The PROMOTION database is a registry of all cancer Randomized Controlled Trials (RCTs) with a Patient-Reported Outcome (PRO) endpoint published since 2004. The PROMOTION database now contains more than 900 PRO-RCTs conducted across a wide range of cancer specialties that have enrolled, overall, more than a quarter of a million of patients (see database content).
This is a large international initiative involving several key experts in quality of life and PRO research in oncology and is lead by Dr. Fabio Efficace, Head of the Health Outcomes Research Unit of the GIMEMA Foundation. This project started on April 2012 and it was initially also supported by a research grant from the EORTC Quality of Life Group to the GIMEMA. The Project also relies on the guidance of eminent experts, acting as Advisory Board members, and on an international network of dedicated Co-Investigators involved at different levels in the project, for example, identification of eligible studies for inclusion in the PROMOTION Registry, study evaluation, data collection and analyses.
The PROMOTION database contains several information regarding, for example, the PRO assessment methodology, the statistical design and the reported clinical and PRO results of RCTs. Such information is systematically collected and electronically archived into a password protected database. Typical data contained in the Registry are related, for example to: type of PRO instruments used, information regarding clinical significance of quality of life outcomes or details regarding the statistical approaches used to address missing quality of life data. A standardized working methodology is used and evaluation of studies that populate the database is performed using a common set of criteria across all cancer disease sites, thus allowing comparisons across all cancer areas.
Quality of life and other types of PROs are now frequently included as endpoints in cancer clinical trials. However, assessing PROs requires making a number of challenging decisions with regard to, for example, data collection, appropriate timing of assessment, adequate statistical analysis as well as outcome interpretation. Inadequate or poorly designed and reported PROs investigations in the context of RCTs, can mislead clinical decision making as it hampers a clear appraisal of the validity of the outcomes. Cancer patients, physicians and health policy makers should rely on the most solid evidence to make informed decisions. Therefore, providing the scientific community with high quality data in this area is of paramount importance. The PROMOTION Registry was thus developed to be a source of information to possibly answer a number of research questions revolving around the use and the added value of PROs assessment in cancer clinical trials. Several collaborations are now ongoing with a number of Universities and research groups dedicated to quality of life and PRO research in oncology and we welcome proposals for collaborations in this area.
Head, Department of Psychosocial Research, Division of Psychosocial Research & Epidemiology, The Netherlands Cancer Institute & Professor, Department of Clinical Psychology, The University of Amsterdam, Amsterdam, The Netherlands.
Professor of Surgery, University of Bristol, Bristol, United Kingdom (UK).
Emeritus Professor of Medical Statistics, University of Aberdeen, UK; Professor, European Palliative Care Research Centre (PRC), Norwegian University of Science and Technology, Trondheim, Norway.
Professor of Surgery, Department of Surgery, Harvard University, Boston, Massachusetts, USA.
Professor, Department of Medical Psychology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Senior statistician, Health Outcomes Research Unit, GIMEMA
Statistical Advisor for the PROMOTION Registry
Francesco Cottone supports the PROMOTION team in the statistical analyses and preparation of statistical reports of data contained in the PROMOTION Registry database.
He also assists PROMOTION team members in making decisions about the most appropriate statistical methods to use to address a specific research question.
Data manager, Health Outcomes Research Unit, GIMEMA
Project manager for the PROMOTION Registry
Francesco Sparano supports the Principal Investigator in all aspects of the project to ensure compliance with standard operating procedures and to ensure accuracy, completeness and proper usage of the PROMOTION Database. He is also responsible for checking data quality, coordinating the overall activities and communication amongst all collaborators from participating Institutions.