my time involves performing history and physicals (H&Ps) of study participants as part of the study screenings. I see that several participants will be receiving an infusion today. Although I am not directly involved with most infusions, I read the medical histories of the participants and familiarize myself with the type of infusion they will receive. One of the goals of these studies is to determine safety and tolerability of the agent; therefore, we need to be prepared to treat allergic reactions. Some of the participants will receive a placebo, but I won't know who they are because this is a double-blind study. I also read about the studies to remind myself of the goals, purposes, and interventions of the various protocols in order to tailor my exams appropriately. Mary, my nurse practitioner (NP) counterpart, and I divide the schedule up between us.
■ 9:00 AM
I attend an initiation meeting to discuss an upcoming study with the principle investigator (PI) and study coordinators. Some members of our research unit—including a nurse manager, a clinical nurse specialist, a lead lab technician, a bionutritionist, a pharmacist, an administrative assistant, an NP, and a PA—attend these meetings. We discuss the requirements for nursing assistance, lab draws, physical exams, diets, specimen processing, scheduling, and billing with the study team. This particular study protocol is on depression and associated emotional processing, and neurotransmitter functioning. The PI tells me that he wants me to focus on any medical reasons for depression that the participants may have when I examine them. For comparison, I will also be examining nondepressed control subjects.
■ 9:45 AM
A 32-year-old woman with metastatic sarcoma has arrived for her experimental treatment with Reolysin, a reovirus being tested in cancer patients. This is her second day of the 5-day treatment regimen. I briefly assess her for side effects. She tells me that overnight she had a headache and low-grade fever but is feeling better this morning. (Flulike symptoms are a common side effect of Reolysin.) I also check her lab results and call her oncologist to ensure that she is stable enough to receive another dose of the drug today. Many of us at the research center know this young woman, a mother of three, as she has been coming here for monthly treatments. We all pray that this regimen will finally prove effective for her.
■ 10:00 AM
My first H&P of the day is for an overweight 12-year-old girl. She is participating in a study on screening for prediabetes and diabetes in children and adolescents. The nurses have already inserted an IV and started an oral glucose tolerance test. Today she will also receive dietary counseling from one of our bionutritionists. I carefully examine her skin folds for acanthosis nigricans, the darkened skin pigmentation associated with obesity and insulin resistance. As I examine her, I am reminded of the growing problem of obesity in children in our country. I hope that taking part in this study will help this child and her parents better understand the health risks of being overweight and be motivated to eat healthier and exercise.
■ 10:45 AM
My next case requires a skin biopsy. This is a study on scleroderma and examines the inflammation and fibrosis of tissues caused by this disfiguring disease. The study participant is a middle-aged man with obvious hardened, thickened skin on his arms and face. The disease has affected his lungs as well. I look for a scleroderma-involved portion of his arm that is suitable for biopsy. After prepping an appropriate area of skin, I carefully inject lidocaine to numb the area. This is tricky because of the unyielding skin. I have to push the syringe harder than normal, and the lidocaine does not make its usual wheal that signals that the solution is in the skin. I proceed carefully with the punch biopsy to be sure that he is adequately anesthetized. His wife has agreed to be a control subject; therefore, my next task is to perform a skin biopsy on her.
■ 12:00 PM
I check in on one research subject who was admitted to our center for a 2-week stay. This is a normal, healthy graduate student who is taking part in a study of the relationship between growth hormone and weight regulation. Participants in this study are required to consume a high-calorie diet with limited activity for 2 weeks. This particular participant is feeling well physically but does appear quite bored after 5 days of this regimen. At the end of the study she will undergo a muscle biopsy. Because I am learning how to perform this procedure, I will perform it with the study physician.
■ 12:15 PM
I take a break to eat lunch, catch up on writing notes, and prepare for my afternoon appointments. My husband calls me to say hello and to ask if I petted the cat goodbye before leaving the house this morning.
■ 1:15 PM
I perform a follow-up exam on a participant in a study that will determine the effectiveness of a low-salt diet on chronic kidney disease. With the guidance of the research dieticians, this 66-year-old gentleman has been following a low-salt diet for the past month. During my exam, I focus on volume status markers, including lower extremity edema, lung crackles, and jugular venous distention. Since I last saw him, his leg swelling has markedly improved, his blood pressure has improved, and he is feeling better. Bioelectrical impedance testing (done by the study team) confirms the improvements.
■ 1:45 PM
My next participant has type 2 diabetes and is presenting for a screening visit for a study on peripheral neuropathy. I am careful to ask about the signs and symptoms of neuropathy and to assess neurologic functioning, including a monofilament foot exam. These study participants will also undergo further neuropathic testing in the hospital neurology lab.
■ 2:30 PM
My last H&P of the day is for an alternative medicine study involving the use of chamomile extract for chronic insomnia. I evaluate these study participants for secondary causes of insomnia, such as chronic pain and depression. Unfortunately, this study participant was a no-show. I joke with the staff that perhaps he was too tired to come today. In reality, however, there are many cancellations in the world of research. Our study participants are volunteers; many of them are generally healthy and often simply do not show up. Other participants present for their appointments but do not meet the inclusion criteria for the study. Some have decided not to participate after talking to the study team and reading the consent form. I take advantage of the extra time to do some medical reading.
■ 3:30 PM
I communicate via e-mail to study teams to clarify their needs for upcoming studies. I assist the nursing staff with blood draws, as a number of participants need labs at this particular time. I sign orders for a study participant arriving later this evening for an overnight admission. I also briefly review the next day's schedule. My first case for tomorrow is a fistula exam in a participant receiving an experimental treatment for Crohn's disease. In the afternoon, I will be traveling to an offsite clinic to examine subjects with fibromyalgia.
■ 4:30 PM
On the way home, I reflect on how different my current position is from my frenetic years in inpatient internal medicine. I saw much suffering inside the hospital walls during that time. It is intriguing to think that I am now involved in studies that aim to develop new understandings and treatments for various medical conditions. Although it may take many more study subjects before results are known and several years before others can benefit, anticipation of what the outcomes might promise is exciting. I feel privileged to play a small role in these endeavors. JAAPA
Alexandra Scott works in the Michigan Clinical Research Unit, University of Michigan Hospital, Ann Arbor. The author has indicated no relationships to disclose relating to the content of this article.