Subcommittee on Clinical Trials

Committee Roster

Chair
Grzegorz  S. Nowakowski, MD  ('24)

Vice Chair
Stephanie Valer Seremetis, MD  ('24)

Appointed Members
Uma Borate, MD  ('26)
Donna DiMichele, MD  ('26)
Martin  H. Dreyling, MD  ('25)
Nahed El Kassar, MD, PhD  ('25)
Jonathan Friedberg, MD  ('25)
Irene  M. Ghobrial, MD  ('25)
Neil Goldenberg, MD, PhD  ('26)
Nicole  J. Gormley, MD  ('25)
Alex  Francisco Herrera, MD  ('26)
Fangxin Hong, PhD  ('25)
Richard  F. Little, MD, MPH  ('26)
Alan  E. Mast, MD, PhD  ('25)
Lilli Petruzzelli, MD, PhD  ('25)
Elna Saah, MD  ('25)
George  A. Tomlinson, PhD  ('25)
Jeffrey  I. Weitz, MD, FRCPC  ('26)

Staff Liaison
Alice Kuaban, MS

Committee Mandate

As the need for more personalized therapies for hematologic diseases increases, effective collaboration between academic investigators, biopharmaceutical companies, and federal agencies is critical to (1) address existing challenges in the clinical trial design process and (2) identify new strategies that will enhance and accelerate drug development.

The Subcommittee on Clinical Trials, a subcommittee of the Committee on Scientific Affairs, identifies prominent barriers to the design of clinical trials for hematologic diseases, determines ways ASH could play a role in overcoming such barriers, and if appropriate, makes recommendations to the Society. Specifically, the subcommittee has the following goals and priorities:

·         Increase innovation and impact in hematology clinical trial design

·         Enhance access and enrollment into hematology clinical trials (especially for underrepresented populations)

·         Make hematology clinical trials easier to execute

·         Increase education for hematologists, patients, and other healthcare providers to raise awareness about innovative clinical trial approaches in hematology

·         Create pathways for lifelong learning in clinical trial methods and design

·         Improve methodological aspects of innovative clinical trial design

·         Disseminate innovative approaches in clinical research from other fields

·         Develop strategies to improve access and enrollment to hematology clinical trials for underrepresented populations (e.g., patient engagement, regulatory burden, cultural barriers)

·         Interface more with the US Food and Drug Administration, as well as other domestic and international regulatory agencies to discuss and help disseminate regulatory guidelines related to hematology clinical trials, real world evidence, and COVID-19

Members of the Subcommittee on Clinical Trials are appointed to three-year staggered terms (with the possibility of renewal once) and include experts from various stakeholder groups (i.e., academia, industry, regulatory agencies). The chair and vice chair each serve two-year terms. If not already a member of the Committee on Scientific Affairs, the chair of the Subcommittee on Clinical Trials serves as a liaison to the Committee on Scientific Affairs. The subcommittee’s leadership always represents both malignant and classical hematology.

Members of the Subcommittee on Clinical Trials are required to participate in regularly scheduled conference calls and one in-person meeting if deemed necessary.

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