Radiation therapy: Regulatory framework and constraints.

The purpose of this article is to describe the regulatory framework of the radiotherapy practice in France.

Quality/risk management system in radiotherapy: Changes afoot.

The French sanitary and regulatory context in which radiotherapy centres are comprised is evolving. Risk and quality management systems are currently adapting to these evolutions. The French nuclear safety agency (ASN) decision of July 1st 2008 on quality assurance obligations in radiotherapy has reached 10 years of age, and the French high authority of health (HAS) certification system 20 years now. Mandatory tools needed for the improvement of quality and safety in healthcare are now well known. From now on, the focus of healthcare policies is oriented towards evaluation of efficiency of these new organisations designed following ASN and HAS nationwide guidelines.

[Application of the « Junior Doctor ¼ status in Radiation Oncology]. / Guide du Docteur Junior en oncologie-radiothérapie.

Introduced in 2017, the reform of the 3rd cycle has modified the organization of the residency in all specialties, and in particular radiation oncology. The residency was thus divided into 3 phases with increasing knowledge and responsibilities. The latter, carried out under the status of "junior doctor", created and defined by decree n°2018-571 of July 3, 2018 and the decree of January 16, 2020, is a phase of supervised autonomy of the resident. Radiotherapy is a singular specialty, with multiple and complex activities, and requires multiple skills. A guide defining the status of the "Junior Doctor" in radiation oncology therefore appears necessary, defining each resident's role and obligations. This guide is of an advisory nature and must be adapted to the particularities of each department. This guide aims to help the implementation of the reform of the 3rd cycle in radiation oncology and especially the final year called the consolidation phase. It is destined to evolve, expanded by individual and collective feedback and the constant renewal of our speciality.

[Research ethics: French regulations and applications in radiation oncology]. / Éthique de la recherche : réglementations françaises et applications en oncologie radiothérapie.

French regulations about research ethics are based on the so-called Jardé law, which defines researches involving human beings. Researches involving human beings require the submission of research protocols to a committee for protection of persons with a precise list of documents to submit for a favourable opinion. This law describes different categories of researches and determines the ethical procedures to apply before setting up a research protocol. This issue of categorisation is central and must be taken into account by researchers from the beginning of the research process. Researches considered as not involving human beings also require a set of ethical precautions focused on patients' information and the collection of their non-opposition (due to the application of the General Data Protection Regulation adopted by the European Parliament). Thus, many regulations exist and they require a real work for researchers to meet these requirements in research ethics. This article aims to summarise French regulations. Selected examples are specifically taken into the field of radiation oncology research.

Patient safety in radiation oncology in Spain: a need to change.

PURPOSE: The Working Group on Patient Safety and Quality of the Spanish Society of Radiation Oncology, revised the most relevant national and international recommendations, selecting a series of important aspects for patient safety, evaluating whether they are included in Spanish legislation MATERIALS AND METHODS: We have considered a concept as relevant to the patient safety in radiotherapy if so defined in at least 8 of the 16 documents reviewed. RESULTS: 12 subjects were selected: training and qualification, human resources, protocols, safety culture, communication, peer review, accreditation: audits, checklists, areas without interruptions, maps of processes and risks, prospective risk analysis, notification, registration and incident learning, and quality control of the equipment. CONCLUSIONS: At the legislative level, as well as the professional organizations and the health center directorates, the implementation of safety culture must continue to be fostered. Only in this environment will the tools and measures to increase patient safety be effective. The current Spanish legislation must be revised and updated, in accordance with directive 2013/59/EURATOM and the Patient Safety Strategy 2015-2020 of the Spanish National Health System, introducing the obligation to perform risk analysis and incidents management. Audits and accreditations must be carried out, thus raising the general level of practice of the specialty. In this process, the Spanish Society of Radiation Oncology must continue playing its fundamental role, collaborating with the institutions and the rest of the scientific societies involved in the radiotherapy process, issuing recommendations on patient safety and disseminating the safety culture in our specialty.

Use of radiobiology in medical jurisprudence, with particular reference to delays in diagnosis and therapeutic onset.

OBJECTIVE: This paper considers aspects of radiobiology and cell and tissue kinetics applicable to legal disputations concerned with diagnostic and treatment onset delays. METHODS: Various models for tumour volume changes with time are reviewed for estimating volume ranges at earlier times, using ranges of kinetic parameters. Statistical cure probability methods, using Poisson statistics with allowances for parameter heterogeneity, are also described to estimate the significance of treatment delays, as well as biological effective dose (BED) estimations of radiation effectiveness. RESULTS: The use of growth curves, based on parameters in the literature but with extended ranges, can identify a window of earlier times when such tumour volumes would be amenable to a cure based on the literature for curability with stage (and dimensions). Also, where tumour dimensions are not available in a post-operative setting, higher cure probabilities can be achieved if treatment had been given at earlier times. CONCLUSION: The use of radiobiological modelling can provide useful insights, with quantitative assessments of probable prior conditions and future outcomes, and thus be of assistance to a Court in deciding the most correct judgement. ADVANCES IN KNOWLEDGE: This study collates prior knowledge about aspects of radiobiology that can be useful in the accumulation of sufficient proof within medicolegal claims involving diagnostic and treatment days.

Ready for Germany's revised radiation rules?

The assessment of the benefit-risk ratio of investigational medicinal products (IMPs) and the approval of clinical trial applications (CTAs) conducted in the European Union (EU) is a remit of national competent authorities (NCAs) of the 28 member states. The aim of this article is to shed light on clinical studies for oncology drugs carried out in Germany which involve diagnostic radiation tests. The authorisation process surrounding diagnostic radiology accompanying clinical investigations and used for measuring IMP related treatment effects is not well understood. The procedure appears to be complicated because the scientific evaluation of the application is carried out by an independent agency, the Federal Office for Radiation Protection (Bundesamt für Strahlenschutz, BfS). To avoid delays and failures in conducting studies in Germany knowledge of the scope, procedural steps and associated timelines is crucial for project management purposes. Reliable planning is a pre-requisite for timely study initiation. Novelties of the recently implemented law and key aspects relevant to CTAs should facilitate obtaining BfS clearance. Integrating this additional regional requirement in drug development plans is of importance for timely commencement of multi-national clinical trials.

Ethics in the Legal and Business Practices of Radiation Oncology.

Ethical issues arise when a professional endeavor such as medicine, which seeks to place the well-being of others over the self-interest of the practitioner, meets granular business and legal decisions involved in making a livelihood out of a professional calling. The use of restrictive covenants, involvement in self-referral patterns, and maintaining appropriate comity among physicians while engaged in the marketplace are common challenges in radiation oncology practice. A paradigm of analysis is presented to help navigate these management challenges.

[The irradiation process]. / Processus du traitement par irradiation.

The purpose of this article is to describe the regulatory framework of the radiotherapy practice in France, the external irradiation and brachytherapy process and the guidelines for patient follow-up.

ASTRO APEx® and RO-ILS™ are applicable to medical malpractice in radiation oncology.

AIM: To analyze malpractice trials in radiation oncology and assess how ASTRO APEx® and RO-ILS™ apply to such cases. METHODS: The Westlaw database was reviewed using PICOS/PRISMA methods. Fisher's exact and Mann-Whitney U tests were used to find factors associated with outcomes. RESULTS: Of 34 cases identified, external beam was used in 26 (77%). The most common factors behind malpractice were excessive toxicity (80%) and lack of informed consent (66%). ASTRO APEx pillars and ROI-LS had applicability to all but one case. Factors favoring the defendant included statute of limitations (odds ratio: 8.1; 95% CI: 1.3-50); those favoring the plaintiff included patient death (odds ratio: 0.7; 95% CI: 0.54-0.94). CONCLUSION: APEx and RO-ILS are applicable to malpractice trials in radiation oncology.

[Approval procedures for clinical trials in the field of radiation oncology]. / Genehmigungsverfahren klinischer Studien im Bereich der Radioonkologie.

BACKGROUND AND PURPOSE: Application of ionizing radiation for the purpose of medical research in Germany needs to be approved by the national authority for radiation protection (Bundesamt für Strahlenschutz, BfS). For studies in the field of radiation oncology, differentiation between use of radiation for "medical care (Heilkunde)" versus "medical research" frequently leads to contradictions. The aim of this article is to provide principle investigators, individuals, and institutions involved in the process, as well as institutional review or ethics committees, with the necessary information for this assessment. Information on the legal frame and the approval procedures are also provided. METHODS: A workshop was co-organized by the German Society for Radiation Oncology (DEGRO), the Working Party for Radiation Oncology (ARO) of the German Cancer Society (DKG), the German Society for Medical Physics (DGMP), and the German Cancer Consortium (DKTK) in October 2013. This paper summarizes the results of the workshop and the follow-up discussions between the organizers and the BfS. RESULTS: Differentiating between "Heilkunde" which does not need to be approved by the BfS and "medical research" is whether the specific application of radiation (beam quality, dose, schedule, target volume, etc.) is a clinically established and recognized procedure. This must be answered by the qualified physician(s) ("fachkundiger Arzt" according to German radiation protection law) in charge of the study and the treatments of the patients within the study, taking into consideration of the best available evidence from clinical studies, guidelines and consensus papers. Among the important parameters for assessment are indication, total dose, and fractionation. Radiation treatments applied outside clinical trials do not require approval by the BfS, even if they are applied within a randomized or nonrandomized clinical trial. The decision-making by the "fachkundigem Arzt" may be supported on request by an opinion given by the DEGRO Expert Committee for clinical trials. CONCLUSION: An important aim for promoting clinical research and patient care in radiation oncology is to further professionalize planning and implementation of clinical trials in this field. Correct assessment, at an early stage, whether a trial needs to be approved by the BfS may reduce unnecessary costs and reduce the time needed for the approval procedure for those trials which need to be assessed by the BfS.