Defining a core outcome set in multiple myeloma for future clinical trials

The HARMONY Alliance is a public-private European Network established in 2017, which currently includes 53 Partners and 43 associated members from 17 countries. One of HARMONY's goals is to use Big Data to improve understanding and treatment of hematological malignancies.

One of HARMONY's work packages is focused on defining core outcome set (COS) - outcomes that are relevant to each malignancy included in HARMONY.
This study will define the core outcome set in multiple myeloma (MM).

Different stakeholder will provide their expert feedback in a Delphi survey and rank different outcomes according to their importance. The different stakeholder groups include clinicians, patients and patient advocates and members of EFPIA (European Federation of Pharmaceutical Industries and Associations). A future use of COS can improve the comparability of clinical trials and the consistency of reporting. Therefore COS can help to ensure appropriate outcomes are measured in future clinical trials.

Contributors

Lars Bullinger, WP 2 Leader, HARMONY Partner Charit? Berlin
Renate Schulze-Rath, WP 2 Leader, HARMONY Partner Bayer
HARMONY Alliance, Healthcare Alliance for Resourceful Medicine Offensive against Neoplasms in Hematology
Katharina Lang

Further Study Information

Current Stage: Ongoing
Date: July 2020 - December 2020
Funding source(s): Innovative Medicine Initiative (IMI) 2 Joint grant agreement No. 116026


Health Area

Disease Category: Blood disorders, Cancer

Disease Name: Myeloma (also known as Multiple myeloma)

Target Population

Age Range: 18 - 100

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Regulatory agency representatives
- Researchers

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- Consensus meeting
- Delphi process

Delphi process, 3 rounds, and a final Consensus meeting

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