Dr Abby Statler Speaks on Eligibility Criteria Exclusions for MDS Clinical Trials

Our outcomes suggest that eligibility criteria for patients with MDS relevant to liver function, renal function, and comorbidities may be relaxed, especially for those who have minor renal function abnormalities who have shown to have similar clinical outcomes to those without such abnormalities, said Abby Statler, PhD, MPH, MA, research associate at Cleveland Clinic.

Transcript

Your research has shown that patients with therapy-related myelodysplastic syndrome (MDS) were often excluded from trials for MDS. Why do these patients get excluded, and what is the impact of not having them in these trials?

Yeah, that's a great question. So, we published a study earlier this year that suggests patients with therapy-related myelodysplastic syndrome may be disproportionately excluded from clinical trials. This is primarily because a great proportion of these patients have a prior cancer and traditional eligibility criteria for clinical trials exclude patients with prior cancers. So, this means that in general, clinical trials that have been studying interventions in the MDS patient population may have been systematically excluding these patients with tMDS [therapy-related myeloid neoplasms] because of their prior history. So, as we think about the implications of this, we can consider the fact that clinical trials that have been run over the last several decades may not have been including an appropriate proportion of patients with tMDS because of these eligibility criteria.Therefore, the outcomes may not be applicable within that specific patient population. So, it's extraordinarily important as we move forward, and we design clinical trials, that the eligibility criteria are designed in a way that appropriately includes patients with tMDS.

What steps can be taken to help relax eligibility criteria and have more of these patients represented in MDS clinical trials?

So, our outcomes suggest that eligibility criteria relevant to liver function, renal function, and comorbidities may be relaxed. So specifically, our outcomes suggest that patients who have minor renal function abnormalities have similar clinical outcomes to those without such abnormalities. So, we can relax those criteria, specifically, removing exclusion criteria relevant to clearance abnormalities. For liver dysfunction. Our outcomes suggest that we might be able to remove exclusion criteria relevant to as AST, ALT, and minor bilirubin abnormalities—all of which measure your liver function. Then finally, for comorbidities, our outcomes indicate that patients who have comorbidities have similar outcomes to those without such comorbidities. So, removing eligibility criteria relevant to comorbid conditions may also be appropriate. Now, the one caveat that I do want to mention is that patients presented with chronic liver conditions did have worse clinical outcomes than those patients without such conditions. So, it may still be appropriate to exclude those patients from clinical trials.