As research continues to explore alternatives to chemotherapy in treating MDS, drugs targeting gene changes inside cells are bringing hope to patients afflicted with this debilitating disease. Researchers are making progress in understanding how normal bone marrow cells can develop into myelodysplastic cells. New approaches to stem cell transplants offer the potential to enhance effectiveness and reduce side effects and other complications. And accelerated approval pathways can be an option to bring these treatments to patients awaiting them.
Navigating the operational and regulatory challenges, however, requires highly specialized skills. For example, genetic markers required for enrollment must be developed and validated, often requiring companion diagnostics. A rapidly changing treatment landscape complicates control-arm and endpoint selection. Overall survival requires longer follow-up periods. Accelerated approval pathways require stringent management of post-marketing commitments, and novel therapeutic modalities require specialized monitoring
As a global leader hematology, Parexel draws on unrivalled site knowledge in MDS. Our network comprises 78 alliance members and more than 400 experienced principal investigators worldwide.
Experience in the past 5 years in MDS
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