Diversity in Clinical Trials: Being Left Out

Diversity in Clinical Trials: Being Left Out By Marina Shayevich Why do African Americans develop breast cancers with significantly higher basal gene expression? 1 Why do Hispanics develop type II diabetes at an earlier age than other groups? 2 Understanding the functional reasons for disease processes is necessary to develop targeted treatments. Yet because clinical research lacks sufficient diversity, reasons for and mechanisms of disease development are not fully understood. Some reasons for minority patient under-representation in clinical trials are known. For example, strict eligibility criteria, like chronic kidney disease,3 hypertension or diabetes exclusions, leave out many groups, [...]

Federal Agency Perspectives on Clinical Trial Eligibility: Spring 2018

Federal Agency Perspectives on Clinical Trial Eligibility: Spring 2018 “Most current [breast cancer] clinical trials only enroll what I call the metastatic cancer ‘Olympians:’ the healthiest of the dying, those who are on their first or second line of therapy, who have limited metastases, who don't have brain mets, who don't have other diseases like diabetes or high blood pressure,” Dr. Kelly Shanahan, an obstetrician-gynecologist, activist, consumer reviewer for the Department of Defense Cancer Research Program and patient with stage 4 breast cancer said in an interview via email.1 Dr. Shanahan’s description matches many of the concerns [...]