What Is the Difference Between a Clinical Trial and a Real-World Study?

Real-world studies represent an important step in the medical research process, Dr. Alexander Spira explained in an interview with CURE.

“This phase [of the study] looks at real-world outcomes,” Spira explained. “It asks ‘Do patients do as well as they did in the clinical study? Is there anything different? In clinical studies, patients are different. They're different because they must be able to get to their clinical study site. Enrollment criteria [are stricter], so the patients tend to be healthier.”

Spira is a medical oncologist for Virginia Cancer Specialists and chief scientific officer for NEXT Oncology. He sat down for an interview with CURE onsite at the IASLC 2025 World Conference on Lung Cancer in Barcelona, Spain. Spira was in attendance to discuss long-term real-world outcomes of Lumakras (sotorasib) as a second-line and later treatment of patients with KRAS G12C-mutated advanced non-small cell lung cancer.

Transcript

Can you explain how real-world outcome studies differ from clinical trials? Why are these studies important for understanding effectiveness and patient experience?

This is what typically happens: first, we give the drug. The first thing we always think about is, “Do the drugs work?” That is the top-line information, but it's also important for patients to tolerate the drug, and that's about quality of life, which has really come to be important.

This phase [of the study] looks at real-world outcomes. It asks ‘Do patients do as well as they did in the clinical study? Is there anything different? In clinical studies, patients are different. They're different because they must be able to get to their clinical study site. Enrollment criteria [are stricter], so the patients tend to be healthier

Real-world outcomes involve looking at commercially available databases, of which there are a few, and basically asking the question: “What is the real-world experience? Is it working about as much, and what are the side effects?” The data are not as clean, because when you're part of a true clinical study, we use certain criteria. When you're looking at real-world outcomes, it involves extracting data that is maybe a little bit messier, but it still gives us a good result. It's clearly something that we look at, and there is good data to say that these studies provide good evidence.

Reference

1. “What Patients With Lung Cancer Need to Know About KRAS G12C Mutations,” CURE; https://www.curetoday.com/view/what-patients-with-lung-cancer-need-to-know-about-kras-g12c-mutations

Transcript has been edited for clarity and conciseness.

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