Overcoming barriers to the implementation of patient-reported outcomes in cancer clinical trials: the PROMOTION Registry
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COMMENTARY
Open Access
Overcoming barriers to the implementation of patient-reported outcomes in cancer clinical trials: the PROMOTION Registry Fabio Efficace1*, Jonathan Rees2, Peter Fayers3, Andrea Pusic4, Martin Taphoorn5,9, Elfriede Greimel6, Jaap Reijneveld7, Katie Whale2, Jane Blazeby8 and On behalf of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Group
Abstract Every cancer treatment, irrespective of its clinical effectiveness, has an impact on patients’ quality of life (QoL). Even recently developed targeted therapies might have side effects and significantly impact patients’ QoL. Thus, understanding the advantages and disadvantages of different treatments from the patient’s standpoint has become a must in clinical research and is highly valued by major stakeholders. Thousands of cancer patients are enrolled into randomized controlled trials (RCTs) each year and many complete patient-reported outcome (PRO) instruments to obtain patient-centered information as part of the assessment of the overall effectiveness of the new therapy. Some of these RCTs have generated high quality PRO evidence forming the basis for approval (or support to approval) of drugs by the US Food and Drug Administration. However, a consistent strategy to determine the quality of patient centered evidence presented in RCTs has until recently been lacking. One of the fundamental questions when including PROs in clinical research revolves around methodological robustness and consistency of outcome reporting. Cancer patients, physicians and healthcare system stakeholders need to rely on solid information to make the best possible choice regarding treatment. Therefore generating high-quality findings from PRO assessment in cancer trials is of paramount importance. In an effort to improve quality of PRO assessment and reporting in the near future, the Patient-Reported Outcome Measurements Over Time In ONcology (PROMOTION) Registry was developed. The scope of this Registry is to identify, track, analyse, and store information on all cancer RCTs that have included PROs, and assess the quality of their PRO assessments. Keywords: Cancer, Patient-reported outcomes, Clinical trials, Quality of life, Clinical decision-making
Background Cancer is now an increasingly common diagnosis worldwide as population longevity increases. Recent data from the International Agency for Cancer research (IARC) indicate approximately 14.1 million new cancer cases in 2012, a rise of more than 10% compared to 2008 (12.7 million cases), and further projections suggest an increase to 19.3 million new cancer cases per year by 2025 [1]. Therefore, understanding how cancer and its treatment impact on each aspect of a patient’s life is critical and remains a major challenge. * Correspondence: [email protected] 1 Data Center and Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA), Via Benevento, 6, 00161 Rome, Italy Full list of author information is available at the end of the article
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