EU Seeks Hematology Guidance
Europe aims to create new regulations regarding hematological malignancies.
The EMEA is proposing to create new guidance on hematological malignancies. The agency's idea arises from the recent increased activity in developing new treatments for hematological malignancies, including rare disorders and small target populations. This has led to a rise in applications for marketing authorization, but above all to numerous requests for scientific advice from the agency, prior to submitting an application.
The new guidance will deal with special considerations such as allogeneic stem cell transplantation and its consequences in relation to designation of primary endpoints. It will also take account of the use of molecular techniques in response evaluations, treatments administered with curative or palliative intent, and progression or relapse off-therapy. It will focus on the design of confirmatory studies, and will provide separate discussion of major diagnoses such as the acute leukemias, myelodysplastic syndromes, low and high grade lymphomas, and malignant myeloma. Other, rarer conditions will be covered conceptually. Most of the work will be carried out during this year—and anyone wanting to give their views to the agency is invited to do so until the end of this month.—Peter O'Donnell
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May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
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March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
