Recently the Cleveland Clinic’s Abby Statler discussed eligibility criteria exclusions for MDS clinical trials. She reports that observed outcomes indicate that eligibility criteria for patients with MDS relevant to liver function, renal function, and comorbidities should be relaxed. This could be especially the case for those with minor renal function abnormalities who evidenced comparable clinical outcomes to those without exhibiting similar abnormalities.
What is Myelodysplastic Syndrome (MDS)
MDS is a group of cancers in which immature blood cells in the bone marrow do not mature and therefore fail to become healthy blood cells. Early on, there are few symptoms, but later on, symptoms include fatigue, shortness of breath, easy bleeding, or frequent infections. Some types may develop into acute myeloid leukemia. About 7 out of 100,000 people are affected by the disease; about 4 out of 100,000 acquire the condition annually.
Rigid Trial Exclusion Criteria Needs to Change for MDS
American Journal of Managed Care (AJMC) interviewed Ms. Statler and asked why patients with therapy-related MDS are most often excluded from clinical trials involving MDS. Statler noted that they did publish a study revealing that patients with therapy-related MDS are likely disproportionately excluded from clinical trials. This, of course, is because these patients exhibit prior cancer, and traditional clinical trial eligibility precludes patients with prior cancers. There are a number of implications, but importantly that not enough of these patients are included in important and relevant studies and that outcomes may not be applicable with this specific patient population.
Abby Statler, PhD, MPH, MA, research associate at Cleveland Clinic