Legacy
Work Packages

2: Definition of Outcomes

WP2 is focused on defining the specific questions that are relevant to each hematological malignancy (HM). The coordination of the data that emerges will ensure that results will be generally applicable to patients with blood cancers. WP2 will define what outcomes need to be achieved in terms of each type of blood malignancy, including both clinical outcome measures and the description of which factors are relevant for both patients and caregivers. Read more about the HM focus and the HARMONY Research Projects >


Objectives

  • Reviewing all the literature that has been published about defining outcomes and how these outcomes have been measured and reported on in the past;
  • Identifying overarching questions/aims/goals in order to align core standard outcomes sets under the guidance of key opinion leaders (KOLs) and other stakeholders;
  • Aligning core standard outcome sets with the relevant payers, providers, regulatory and health technology assessment (HTAs) agencies in order to coordinate the work with maximum efficiency;
  • Contributing to the resolution of legal issues that might arise from data sharing and data storage and from European meta-analyses (in close collaboration with WP3, WP4, WP6, and WP8);
  • Facilitating collaboration with other groups, thus enabling all of the work to be aligned and coordinated;
  • Defining the most important problems that should be addressed by HARMONY and specifying out expected outcomes.

Work Package Partners

AEMPS, AIEOP, Amgen, Barts Health, Bayer, Celgene, BfArM, Erasmus MC, ERIC, FISM Onlus, GFM, Goethe University, GPOH, GRAALL, HHU, HULAFE, IECSCYL-IBSAL, IJC, Janssen, LeukaNET, LMU, LYSA, Menarini, MU, Newcastle University, NICE, Novartis, OPBG, SYNAPSE, Takeda, University of Ulm, UNAM, UNIBO, UNITO, University of Cambridge, University of Navarra, University of Rome Tor Vergata, VHIO, VUMC.


Work Package Leadership

“Hematological malignancies (HMs) are a role model for the treatment of many cancers. Being characterized by a tremendous heterogeneity, HMs are hard to come by with “one size fits all” treatment strategies and today many open questions remain concerning their management. To capture the complexity of the disease, individual working groups and all stakeholders involved in the treatment of HMs, are joining efforts. WP2 will define important questions, co-ordinate respective projects with a focus on the appropriate selection of outcome measures. These measures should become applicable as standard outcome sets with the ultimate goal to improve HM management and patient centered treatment approaches.”

Lars Bullinger, Professor in Personalized Medicine, Charité
WP2 Leader

“Looking forward to working together with so many public and private partners on defining outcomes sets for HMs which include both clinical outcome measures and patient factors for patients and caregivers.The shared goal is to establish a system to improve rapid decision-making in the interests of better therapy access and care for patients with HMs.”

Renate Schulze-Rath, Director, Oncology1/WHC, Bayer
WP2 Leader

“HARMONY is a unique initiative that is collecting and integrating a large amount of molecular data of patients with hematological malignancies (HMs) in order to characterize the molecular landscape of HMs, understand their pathophysiology, identify novel drug targets and pathways. WP2 is in close collaboration and alignment with the other work packages and different stakeholders, as the objectives of WP2 are tightly connected to the other work packages, including identification and acquisition of suitable data sets, alignment of a core outcome set and coordinating different scientific projects.”

Martje Barbus, Medical manager hematology, AbbVie
Co-leader

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Spain

  • PETHEMA – Programa Español de Tratamientos en Hematología
  • Jose Carreras Leukemia Research Institute
  • Spanish CETLAM Cooperative Group
  • Hospital 12 de Octubre – i+12 Instituto de Investigación
  • Hospital Universitario La Fe
  • Fundació Institut Mar D´Investigacions Mèdiques
  • Complejo Asistencial Universitario de Burgos
  • Ramon y Cajal University Hospital
  • Infanta Leonor Hospital
  • Costa del Sol Hospital
  • Hospital General Universitario Valencia
  • Catalan Registry of CML
  • Hospital Universitario de Gran Canaria Doctor Negrín
  • GESMD – Grupo Español de Síndromes Mielodisplásicos
  • FICUS – Fundación de Investigación del Cáncer de la Universidad de Salamanca / CIC Salamanca
  • Registro Gammapatías Castilla y León