An Engine of Medical Progress: Clinical Trials

Clinical trials provide groundbreaking opportunities to discover treatments, whether drugs, devices or innovative approaches, for once-insurmountable diseases. These meticulously designed research studies drive medical progress in pursuit of better tomorrows and are constantly being evaluated for human safety. Those who courageously participate in these studies are the cornerstones of medicine as they pave the way for life-saving treatments and improved healthcare outcomes. Without patients’ willingness to participate, critical new treatments would be impossible, and the advancements in medicine would be further delayed.

Clinical trials have a long rich history dating back centuries, and their design and execution have continuously evolved alongside medical advancements. According to the National Institute of Health’s (NIH) article “Evolution of Clinical Research: A History Before and Beyond James Lind,” the first recorded study dates to biblical times (500 B.C.) and focused on legumes and lemons from a dietary therapy perspective. It was a trial conducted by King Nebuchadnezzar, who analyzed the nourishment these items provided after the 10-day experiment, compared to the other population, which ate only meat and drank wine.

Another popular study mentioned in the NIH article is the 1747 scurvy study by James Lind, who is considered the “first physician to have conducted a controlled clinical trial in the modern era.” As a working surgeon employed on a traveling ship, he was concerned by the high mortality rates of scurvy among the onboard crew. His trial consisted of analyzing 12 sailors who physically exemplified the same symptoms: rotting gums, spots and lassitude, and knee weakness.

He segmented the sailors into groups of two. Each group was given different items to digest: quart of cider a day, two spoonfuls of vinegar throughout the day, and two oranges and one lemon a day. Lind reported that the latter had the most visible positive impact on the disease, followed by drinking cider, which the popular adage of preventing scurvy with vitamin C derived from. As a result of Lind’s trial, the British Navy eventually required lemon juice to be a part of sailors’ diets, which was later replaced by cheaper lime juice.

Lastly, the word “placebo,” a popular term used widely in research, debuted in the early 1800s. It was defined as “an epithet given to any medicine more to please than benefit the patient” in Hooper’s Medical Dictionary of 1811. The earliest use of a placebo in a trial was in 1863 by American physician Austin Flint, who treated 13 patients diagnosed with rheumatism.

The NIH article explores other firsts in clinical trials: the first double-blind controlled trial for the common cold (1943) and the first randomized curative trial for streptomycin (1946). Clinical trials were eventually leveraged in cancer research. The National Cancer Institute (NCI) conducted the first randomized clinical trial in 1955 for patients with acute leukemia.

How Clinical Trials Work

Clinical trials provide immense insights into diseases and how best to treat them. Since the earliest of times, the goal has always been to learn if a given treatment is safe and effective for human use. A common misconception of studies is that they are unsafe for participants.

While they do carry risk as with any standard treatment or therapy, there are mandatory guidelines in place that clinical investigators must follow. The NIH’s article “Clinical Research: Benefits, Risks, and Safety” shares that one of these requirements is having an approved protocol that comprehensively outlines every step that will occur. Additionally, other safety requirements are in place:

• The Institutional Review Board must approve all clinical trials that test new treatments for patients in the United States.

• All clinical trials require written informed consent, which discloses to volunteers all risks and potential benefits of the study before participation begins.

• Clinical trials that test new treatments have committees, like a Data and Safety Monitoring Board and Observational Study Monitoring Boards, that constantly monitor the safety of the study.

Clinical trials undergo rigorous analysis and review before being made available to the public, and as mentioned, they follow strict guidelines to continue. NCI outlines the four necessary phases that any study must endure in its article “How Do Clinical Trials Work:”

• Phase 1 and phase 2 test for how the drug should be administered safely, capturing potential side effects and tolerance in a small group of volunteer participants.

• Phase 3 and phase 4 compare the study’s treatment to current standard treatments and then evaluate the side effects, risks and benefits over a longer period of time.

The researchers collect information and data from patients who participate in phases 1 through 3 and report to agencies, like the U.S. Food and Drug Administration (FDA), which make decisions about treatment approvals based on the data.

A Deeper Dive into Clinical Trials: The Benefits of Clinical Trials at Community Practices

Adapted from the AON blog article.

Patient participation is key to ensuring the efficacy and accuracy of clinical trials. However, patients aren’t as willing to enroll in trials as they have been in the past. One study conducted in 2020 by the Center for Information and Study on Clinical Research Participation (CISCRP) found that 49% of respondents were willing to participate in trials, which was down from 85% in 2019. One reason could be patient education; that same study showed that 36% of those polled didn’t understand clinical research very well or at all. That number was 10% in 2019.

Community oncology practices' participation in trials can ease the burdens of clinical trial participation by providing patients with access close to home and without travel requirements. This also allows them to participate in trials alongside nurses and physicians they already know and trust.

Getting Trials into the Communities

About 90% of cancer patients are treated at community practices, yet most clinical trials are performed at academic institutions, where they can be accessed by only about 10% of patients. This not only limits the number of patients who can enroll but also puts the additional burden of travel on those who do participate, especially those who live in rural areas.

By administering trials at community oncology practices such as those within AON, patients can access cutting-edge and innovative therapies and medications in the comfort and familiarity of their local clinic.

This benefits scientists and oncologists, too, as they can get a clearer picture of the efficacy of a certain medication or therapy when many patients enroll in a trial.

Addressing Patient Concerns

Patients undergo a rigorous screening process before enrolling in a clinical trial to ensure their safety.

Once patients are cleared, scientists, oncologists and nurses outline the process, explaining why the design of a certain drug fits their case and how it may aid in their treatment. If a patient has any concerns — for example, understanding potential side effects of the investigational treatment — it is covered in that discussion.

Once those conversations occur and questions are fully addressed, patients are typically very willing and engaged in the trials — especially when they realize their participation can help millions of others who are also fighting cancer.

To read other AON blog articles, visit AONcology.com/blog.

A Streamlined Partnership: How AON Supports Clinical Trials

AON is proud to support clinical trials across the country. At least thirteen AON practices participate in clinical research, and four are designated strategic research sites for the Sarah Cannon Research Institute. The practices in the network also offer patients over 150 clinical trials, which are conveniently accessible locally so that they can receive the latest treatments close to home.

AON’s infrastructure streamlines the clinical trial process, enabling independent practices to contribute to advancing cancer therapies. AON not only supports the heavy lifting on the administrative side through centralized regulatory and data operations but also supplies expertise and technology to help practices host more complex and, ultimately, more successful trials.

One of AON’s most unique assets to its practices is the ability to match a patient’s health data with a specific clinical trial’s eligibility criteria. The organization uses technology to help identify patients who match a study’s criteria and would potentially benefit most from participating. For example, using EHRs and other systems enables the team to match patients with trials based on criteria such as molecular defects or a change in tumor type.

Additionally, AON can help practices conduct their own trials, regardless of size, and help build their research programs. Regarding community trials, working with AON provides access to over 35 years of expertise to assist in this area.

Clinical trials bridge the gap between theoretical promise and real-world application, offering hope for patients and vital data for improving healthcare and patient care. While navigating the complexities of a clinical trial can require careful consideration, the potential rewards for patients, their families and physicians are undeniable. As research evolves and advances, clinical trials will remain at the forefront of unlocking new breakthroughs, ensuring many a brighter and healthier future. 