Dr Fonkoua on Clinical Trial Enrollment Disparities in Liver Cancer

Lionel A. Kankeu Fonkoua, MD, medical oncologist, Department of Medical Oncology, Mayo Clinic, discusses prevalent liver cancer clinical trial enrollment disparities.

Clinical trials intend to develop new treatments without harming patients along the way, making for strict eligibility criteria to minimize the risk for patients who participate in these trials, Fonkoua begins. Unfortunately, these criteria can create bias by representing only the healthiest patients or those who come from certain racial or ethnic backgrounds, he emphasizes. One such example is that Black patients tend to be disproportionately excluded from trials based on standard exclusion criteria. For instance, Black patients tend to have lower creatinine clearance levels than White patients, and established trial enrollment criteria regarding creatinine clearance levels should be adjusted accordingly, Fonkoua explains.

Other factors, including low albumin levels and infectious diseases, are significantly more likely to be found in patients of racial and ethnic minorities. These patients are more likely to be malnourished and have comorbid infectious diseases, he expands. Those factors inequitably exclude patients from clinical trials, Fonkoua says.

In liver cancer clinical trial eligibility criteria, Child-Pugh score has traditionally been used assess liver function, he continues. However, most clinical trials exclude patients who have a Child-Pugh score of B or C, only including the healthiest patients with a Child-Pugh score of A, Fonkoua emphasizes. Most real-world patients with liver cancer do not have a Child-Pugh score of A, and are thus ineligible for many clinical trials, he says. Therefore, the data that these trials generate are not representative of the entire liver cancer population. Instead, oncologists must rely on real-world evidence in addition to objective, high-level clinical trial data, Fonkoua says. Overall, these are some of the eligibility criteria that can limit the participation of patients from underrepresented minority groups and the extrapolation of data from clinical trials to the real world, he concludes.