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Achieving Effective Haematological Oncology Clinical Trials


Date: April 14, 2016 (60 minutes)

Featured Speakers:

Haematology Oncology

This free webinar examines the nuances of successfully conducting haematological oncology clinical trials.

Haematological malignancies such as leukaemia, multiple myeloma and lymphoma represent a subset of indications within oncology that are wholly different from solid tumours. The growing haematological oncology therapy market is fueling both large numbers of clinical studies and, more importantly, an enhanced and refined understanding of cancer pathologies. Conducting clinical trials in haematological malignancies requires an understanding of a rapidly evolving treatment paradigm that is increasingly nuanced, complex and patient-directed. Companies developing haematological oncology therapies must capitalise on the principles and infrastructures shared by solid tumour oncology trials while adapting endpoints, study designs and data management approaches as well as considering patients’ experiences to address the particular challenges related to investigating candidate treatments for blood-based cancers.

Join this webinar to gain an understanding of critical differences between solid tumour and haematological oncology and a discussion on the nuances of conducting successful haematological oncology clinical trials.

Learning Objectives

  • Understand critical trial design considerations; including tumour type, standard of care vs research interests, and overall data capture nuances
  • Learn how to create meaningful, measurable endpoints and how they differ from solid tumour studies
  • Recognize how to effectively monitor and manage data and queries within oncology studies
  • Gain insight into selecting ideal trial sites for rare haematological malignancies and the importance of working with an oncology-experienced team

Keywords: Oncology, Clinical Trials


    Chris Smyth, Novella Clinical

    Chris Smyth, PhD, MBA, Managing Director, European & Asian Operations, Novella Clinical

    Based in Novella’s European headquarters in Stevenage, England, Dr. Chris Smyth oversees clinical research and operations in Europe and Asia. He also supports oncology delivery operations globally.

    Dr. Smyth has more than 20 years’ research and development experience in the pharmaceutical industry. He has led clinical research organisations and biopharmaceutical companies in both Europe and the US, dealing exclusively in haematology and oncology drug development since 2003.

    Dr. Smyth earned his PhD in Reproductive Biology from the University of Edinburgh and an MBA from Henley Management College, United Kingdom.

    Richard Gams, Novella Clinical

    Richard Gams, MD, Chief Scientific Officer, Novella Clinical

    Dr. Richard Gams is a board-certified haematologist/oncologist with more than 40 years’ clinical research experience. As Novella’s chief scientific officer, he guides training, protocol design, medical monitoring and pharmcovigilance, and is focused primarily on haematologic malignancies including leukemias, lymphomas, myelodysplasia and multiple myeloma. Prior to joining Novella, he played an instrumental role at Adria Laboratories (now part of Pfizer) in moving three breast cancer drugs and a therapy for acute myelogenous leukemia to FDA approval and commercialization in the 1990s, and later founded Prologue Research International, a contract research organisation. Dr. Gams served as a Professor of Medicine in the Division of Haematology/Oncology at the University of Alabama at Birmingham and Chairman of the Lymphoma Committee of the Southeastern Cancer Study Group. Additionally, he was Professor of Medicine in Haematology/Oncology and Director, Developmental Therapeutics for the Comprehensive Cancer Center (CCC) at The Ohio State University.


    This webinar is intended for haematology oncology professionals who oversee haematological drug development and clinical research in Europe and North America. Attendees may include:

    • VPs/Directors of Clinical Operations / Outsourcing / Procurement / Project Management / Study Management
    • Haematology/Oncology Division Leaders
    • Data Managers
    • Medical Monitors
    • Medical Advisors


    Novella Clinical, a Quintiles company, is a global, full-service clinical research organisation (CRO) serving the unique needs of small to mid-sized oncology companies. Novella’s dedicated oncology division is comprised of more than 700 oncology clinical trial specialists across all functional areas. We have specific oncology teams and processes to support haematological studies that include board-certified haematologists/oncologists on staff and oncology experienced CRAs. We are proud that 30 percent of our oncology portfolio focuses specifically in haematological oncology and our experience includes AML, CML, multiple myeloma, myelodysplastic syndromes, NHL and many rare indications. Learn more at www.novellaclinical.com/oncology.

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