One of HARMONY’s aims is to increase consistency in future clinical trials therefore allowing for the results achieved to be compared and combined creating increased value to the hematological community. To do this, clinical trials need to use consistent core outcomes, please help which outcomes should be chosen. HARMONY researchers are at this time compiling a set of the most important outcomes for AML by consulting a panel of stakeholders.
Access to the Delphi survey > https://delphimanager.liv.ac.uk/HARMONY/Delphi
The team of HARMONY Work Package 2 is coordinating an endeavor to define a COS for AML. AML is the most common Acute Leukemia in adults. Despite recent scientific advances, AML cure rates remain poor compared to other hematologic malignancies. In addition to accelerating clinical research, defining a COS may help to improve the clinical management of AML. In the pilot study, HARMONY will focus on outcomes for AML in patients 18 years and older.
The Pilot Study uses the Delphi method. This method will help to ensure that the COS represents the priorities of clinicians, industry, health authorities, and patients alike. After completion of this pilot, we will start similar projects for the other Hematologic Malignancies that are being studied by HARMONY. "we want to define a COS which will apply to all seven hematological malignancies. In the long term, we hope that patient satisfaction during and after treatment may be improved with the COS”, acoording to Lars Bullinger (Charité), who together with Renate Schulze-Rath (Bayer AG), is leading HARMONY Work Package 2, which in collaboration with HARMONY Work Package 6, focuses on Definition of Outcomes.
A COS constitutes the minimum set of outcomes that should be collected and reported in future clinical trials. A COS will be defined by several stakeholder groups including patients, clinicians, health authorities and the pharmaceutical industry. Of course, researchers may include additional outcomes in a particular trial. A COS functions as an international standard to evaluate treatments in clinical trials and other research settings (e.g., registry and observational studies) to assess real world data. Implementing a COS will improve the comparability of clinical trials and observational studies, improve the consistency of reporting, and reduce selective reporting bias. In addition, the COS can be incorporated in clinical guidelines and be used to improve patient management.
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