The HARMONY Alliance Delphi Survey Hackathon for Chronic Myeloid Leukemia (CML), Hodgkin’s Lymphoma (HL), Myeloproliferative Neoplasms (MPN) and Waldenström Macroglobulinaemia (WM) took place on 4 and 18 March 2022. Patients, clinicians, regulators and drug developers were invited to participate. The Delphi Surveys for CML, HL, MPN and WM are now closed. Consensus meetings took place in May 2022.
Make use of our explanatory documentation:
- Flyer for patients and carers: We need your help to improve HL research >
- Factsheet: How does the HARMONY Delphi Survey work? >
- Factsheet: What is a core outcome set and why do we need your help? >
Challenge
At present, several innovative compounds are being tested in clinical trials in order to improve the treatment of HL. However, these trials measure different outcomes, thus questioning their comparability. In addition, the majority of clinical trials do not assess long-term side effects and their influence on the patients’ quality of life. A core outcome set (COS) may assist researchers in selecting outcomes for future trials, thereby promoting harmonization of HL studies and improving clinical management of the disease.
Aim
- To identify a minimum set of outcomes to be measured in future clinical trials in HL, agreed upon by all of HARMONY’s stakeholder groups.
- To enhance the comparability of clinical trials, in addition to improving the clinical management of ALL and guiding the collection of registry and real-world data through the use of a COS.
Approach
- This study will use the Delphi method to achieve a consensus on an iteration of a COS for HL adult patients. A representative panel of stakeholders will be asked to rate the importance of various outcomes in three iterative survey rounds. In the Delphi studies organized by the HARMONY Alliance, stakeholders are: patients, clinicians, researchers, regulators and members of EFPIA (the European Federation of Pharmaceutical industries and associations).
Impact
- Harmonizing future clinical trials in HL, thus facilitating the comparing and combining of data.
- Guiding the collection of real-world data.
- Improving clinical management by implementing the COS in clinical guidelines and practice.
- Improving patient-related aspects during and after treatment.
Project Summary
A COS is a minimum set of outcomes to be collected in future clinical trials which, ideally, have been agreed upon by all stakeholders. The COS is intended as an international standard to evaluate ALL treatments in clinical trials and other research settings (e.g., registry and observational studies). Using a COS will improve the comparability of clinical trials, enhance the consistency of reporting, and reduce selective reporting bias. The COS can also be incorporated into clinical guidelines and be used to improve patient management. This project aims to identify a COS for HL that will be accepted by all of HARMONY’s stakeholder groups.
The researchers will use the Delphi method to develop the COS. First, a preliminary list of about 60 outcomes was created, which is based on literature research and expert interviews. Next, a panel of stakeholders will be asked to rate the importance of each outcome on the basis of their personal experiences. Three iterative rounds are planned, using an online survey tool (COMET). After each round, the participants will receive an anonymized summary of the survey results per stakeholder group. This will allow them to revise their answers in the next round. It is expected that the group will converge towards a consensus COS after a number of iterations. The process will be stopped after pre-defined consensus criteria have been achieved. The final version of the COS will be aligned in a meeting with all participants.
Panel participants will be recruited from HARMONY Partners, including clinicians, patients, representatives from the pharmaceutical industry, and health authorities. The aim is to recruit equal participant numbers for all stakeholder groups wherever possible. This project is part of a series of Delphi studies for Hematological Malignancies that are being studied by the HARMONY Alliance. Ultimately, COS will be applicable to all Hematological Malignancies studied by the HARMONY Alliance.
Download the Delphi HL Study Protocol document to inspect the full outcome list >
Project Leadership
- Lars Bullinger, Charité, Germany – HARMONY Work Package 2 Lead
- Katharina Lang, Charité, Germany – HARMONY Work Package 2
- Renate Schulze-Rath, Bayer AG, Germany – HARMONY Work Package 2 Lead
- Martje Barbus, AbbVie, Germany – – HARMONY Work Package 2
Project Partnership
- HARMONY PLUS Partners from Work Package 2 & 4 & 5, active in health service, research, drug development and patient advocacy.
View all of HARMONY’s Research Projects and read more about the HARMONY Alliance and the HARMONY Big Data Platform.