When I first heard the phrase “clinical research,” I immediately equated it with a clinical trial that determines whether a new medicine works. But I soon realized that clinical research is so much more than the final trial — it is an entire continuum, and the trial that results in new drug approval is only a small part of the spectrum.
The Final Product of a Clinical Research Success Story
I started thinking about the whole process of clinical research more clearly when my daughter got the flu last year. Since it had been going around, I knew what her symptoms meant and took her to the pediatrician right away. The doctor also suspected the flu, so we headed to the lab for a quick nasal swab and a short wait. After just a few minutes, the lab confirmed that she had tested positive for the flu, and we left with a prescription for Tamiflu. My daughter was feeling better within a day or so, and I made a mental note to be a better mom this year and get her a flu vaccination. It turns out that the flu is a great model to learn about the clinical research continuum.
Traveling Along the Clinical Research Continuum: The History of the Flu
An easy way to understand a process is to see it in action, and learning the history of the identification, treatment, and prevention of the flu provides an excellent example of the clinical research process at work.
- Identify the symptoms and what’s causing them. Though flu-like symptoms had been described for centuries, the flu pandemic in 1918 brought the disease to the forefront, and researchers noticed that multiple patients who were in close contact with each other developed the same illness. Epidemiologists learned about the transmission of the flu by studying the level of contact between patients, and determined that people developed the symptoms when someone near them coughed or sneezed. Because they understood how the disease spread, scientists assumed that the germ causing the flu — the pathogen — was found in the mucus from the patient’s nose or lungs. This led scientists to conduct experiments where the filtration of mucus from infected patients enabled them to identify the pathogen.
- Learn about the pathogen and how to target it to treat the disease. Scientists continued to learn more about this pathogen and identified it as a virus — the influenza virus — in the early 1930s. At this time, veterinarians had begun to vaccinate farm animals against other diseases by injecting them with small amounts of serum from infected animals. Additionally, the science of vaccination had begun to grow and evolve to produce more specific therapeutics that could also safely protect humans from infection. Before his seminal work in the development of the polio vaccine, Jonas Salk actually worked to produce the first influenza vaccine in 1943. By studying the structure of the influenza virus, researchers were able to discover the enzyme sialidase (also known as neuraminidase), which allows the flu virus to move through the upper respiratory tract and causes more of the virus to be released from infected cells (a very interesting, though a bit science-heavy, review here). This discovery led to the development of drugs like Tamiflu that inhibit sialidase and can shorten the duration of flu symptoms in affected patients.
- Develop diagnostic tests to quickly identify who will benefit from the new drugs. Knowing more about the virus also enabled the development of another important tool — a diagnostic test. That swab that doctors stick up your nose determines whether the influenza virus is present, and whether you are likely to benefit from the medication developed to fight it.
- Validate new drugs and diagnostics through clinical trials. The diagnostic that indicated my daughter had the flu and the drug, Tamiflu, that helped her recover, as well as the flu vaccine that I promised I would get for my daughter the following year — all of these were rigorously tested through multiple clinical trials to determine their safety and effectiveness.
The Clinical Research Continuum: Simply Stated
The flu provides a window into the full continuum of clinical research (and as the virus constantly mutates and changes, it continues to fascinate scientists). Epidemiologists notice that people are sick and observe them. Working together with scientists, they study those patients to figure out what is making them sick, and then the scientists head to the lab to study the cause of the illness. Learning more about the pathogen opens the door to the development of diagnostics, treatments, and even vaccines! Validation of the treatment’s safety and efficacy in a clinical trial is just the final step of the development process. In the case of the flu, the end result is an illness that is less frequent, because many are protected through vaccination, and less severe, because patients can be identified with diagnostics and treated with a drug.