IMI-SISAQOL aims to develop a set of standards for the design, analysis, interpretation, and presentation of PRO data for cancer clinical trials.
Measures of health-related quality of life (HRQoL) and other patient-reported outcomes (PRO) generate important data in cancer trials to assist in evaluating the risks and benefits of cancer therapies, and fostering patient-centred care. However, the various ways that these tools are used, analysed and interpreted make it difficult to compare PRO findings across trials. This lack of consensus hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. SISAQOL will work to close these knowledge gaps and create international recommendations on how to analyse PRO data in clinical trials. It is hoped that guidelines and tools emerging from the project will facilitate the analysis of PRO outcomes and result in more reliable findings, improved interpretability, and faster dissemination of data that stem from a higher quality use of statistical methods.
Public – private collaborative research
The SISAQOL consortium is comprised of leading researchers and statisticians, key individuals from various international oncologic and medical societies, advisory and regulatory bodies, academic societies, pharmaceutical industry, cancer institutes and crucially patient advocacy organizations (represented by the WECAN and led by Myeloma Patients Europe) – with 41 stakeholder groups involved in the project. As a member of WECAN, ALAN will be providing input in various parts et steps of the project.
This project and its generated recommendations will be of critical importance to organisations like the European Medicines Agency (EMA) and the Food and Drug Administration (FDA), as PRO data presented uniformly across trials and cancers will help support fair and informed decision making. Robust and meaningful PRO data may also lead to improved shared decision-making between patients and their treating physicians. This in turn may lead to improved patient satisfaction, an increased likelihood of adherence to treatment, higher likelihood of treatment success, and a reduction in health‐care cost.
This four year collaborative project will develop a set of standards for the design, analysis, interpretation, and presentation of PRO data for cancer clinical trials.
SISAQOL-IMI is a public-private collaborative research project under the Innovative Medicines Initiative (IMI).