One of the aims of the HARMONY Alliance 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 a consistent set of outcomes, a Core Outcome Set. Therefore, HARMONY researchers are currently running a series of special research projects called ‘Delphi Surveys’.
The first round of the surveys for AML, MM, NHL, and MDS have been completed, and the CLL survey has just opened.
Novel blood cancer treatments are 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 & Minimal Residue Disease 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 Core Outcome Set (COS) may offer a solution to these problems.
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. 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.
First, the core outcome sets of the individual diseases will be determined. Patients, clinicians, EFPIA members and regulators are invited to participate. Later, a core outcome set applicable to multiple blood cancers will be defined. This may assist researchers in selecting outcomes for future trials, thereby promoting harmonization of blood cancer studies and improving clinical management of the diseases.
- To learn more about Delphi Surveys and the HARMONY Alliance please visit www.harmony-alliance.eu