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Objective: To analyse how often innovations in healthcare are evaluated regarding output, especially in radiotherapy. Output was defined as either survival, toxicity, safety, service, efficiency or cost-effectiveness. Methods: A systematic literature review was conducted, using three search strategies: (1) innovations in general healthcare; (2) radiotherapy-specific innovations, i.e. organizational innovations and general implementation of innovations; (3) innovations per tumour group/ radiotherapy technique. Scientific levels were classified according to the system used in European Society for Medical Oncology guidelines. Finally, we calculated the percentage of implemented innovations in Dutch radiotherapy centres for which we found evidence regarding output in the literature review. Results: Only 94/1072 unique articles matched the inclusion criteria. Significant results on patient outcome, service or safety were reported in 65% of papers, which rose to 76% if confined to radiotherapy reviews. A significant technological improvement was identified in 26%, cost-effectiveness in 10% and costs/efficiency in 36% of the papers. The scientific level of organizational innovations was lower than that of clinical papers. Dutch radiotherapy treatment innovations were adequately evaluated on outcome data before implementation in clinical routine in a minimum of 64–92% of cases. Conclusion: Only few studies report on output when considering innovations in general, but radiotherapy reviews give a reasonably good insight into innovation output effects, with a higher level of evidence. In Dutch radiotherapy centres only small improvements are possible regarding evaluation of treatment innovations before implementation. Advances in knowledge: This study is the first of its kind measuring how innovations are evaluated in scientific literature, before implementation in clinical practice. [ABSTRACT FROM AUTHOR]

Import testing of medicines is performed in the middle of the legitimate supply chain when a product enters a country. Risks, however, are identified in the illegitimate supply chain and in the trade within a country. Hence, import testing does not add any significant value to the quality and safety of drugs nor reduces risks, provided the manufacturers apply good practices, for example, Good Manufacturing Practices (GMPs) and Good Distribution Practices (GDPs). The consideration to implement additional regulations does not correlate with the increasing convergence between National Regulatory Authorities (NRAs) and international harmonization, for example, Pharmaceutical Inspection Co-Operation Scheme (PIC/S) and International Council for Harmonisation (ICH). This publication reflects the historical application of import testing and today’s practice, concerns, and misconceptions of this redundant procedure. It explains why postmarketing surveillance testing is better suited to control the quality of medicines, addressing highly relevant concerns: counterfeits and supply interruptions. [ABSTRACT FROM AUTHOR]

Objective: To study the implementation of innovation activities in Dutch radiotherapy (RT) centres in a broad sense (product, technological, market and organizational innovations). Methods: A descriptive cross-sectional study was conducted in 15 Dutch RT centres. A list of innovations implemented from 2011 to 2013 was drawn up for each centre using semi-structured interviews. These innovations were classified into innovation categories according to previously defined innovation indicators. Where applicable, each innovation was rated by each centre on the effort required to implement it and on its expected effects, to get an impression of how far reaching and radical the innovations were and to be able to compare the number of innovations between centres. Results: The participating RT centres in the Netherlands implemented 12 innovations per year on average (range 5–25); this number was not significantly different for academic (n = 13) or non-academic centres (n = 10). Several centres were dealing with the same innovations at the same time. The average required effort and expected output did not differ significantly between product, technological and organizational innovation or between academic and non-academic centres. Conclusion: The number of innovations observed per centre varied across a large range, with a large overlap in terms of the type of innovations that were implemented. Registering innovations using the innovation indicators applied in our study would make it possible to improve collaboration between centres, e.g. with common training modules, to avoid duplication of work. [ABSTRACT FROM AUTHOR]

Objective: To study the efficiency of research implementation in a large radiotherapy institute, in either an internal review board-approved clinical trial or clinical routine. Methods: Scientific publications of the institute were listed. We asked clinicians from tumour expert groups whether the study had been implemented yet in a clinical trial or in clinical practice and which facilitators or barriers were relevant. An independent investigator verified all results. We calculated the implementation rates and the frequency of mentioned facilitators and barriers. Results: Resident researchers had published 234 studies over the past 4 years. Overall, 70/234 (30%) technical or preclinical studies were tested or implemented in a clinical environment in either trials or routine. In total, 45/234 (19%) studies were routinely implemented; in the 61 clinical studies, this percentage was higher: 38% (23/61). The main facilitator was the level of evidence and the main barriers were workload and high complexity. Conclusion: We were able to calculate the implementation ratio of published research into clinical practice and set benchmark figures for other radiotherapy clinics. Level of evidence was an important facilitator, while workload and high complexity of the new procedures were important barriers for implementation. Recent articles suggest that academic entrepreneurship will facilitate this process further. [ABSTRACT FROM AUTHOR]

Background.Trials are vital in informing routine clinical care; however, current designs have major deficiencies. An overview of the various challenges that face modern clinical research and the methods that can be exploited to solve these challenges, in the context of personalised cancer treatment in the 21st century is provided. Aim.The purpose of this manuscript, without intending to be comprehensive, is to spark thought whilst presenting and discussing two important and complementary alternatives to traditional evidence-based medicine, specifically rapid learning health care and cohort multiple randomised controlled trial design. Rapid learning health care is an approach that proposes to extract and apply knowledge from routine clinical care data rather than exclusively depending on clinical trial evidence, (please watch the animation:http://youtu.be/ZDJFOxpwqEA). The cohort multiple randomised controlled trial design is a pragmatic method which has been proposed to help overcome the weaknesses of conventional randomised trials, taking advantage of the standardised follow-up approaches more and more used in routine patient care. This approach is particularly useful when the new intervention is a priori attractive for the patient (i.e. proton therapy, patient decision aids or expensive medications), when the outcomes are easily collected, and when there is no need of a placebo arm. Discussion.Truly personalised cancer treatment is the goal in modern radiotherapy. However, personalised cancer treatment is also an immense challenge. The vast variety of both cancer patients and treatment options makes it extremely difficult to determine which decisions are optimal for the individual patient. Nevertheless, rapid learning health care and cohort multiple randomised controlled trial design are two approaches (among others) that can help meet this challenge. [ABSTRACT FROM PUBLISHER]

The improvement of radiotherapy depends largely on the implementation of innovations, of which effectivity varies widely. The aim of this study is to develop a prediction model for successful innovation implementation in radiotherapy to improve effective management of innovation projects. A literature review was performed to identify success factors for innovation implementation. Subsequently, in two large academic radiotherapy centres in the Netherlands, an inventory was made of all innovation projects executed between 2011 and 2017. Semi-structured interviews were performed to record the presence/absence of the success factors found in the review for each project. Successful implementation was defined as timely implementation, yes/no. Cross-tables, Χ2 tests, t-tests and Benjamin-Hochberg correction were used for analysing the data. A multivariate logistic regression technique was used to build a prediction model. From the 163 identified innovation projects, only 54% were successfully implemented. We found 31 success factors in literature of which 14 were significantly related to successful implementation in the innovation projects in our study. The prediction model contained the following determinants: (1) sufficient and competent employees, (2) complexity, (3) understanding/awareness of the project goals and process by employees, (4) feasibility and desirability. The area Under the curve (AUC) of the prediction model was 0.86 (0.8–0.92, 95% CI). A prediction model was developed for successful implementation of innovation in radiotherapy. This prediction model is the first of its kind and, after external validation, could be widely applicable to predict the timely implementation of radiotherapy innovations. [ABSTRACT FROM AUTHOR]