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Background and importance Despite a strict regulatory framework of clinical trials (CTs), few standardised tools are available. Our national survey conducted in 2020 demonstrated that all clinical research pharmacists (CRPs) have initiated a quality approach, which is however very heterogeneous and implemented more in university hospital centres and cancer centres, with a high activity level. New standardised tools for the investigational health products (IHPs) circuit would be of interest to 88/94 CRPs. The most useful tool was the self-assessment grid, according to 94% of CRPs. Thus we developed such a tool to manage specific risks of IHPs (complex protocols, assignment of treatment numbers, confusing packaging or labelling). Aim and objectives The aim of this work was create a standardised self-assessment grid to manage the specific risks of IHPs. Material and methods A pharmacy resident and two doctors of pharmacy of a regional working group defined a list of 66 evaluation criteria, mainly based on good clinical practices and on a professional guide of 2020 by the national university centre hospitals’ pharmacists commission. The criteria were divided into three main parts: general organisation and support functions; pharmaceutical management of CTs; and risk assessment and risk management. Then the grid was sent for validation to the 94 CRPs who had answered our national survey. The Delphi method was used and consensus among experts was defined by a satisfaction rate of >80% for relevance, clearness and accessibility. Results The first round of proofreading by 16 pharmacists led to a consensus of 85% (56/66) for the criteria, which were considered relevant, clear and assessable. This led to 36 modifications, 4 deletions and 2 additions of criteria. The second round by 8 pharmacists led to a consensus of 88% (60/68) for the criteria and resulted in 18 modifications and 2 deletions. There remained only one criterion considered irrelevant, which was deleted. These results led us to validate the final version of the grid, including 62 criteria. Conclusion and relevance This interactive tool will be disseminated in a free public online ‘CTs’ toolbox. It will provide a conformity score per process, allowing specific risks to be identified across the circuit of IHPs, by pharmacies in any healthcare facility, whatever the level of activity. References and/or acknowledgements Conflict of interest No conflict of interest

Summary Introduction In order to reduce outpatient-waiting delays in oncology departments, there has been development of new production processes. This study aimed to determine the impact of three different production organizations (nominative extemporaneous preparations, anticipated preparations, and non-nominative dose-banded preparations), with or without analytical control, on outpatient chemotherapy production times, in a French regional cancer center. Materials and methods For the three organizations, we measured the global and detailed production times of the preparations, during three distinct periods, and compared them. Results With an analytical control, anticipated nominative preparations and non-nominative dose-banded preparations reduced waiting delays by 29 and 19 minutes, respectively, compared to extemporaneous nominative preparations, and by 12 and 9 minutes, respectively, without analytical control. Discussion Anticipated nominative preparations and non-nominative dose standardized preparations allow reducing time dispensation, even with analytical control. Conclusion Implementing these new production processes could reduce outpatient-waiting delays in oncology departments.

Resume La melatonine est une petite molecule lipophile, secretee essentiellement dans la glande pineale. La synthese de cette hormone suit un rythme circadien avec un pic vers les 2–3 heures du matin. La melatonine possede de nombreux recepteurs dans l'organisme ce qui lui confere des fonctions multiples telles que la resynchronisation des rythmes biologiques, l'induction du sommeil, la vasoregulation mais aussi l'immunomodulation. De nombreuses experiences realisees dans ce domaine ont permis de decouvrir differentes interactions entre la melatonine et le systeme immunitaire, et surtout le lien qui existe entre la melatonine et la lutte anticancereuse de l'organisme via le systeme immunitaire. Des essais de phase II chez l'homme rapportent une diminution de la thrombocytopenie, une amelioration du taux de certaines cytokines et une augmentation de la reponse objective chez des patients atteints de cancer. Afin de confirmer et d'approfondir ces resultats, nous nous proposons de realiser un essai de phase II randomise melatonine versus placebo chez des patientes atteintes de cancers du sein metastatiques apres deux lignes de traitement.

International audience; La démence à corps de Lewy (DCL) est la deuxième cause de démence dégénérative du sujet âgé, dans les grandes séries autopsiques. Dans la réalité quotidienne des centres mémoire pourtant, la DCL représente une faible proportion des diagnostics cliniques, avec une forte disparité entre les centres. Plusieurs raisons peuvent rendre compte de la faible sensibilité du diagnostic de DCL : l’imprécision et la subjectivité des critères diagnostiques existants ; la place insuffisante donnée à certains signes non-moteurs (troubles du comportement en sommeil paradoxal, dysautonomie) ; enfin et surtout l’association quasi constante de la pathologie de Lewy à une pathologie de type Alzheimer, qui domine rapidement le phénotype clinique. À l’heure de l’essor des thérapies ciblées contre les agrégats protéiques, de nouvelles échelles cliniques permettant d’appréhender la coexistence de la pathologie de Lewy dans la maladie d’Alzheimer sont plus que jamais nécessaires.

Drugs pharmacokinetic control is a usual practice in case of flat continuous infusions. It enables among others, to modulate delivered doses when drug concentrations in blood appear too high. With chronotherapy, this possibility becomes more difficult because of sinusoidal outflows of infusion. We propose here a method that enables this follow-up, established through the study of 21 metastatic colorectal cancer patients, treated with a chronomodulated infusion of high dose 5-fluoro-uracil (5-FU) and folinic acid. This pharmacokinetic follow-up permitted the modelisation of 5-FU clearance and the calculation of an index, which was, in our study, correlated to the treatment response and also to main encountered toxicities.

International audience; To produce a radioactive-isotope (RI) beam with high spin alignment, we have developed a novel method, the two-step projectile-fragmentation (PF) method, that employs momentum-dispersion matching. An on-line experiment to produce 32Al from 48Ca via 33Al was performed at RIKEN RI Beam Factory. In the experiment, we succeeded in producing approximately 8% spin alignment in an RI beam of 32Al. In this paper, we focus on evaluating the magnitude of spin alignment realized in one-nucleon removal from 33Al

261 Background: Innovation is crucial in cancer care and access to innovation cannot be—only—economically ruled. We need new drugs, more effective and/or better tolerated to improve the care of our patients. In this context, we need new tools to evaluate the appropriateness of anticancer drugs prescriptions. In fact, the better the appropriateness, the better is the patient care, and the overall balance, including economically. Methods: A group of 9 pharmacists from university hospitals, general hospitals, and cancer centres joined under the umbrella of the European Fellowship for Pharmacists (EFP) association. The aim was to set up a common process in evaluating the appropriateness of anticancer drugs prescriptions (ADP), focusing on innovative drugs, but not only. Results: The backbone of our work was to put back the patient at the centre and not to focus on the costs as themselves. We defined a composite criterium called “value of an ADP” which included the costs of course in addition to several factors such as the existence of alternatives for a particular patient, the level of evidence from literature data, the existence of other indications, and several other items. First, a decision tree was elaborated, which allows systematic and standardized screening of ADP leading to early identification of ADP which do not necessitate thorough evaluation: prescription within the terms of either a market authorisation or a Temporary Therapeutic Protocol, or a Temporary Utilization Authorization (ATU), and not on a clinical trial. For the other prescriptions, an evaluation grid coupled to a score was set up. This APA Score (Anticancer Prescription Appropriateness) will allow to decide whether or not a ADP, in a particular clinical context and patient, should be judged as appropriate or not. Conclusions: At the time of this abstract: the evaluation grid has been discussed, modified, and validated with the participation of two clinical oncologists, specialized in Breast Cancer; the APA scoring is currently under testing by a team of methodologists and bio-mathematicians; and the grid and the APA Score will be tested in “real-life” within the departments of the people involved in the group by the end of 2011.

One of the areas of current interest in basic semiconductor research in Si-integrated optoelectronic devices. Among the several existing routes investigated to realize this aim, the use of semiconducting silicides is of high interest since such a technology would put silicon at the roots of both microelectronics and optoelectronics. Only a few silicides are believed to display semiconducting properties. FeSi2 with a direct gap of 0.89 eV appears as one of the most promising materials since epitaxy on silicon substrates (111) and (100) has been reported. In order to give some new insights on this epitaxial growth, which is a key point for any further development, the authors present results on the preparation of epitaxial FeSi2 thin films grown in a molecular beam epitaxy machine on (111) silicon wafers. By means of in situ real-time reflection high energy electron diffraction, the formation of various silicide phases has been observed during the solid phase epitaxy process.

In conjunction with the research program of the International Passamaquoddy Fisheries Board, approximately 10,000 drift bottles were released in the Quoddy Region of the Bay of Fundy in 1957 and 1958. Overall return of bottles was 25%. Results have been analyzed and surface drift inferred on monthly and seasonal bases. On the average, there is a counter-clockwise circulation in Passamaquoddy Bay, an outflow through Western Passage, a variable flow in Letite Passage, an outflow on the Campobello side and an inflow along the Deer Island side of Head Harbour Passage. In the outer Quoddy Region, there is evidence of a clockwise circulation around The Wolves, a variable flow in Grand Manan Channel, and a southerly movement off the east coast of Grand Manan Island.Wind speed and direction, which vary seasonally, appear very effective in altering the pattern of drift.