One of HARMONY’s aims is to increase consistency in future clinical trials, allowing for the results to be compared and combined. To do this, clinical trials need to use consistent core outcomes. Therefore, HARMONY researchers are running several Delphi surveys to compile core outcome sets for hematologic malignancies. After a pilot study for Acute Myeloid Leukemia, the HARMONY Alliance has now launched a Delphi survey to develop a core outcome set (COS) for Non-Hodgkin Lymphoma (NHL).
Several new treatments for NHL are currently being tested in clinical trials across the world. Each trial uses its own outcomes to evaluate whether the treatment is effective. For instance, patients’ response to treatment may be described with complete remission, complete remission with incomplete hematologic recovery; complete remission and MRD negative; partial remission; or stable disease. This makes it difficult to compare and combine the study results. In addition, many studies do not assess long-term side effects of the drugs. As a result, it is difficult to draw firm conclusions about which treatments are optimal. A COS may offer a solution to these problems.
Lars Bullinger, Professor in Personalized Medicine at Charité and HARMONY Work Package 2 Leader: “A COS constitutes the minimum set of outcomes that should be collected and reported in future clinical trials in order to capture all relevant information, to better compare clinical trials and to advance novel treatment approaches faster. In the past, COS were often defined by individual stakeholder groups including patients, clinicians, health authorities and the pharmaceutical industry, but in HARMONY, we now for the first time will come up with COS defined by all stakeholder groups in a collaborative effort, thereby ensuring that the new COS for hematologic malignancies will be of high value to everybody.”
Renate Schulze-Rath, Director, Oncology1/WHC at Bayer and HARMONY Work Package 2 Leader: "I would like to emphazise that the strength of such a democratic approach is to listen to the voice of the different stakeholders like patients, clinicians, researchers, drug developers and health authorities and to come up with a common understanding of what is important for a better and effective treatment of NHL."
Natacha Bolaños, Global Alliances Manager at Lymphoma Coalition, and representative of the HARMONY Patient Cluster: "Patients must contribute to decisions about what outcomes are measured in trials and clinical practice. Lymphoma Coalition has enabled meaningful patient input to the core outcome set development, by identifying key elements of patient well-being. We have helped to define a long list of clinical and patient-reported outcomes, classifying them into outcome domains. The patient outcomes come from the findings of the Global Patient Survey that Lymphoma Coalition conducts every two years. Through this survey, the complexity of the patient perspective in lymphomas is captured, and the impact of treatments and care can be better measured and understood. Over 6600 respondents participated in the 2018 survey. We know Delphi surveys may intimidate patient participants. However, we want patients to feel confident that Lymphoma Coalition will continue to widen patient participation, promoting transparency and anonymity. We are pleased that patients will have a say in this Delphi Survey and the core outcomes set definition, to ensure the medicines of the future are being measured against not only treating the disease itself but also improving the patient’s quality of life."
Read about the full project scope of the NHL Delphi Survey Project: Towards a Core Outcome Set for Non-Hodgkin Lymphoma >
The NHL Delphi Survey is currently open. To participate, open this link: https://delphimanager.liv.ac.uk/HARMONY2/Delphi >
In close collaboration with the HARMONY Patient Cluster special informative documents are developed to invite and inform patients to participate in the NHL Delphi survey. Stay tuned for the various materials once finalized.
Become involved with HARMONY. Contact us to find out how you can participate in ongoing and future research initiatives.
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