‘Mind the gap’ between the development of therapeutic innovations and the clinical practice in oncology: A proposal of the European Organisation for Research and Treatment of Cancer (EORTC) to optimise cancer clinical research

Cancer survivorship: an integral part of Europe's research agenda

“…Clinical trials which record detailed and accurate information on treatment provide the best data source to estimate the risks of treatment-related side effects, for instance dose-response of late adverse effects (Maraldo et al, 2015). In the era of personalised medicine, long-term outcome databases are increasingly in demand to understand the long-term safety profile of newly approved drugs (Kempf et al, 2017).…”

Views of European Drug Development Stakeholders on Treatment Optimization and Its Potential for Use in Decision-Making

“…For instance, in a recent retrospective cohort study (Davis et al, 2017), it was concluded that 39 out of the 68 anticancer drugs approved by EMA between 2009 and 2013 entered the market based solely on improvements in surrogate outcomes and without having been shown to increase the overall survival or quality of life of patients, which are outcome measures that can be considered to be truly patient-centered (Kempf et al, 2017). At a minimum of 3.3 years after their registration, there were either still no data available indicating that they prolonged or improved patients' lives, or the observed gains were more often than not determined to be clinically insignificant.…”

“…Although the drug-driven approach to bring new treatments to the market should ideally be balanced with a more patientfocused strategy, the former tends to dominate treatment development in oncology. As a result, many important aspects relating to the use of novel antitumor therapies in real-world settings are neglected throughout the process (Kempf et al, 2017;Lacombe et al, 2017;Lacombe et al, 2019b), as displayed in Table 1. For now, such clinically important and patient-centered questions are being addressed in a non-systematic and voluntary manner in the post-approval stage by non-commercial entities (Kempf et al, 2017), including academic research teams and notfor-profit organizations such as the European Organisation for Research and Treatment of Cancer (EORTC), which conducts independent international clinical trials in the field of oncology.…”

“…As a result, many important aspects relating to the use of novel antitumor therapies in real-world settings are neglected throughout the process (Kempf et al, 2017;Lacombe et al, 2017;Lacombe et al, 2019b), as displayed in Table 1. For now, such clinically important and patient-centered questions are being addressed in a non-systematic and voluntary manner in the post-approval stage by non-commercial entities (Kempf et al, 2017), including academic research teams and notfor-profit organizations such as the European Organisation for Research and Treatment of Cancer (EORTC), which conducts independent international clinical trials in the field of oncology. However, given the uncertain nature of the funding available for studies performed outside of commercial interests, a more systematic approach is needed (Kempf et al, 2017).…”

“…For now, such clinically important and patient-centered questions are being addressed in a non-systematic and voluntary manner in the post-approval stage by non-commercial entities (Kempf et al, 2017), including academic research teams and notfor-profit organizations such as the European Organisation for Research and Treatment of Cancer (EORTC), which conducts independent international clinical trials in the field of oncology. However, given the uncertain nature of the funding available for studies performed outside of commercial interests, a more systematic approach is needed (Kempf et al, 2017). The industry has no incentive to invest in this type of research as its results can negatively impact the profitability of their products (Lacombe et al, 2019a), for example when it establishes a shorter overall treatment duration or a lower optimal dose.…”