Real-World Evidence Complements Randomized Clinical Trial Data in Colorectal Cancer

In the above video, 3 leading experts in colorectal cancer (CRC) discussed how real-world evidence could help address unmet needs for patient populations typically ineligible for or underrepresented in clinical trials, clarify differences in treatment decision-making in everyday practice vs academic settings, and inform sequencing strategies for approved agents.

Insights were gathered from:

• Tanios S. Bekaii-Saab, MD, the David F. and Margaret T. Grohne Professor of Novel Therapeutics for Cancer Research I at the Mayo Clinic College of Medicine and Science and the chairman of the Division of Hematology/Medical Oncology at the Mayo Clinic in Phoenix, Arizona.
• Benjamin L. Schlechter, MD, a medical oncologist and senior physician in the Gastrointestinal Oncology Cancer Center at Dana-Farber Cancer Institute; as well as an assistant professor of Medicine at Harvard Medical School in Boston, Massachusetts.
• Cathy Eng, MD, FACP, FASCO, the David H. Johnson Endowed Chair in Surgical and Medical Oncology; professor of Medicine, Hematology and Oncology; director of the Young Adults Cancers Program, and codirector of Gastrointestinal Oncology at Vanderbilt-Ingram Cancer Center in Nashville, Tennessee.

Watch the video or read the transcript below to learn more!

For a more in-depth look at the importance of real-world data in CRC, check out our feature article.

Read more from the 3 experts below:

Bekaii-Saab: I see [real-world evidence] more as a complement than a challenge. Randomized clinical trials are usually a little bit more rigid in their design because they have to follow regulatory standards. They need to be established in a way that would allow the agent to be approved if the study is positive.

[However, randomized clinical trials] don't always answer a lot of questions that are more practical. They sometimes lack some level of pragmatism, which is where the real-world evidence comes [into consideration]. Essentially, [real-world evidence can] clarify some elements that are more related to day-to-day practice and can answer some of the questions, such as the sequencing of all these agents and strategies.

Schlecter: The experience from large clinical trials should inform clinical practice. Obviously, as a clinical trialist and academic oncologist, I want to get as many people on trials as possible so we can quickly answer [important] questions. We need to figure out what the important, clinically relevant questions are and then answer them effectively and rapidly.

In the past, we've depended on the cooperative groups to perform trials. There's a lot of concern about that right now. [There are concerns about] data collection, [including] who we're collecting [data from] and whether we are allowed to make distinctions on race and ethnicity, which are real differences in how patients do [on treatment]. There are probably sociological [rather than] biological differences, but we need to study them.

We should, as an oncology community, focus on clinical trial designs that are practical and inform practice. We need to disseminate them so that everyone adopts [best] practices quickly.

Eng:Two drugs have already been approved in the setting of previously treated [KRAS G12C–mutated] metastatic CRC, but we now have trials more specific to the KRAS G12C–mutant patient population. As a provider, [real-world evidence supporting the initiation of these clinical trials] entices me to try to obtain these drugs and participate in these clinical trials.

We want to encourage patients as much as possible to participate in clinical trials. It's of key importance. That's how we move the needle forward. Unless we have those patients who participate in trials, it takes so much longer to make progress. [I advise my colleagues to] continue to see what's available to them. [Patients should] continue to ask great questions of their treating physician and think about being treated outside the box and not just receiving the standard of care.