In March this year, the U.S. Food and Drug Administration (FDA) released new, nonbinding recommendations for enrolling more elderly patients in clinical studies in oncology, including in the early phases. In her latest ESMO On target column, VHIO’s Elena Garralda, Director of our Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch, focuses on the longstanding problem of the underrepresentation of people over the age of 65 in clinical trial enrollment, especially adults over 75.
In her latest piece, Elena briefly highlights the ongoing and dedicated efforts aimed at boosting the participation of these patients by making clinical trial design more inclusive, including new guidance provided by regulatory agencies such as the FDA and the European Medicines Agency (EMA), the dedicated work of task forces established by professional societies such as the American Society of Clinical Oncology (ASCO) and ESMO, as well as other organizations including the European Organisation for Research and Treatment of Cancer (EORTC).
Returning to the recent release of FDA’s latest recommendations, she summarizes some of the guidance points and welcomes this development as an important next step toward necessary change.
To read this ESMO Perspectives On Target column and access Elena’s past editions please click here.