[Evaluation of healthcare product supply chain expenses in institutional studies - A case study at Toulouse's university hospital center]. / Évaluation des dépenses du circuit des produits de santé dans le cadre d'études institutionnelles ­ Étude de cas au CHU de Toulouse.

Clinical research faces complex and unpredictable budgetary challenges, despite its central role in the development of healthcare products. This retrospective study examines the estimated and actual costs of 13 trials managed by the Clinical Trials Coordinating Pharmacy at the University Hospital of Toulouse. It aims to assess the accuracy of estimates, identify trial-influencing events and identify budget adjustment variables. The results show that only two of the 13 studies stay within their initial estimates, with most exceeding their projected margins. Costs vary by area, with shipping and packaging in particular exceeding the initial budget, while distribution costs are more accurately estimated. Several factors influence costs, including study duration, centre locations, number of enrolments, product stability and protocol amendments. Extending the study duration leads to increased costs in all areas, while reducing the number of inclusions tends to be in line with the original budget. In conclusion, budget management in clinical trials is complex due to numerous influencing variables. Careful planning and consideration of the specifics of each trial are crucial for more accurate estimates and budget adherence. This study enhances the understanding of the financial challenges faced by institutional sponsors of clinical trials and contributes to the refinement of budgeting methods for future clinical trials.

Computer-Based Training for Cognitive Behavioural Therapy for Substance Use Disorder: A Randomized Controlled Trial Including Quantitative and Qualitative Health and Economic Outcomes: Formation informatisée pour la thérapie cognitivo-comportementale pour les troubles liés à l'usage de substances : un essai randomisé contrôlé y compris les résultats quantitatifs et qualitatifs en matière de santé et d'économie.

OBJECTIVES: Heavy alcohol and drug use is reported by a substantial number of Canadians; yet, only a minority of those experiencing substance use difficulties access specialized services. Computer-Based Training for Cognitive Behavioural Therapy (CBT4CBT) offers a low-cost method to deliver accessible and high-quality CBT for substance use difficulties. To date, CBT4CBT has primarily been evaluated in terms of quantitative outcomes within substance use disorder (SUD) samples in the United States. A comparison between CBT4CBT versus standard care for SUDs in a Canadian sample is critical to evaluate its potential for health services in Canada. We conducted a randomized controlled trial of CBT4CBT versus standard care for SUD. METHODS: Adults seeking outpatient treatment for SUD (N = 50) were randomly assigned to receive either CBT4CBT or treatment-as-usual (TAU) for 8 weeks. Measures of substance use and associated harms and quality of life were completed before and after treatment and at 6-month follow-up. Qualitative interviews were administered after treatment and at follow-up, and healthcare utilization and costs were extracted for the entire study period. RESULTS: Participants exhibited improvements on the primary outcome as well as several secondary outcomes; however, there were no differences between groups. A cost-effectiveness analysis found lower healthcare costs in CBT4CBT versus TAU in a subsample analysis, but more days of substance use in CBT4CBT. Qualitative analyses highlighted the benefits and challenges of CBT4CBT. DISCUSSION: Findings supported an overall improvement in clinical outcomes. Further investigation is warranted to identify opportunities for implementation of CBT4CBT in tertiary care settings.Trial Registration: https://clinicaltrials.gov/ct2/show/NCT03767907.

Evaluating a digital intervention targeting substance use difficultiesPlain Language SummaryWhy was the study done?Heavy alcohol and drug use is frequent in the Canadian population, although very few people have access to treatment. The digital intervention, Computer-Based Training for Cognitive Behavioural Therapy (CBT4CBT), may provide a low-cost, high-quality, and easily accessible method of treatment for substance use difficulties. Limited research on this digital intervention has been conducted in Canadian populations, and few studies thus far have evaluated participants' subjective experience using the intervention, along with the cost on the Canadian healthcare system.What did the researchers do?The research team recruited participants and provided access to either CBT4CBT or to standard care at a mental health hospital for 8 weeks. Participants were asked questions about their substance use and related consequences, quality of life, and thoughts on the treatment they received. Information regarding healthcare use and the cost to the healthcare system was also gathered.What did the researchers find?Participants in both groups improved with regards to their substance use, some related consequences, and psychological quality of life. Participants provided insight on the benefits and challenges of both types of treatment. It was also found that the CBT4CBT intervention was less costly.What do these findings mean?These findings support that adults receiving CBT4CBT and standard care both improved to a similar degree in this sample. Participant feedback may inform future studies of how best to implement this intervention in clinical studies. Future studies with larger samples are needed to further examine whether CBT4CBT can increase access to supports and be beneficial in the Canadian healthcare system.

Brain tumours: Non-invasive techniques to treat invasive pathologies.

Brain and other central nervous system tumours are cancers of poor prognosis, for which current therapeutic possibilities do not match the expectations regarding a curative objective. If the treatment of central nervous system tumours is so difficult, it is partly due to the blood-brain barrier and the blood-tumour barrier, which need to be crossed to access the tumour. Driven by these insufficient results, more and more techniques and technologies are being explored and are evolving: the progress of surgery and radiotherapy, the growing place of immunotherapies, or the apparition of new non-invasive techniques. The latter are those which interest us here, where promising advances are taking the leap to clinical trials. Nose-to-brain delivery, receptor-mediated transcytosis and micro-bubbles-associated focused ultrasounds are three therapeutic propositions with encouraging results regarding the improvement of drug access to the brain. Even though they might have their share of limits and adverse effects, benefit-risk balance looks promising, and they may appear as new options to treat patients in the future.

Optimizing pharmaceutical management of clinical trials.

OBJECTIVES: The clinical trials pharmacists have an essential role in managing the pharmaceutical part of interventional studies. The primary objective of this article was to provide a template for improving trials management for the growing number of studies without increasing personnel resources. MATERIAL AND METHODS: A retrospective study was conducted between 2016 and 2020 at the service of pharmacy at Lausanne University Hospital in Switzerland. RESULTS: The number of clinical trials (in progress) managed at the pharmacy increased from 77 to 115 (+49%) between 2016 and 2020. The majority of these studies were in oncology and were sponsored by industry. Therefore, different changes in routine tasks were decided during the 5 years term to meet the above challenge. These modifications allowed to improve pharmaceutical and administrative management of clinical trials, without increasing personnel resources. The management template was accepted by the sponsors, and no issues were mentioned by national and international audit authorities. CONCLUSION: Changes could be made in the routine practice of the clinical trials pharmacists to improve the management of studies, while the number of trials is increasing every year.

A "Patient Preference" Model of Recruitment for Research from Primary-Care-Based Memory Clinics: A Promising New Approach.

Recruiting persons with dementia for clinical trials can be challenging. Building on a guide initially developed to assist primary-care-based memory clinics in their efforts to support research, a key stakeholder working group meeting was held to develop a standardized research recruitment process, with input from patients, care partners, researchers, and clinicians. Discussions in this half-day facilitated meeting focused on the wishes and needs of patients and care partners, policy and procedures for researchers, information provided to patients, and considerations for memory clinics. Patients and care partners valued the opportunity to contribute to science and provided important insights on how to best facilitate recruitment. Discussions regarding proposed processes and procedures for research recruitment highlighted the need for a new, patient-driven approach. Accordingly, a key stakeholder co-designed "Memory Clinic Research Match" program was developed that has the potential to overcome existing barriers and to increase recruitment for dementia-related research.

[Treating high-risk myelodysplastic syndromes]. / Traitement des syndromes myélodysplasiques de haut risque.

Myelodysplastic syndromes (MDS) are clonal stem cell diseases that primarily affect the elderly. They are classified into low- and high-risk MDS according to prognostic scoring systems. In high-risk patients, treatment should aim to modify the course of the disease by preventing progression to acute myeloid leukemia, and thus improve survival. Stem cell transplantation remains the only curative treatment when possible, but this concerns a small minority of patients. Treatment is mainly based on hypomethylating agents (HMA). Our understanding of the biology of MDS has led to the development of drugs targeting key cellular processes such as apoptosis or post-translational modifications of proteins, the microenvironment and genetic mutations. Currently, new drugs are mainly tested in combination with HMAs in several clinical trials and, although none has yet obtained marketing authorization, many molecules seem promising.

[Treatments for rare ovarian tumors: What's new?] / Avancées thérapeutiques dans la prise en charge des tumeurs rares malignes ovariennes.

Even if each rare ovarian tumor (ROT) has a low incidence, the sum of all these entities represents almost the half of all ovarian neoplasms. Thus, development of dedicated clinical trial emerged as a prerequisite to improve their managements. Owing to the spreading of dedicated institutional networks and (supra)national collaborations, the number of clinical trials has increased the past few years, with different types of trials; while some focused on specific molecular features, others assessed innovative molecules. Furthermore, relevant randomized clinical trials were designed as a mean to position new treatment options. Currently, innovative molecular-driven trials, based on master protocol trials are emerging and may shed light towards the improvement of personalized medicine regarding ROT.

The Varieties of Psychedelic Expertise in 1960s Canada: The Psychiatrists behind the Addiction Research Foundation's Study of LSD Therapy.

In 1962, Ontario's Addiction Research Foundation launched the first double-blind randomized controlled trial of LSD therapy as a treatment for alcoholism. The study, which found that LSD was not effective, was heavily criticized by other therapists working with the drug. These critics argued that the Toronto researchers who carried out the study were biased against LSD and used an anti-therapeutic method that was destined to produce negative results. Instead of creating a comfortable and supportive environment, they stressed, the Toronto group restrained patients to a bed in a hospital ward, used an unusually large dose of LSD, and hardly provided any careful therapeutic support. Some even compared this method to a "form of torture." Historians have paid little attention to the study, mentioning it only as an example of flawed or naïve LSD therapy that contrasted with the more advanced "psychedelic" approach developed in Saskatchewan. In this paper, I take a closer look at the Toronto psychiatrists who carried out the study and created the unique method that was employed. I show that they were actually quite excited about LSD and were more sophisticated in their approach to its use than has been appreciated by historians and critics. In many ways, they had their own brand of LSD expertise that differed from that of the Saskatchewan group. Some of the problems with the ARF study, then, did not stem from negative bias or a lack of competency, but instead resulted from the awkward relationship between LSD therapy and controlled trials.

Résumé. En 1962, la Fondation pour la recherche sur la toxicomanie de l'Ontario lançait son premier test aléatoire et contrôlé en double aveugle de thérapie par le LSD pour traiter l'alcoolisme. L'étude, qui concluait que le LSD n'était pas efficace, a fait l'objet de critiques sévères de la part d'autres thérapeutes qui utilisaient cette drogue. Ces thérapeutes soutenaient que le groupe de recherche torontois avait un parti pris défavorable au LSD et avait employé des méthodes antithérapeutiques dans le but de produire des résultats négatifs. Ainsi, selon eux, au lieu de créer un environnement offrant un réel soutien, le groupe de Toronto attachait les patients à leur lit d'hôpital, employait des doses inhabituellement élevées de LSD et ne fournissait à peu près aucun soutien thérapeutique. La méthode a même été comparée à « une forme de torture ¼. Les historiennes et les historiens ont accordé peu d'attention à l'étude, sauf pour la citer comme exemple déficient ou naïf de thérapie par le LSD, en l'opposant à l'approche « psychédélique ¼ plus avancée mise au point en Saskatchewan. Dans cet article, je m'intéresse aux psychiatres qui ont mené l'étude de Toronto et conçu la méthode originale employée à la Fondation. Je montre que l'usage du LSD suscitait beaucoup d'enthousiasme dans le groupe et que son utilisation de cette drogue était plus complexe que l'ont reconnu jusqu'ici l'histoire et la critique. À plusieurs égards, le groupe de Toronto disposait de sa propre expertise en matière de LSD, différente de celle de ses collègues de la Saskatchewan. J'en conclus qu'une partie des problèmes attribués à l'étude conduite par la Fondation ne provient pas d'un préjugé défavorable ou d'un manque de compétence, mais plutôt des liens complexes entre la thérapie par le LSD et les essais cliniques.

[Radiation dose intensification for glioblastoma]. / Majoration de dose d'irradiation pour les glioblastomes.

Glioblastoma is the most common brain tumor in adults; its treatment includes surgical excision or biopsy followed by radio-chemotherapy. Even if radiotherapy increases the survival of all patients regardless of their age or their general condition, there are always sources of radioresistance, where relapses occur and therefore treatment fails. Indeed, these foci result in a local relapse, which is observed in 95% of cases in the irradiation fields. We will describe here the current approaches to overcome this radioresistance by dose escalation, without or with guidance by metabolic and functional imaging (dose-painting). We will detail several prospective trials including the French phase III trial, SPECTRO-GLIO, randomizing the use of an integrated boost guided by spectrometric magnetic resonance imaging and similar trials developed across the Atlantic. We will also discuss approaches using different PET markers as well as diffusion or perfusion magnetic resonance imaging.

[How to improve the surgical trials quality in daily practice]. / Comment améliorer la qualité méthodologique et l'adoption en routine des résultats des essais chirurgicaux ?

Surgical studies have specific issues, such as quality assurance on procedures, standardization of techniques, surgeon effect, timing of randomization, blinding respect or choice of the reference arm. All these difficulties conducted to criticism many trials, and lack of results implementation. Indeed, adherence to methodological guidelines is often poor. Twelve recommendations were recently issued by the JAMA surgery revue for good practice in surgical studies to improve the quality of surgical trials in general and surgical oncology. We detail here the main issues of surgical trials in gynaecological oncology surgery, as well as possibilities of improvement for future studies.

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study.

The objectives of our study were to understand researchers' current practices and perspectives on adverse event (AE) reporting in clinical trials of resistance training (RT) and to identify barriers and facilitators of AE reporting. We conducted web conference or telephone-based one-on-one semistructured interviews with 14 researchers who have published RT studies. We audio-recorded and transcribed the interviews and analyzed the data using the thematic framework method. Four themes were identified: (1) researchers lack guidance and/or motivation for rigorous AE reporting; (2) researchers who undertake AE reporting educate and value participants, use trained personnel, and implement standardized guidelines; (3) suboptimal implementation of existing AE reporting standards and the perception that available guidelines do not apply to exercise trials; and (4) acceptability and feasibility of an exercise-specific guide for AE reporting depend on its content and format. In conclusion, AE reporting methods in the field of exercise science do not align with best practice. Strategies to reduce inconsistent and suboptimal AE reporting in RT trials are urgently needed and could be based on the barriers and facilitators identified in this study.

Understanding the importance of the primary trial hypothesis: The randomized trial on the timing of ruptured aneurysm surgery.

BACKGROUND AND PURPOSE: The primary hypothesis of a trial must be explicitly formulated. The primary hypothesis is essential for the proper interpretation of trial results. METHODS: We review the seminal Finnish randomized trial on the timing of aneurysm surgery, and re-examine how trial results could have been interpreted at the time had a precise primary hypothesis been pre-specified. Finally, we compare the power of this single center randomized trial with the multicenter International Cooperative (observational) Study that examined the same clinical problem. RESULTS: Had the Finnish authors worked under a pragmatic hypothesis in favor of early surgery (within 3days) versus delayed surgery, the trial results could have been interpreted as conclusive. The randomized trial was more appropriate, more ethical, and more efficient than the inconclusive International Cooperative study. CONCLUSION: The randomized trial on the timing of aneurysm surgery was a landmark in neurovascular research. A precise pragmatic primary hypothesis is a crucial step in trial design and interpretation.

[Quality management of the experimental health products circuit in hospital pharmacies: National inventory and proposed standardised tools]. / Management de la qualité du circuit des produits de santé expérimentaux dans les pharmacies hospitalières : enquête nationale et développement d'outils standardisés.

OBJECTIVES: Carry out a national inventory of the current situation regarding the quality management of the investigational health products circuit, to develop adapted standardised tools. METHODS: A survey of 76 questions, developed by a regional working group, was conducted among clinical research pharmacists in French facilities. Tools were developed to meet the identified needs and validated by participating pharmacists, using the Delphi method. The consensus was defined by achieving a score above 80% on relevance, clarity and evaluability. RESULTS: Among 94 pharmacists participating in the survey, 88 were interested in standardised tools. The score for the implementation of a quality approach depended on the type of health facility (P<0.0005) and increased with the number of active trials (P<0.0005). All nine proposed tools were useful for over two thirds of pharmacists, but the self-assessment and audit grids have been prioritised. Indeed, only 26% of pharmacies carried out a prior risk assessment and 14% carried out internal audits. The review of both grids led to a consensus on 89% and 97% of the criteria respectively. The validated grids include 62 and 72 criteria respectively. DISCUSSION: The quality approach of the investigational health products circuit is heterogeneous in the participating centres, with a strong need for standardised tools. The two grids are relevant tools developed by and for professionals. CONCLUSION: The tools developed will enable to optimise the quality approach by identifying the non-conformities of the investigational health products circuit.

Etat des lieux de la règlementation des essais cliniques au Mali / State of play of the regulation of clinical trials in Mali

Objectif: L'objectif était de réaliser l'état des lieux de la réglementation des essais cliniques au Mali. Matériel et Méthodes: Il s'agissait d'une étude transversale descriptive réalisée du 1er septembre au 15 décembre 2019. Elle a consisté en une recherche documentaire et une enquête de terrain dans les centres de recherche, les comités d'éthique et les structures règlementaires du Mali. Résultats: En 2019, il y a eu 15 essais cliniques autorisés et réalisés par trois centres de recherche, dont 12 vaccinaux et 3 médicamenteux tous approuvés par un comité d'éthique. Le cadre juridique des essais cliniques est régi au Mali par deux textes dont l'un législatif et l'autre réglementaire. Ils prévoient l'autorisation, la suspension ou l'interdiction de la recherche biomédicale par le ministre en charge de la santé. Les insuffisances recensées sont relatives à la faible remontée et au manque d'évaluation des données de pharmacovigilance, la rareté des inspections des sites et surtout l'absence de comité technique d'évaluation règlementaire des dossiers à la Direction de la Pharmacie et du Médicament (DPM). Conclusion: Le renforcement du cadre juridique est, plus que jamais, nécessaire pour assurer la protection des droits, la sécurité et le bien-être des sujets de recherche dans un contexte de délocalisation croissante des essais cliniques vers nos pays

Objective: The objective was to take stockof the regulation of clinical trials in Mali. Material and Methods: This was a descriptive cross-sectional study carried out of the September 1 to December 15, 2019. It consisted of a literature search and a survey in research centers, ethics committees and regulatory structures in Mali. Results: In 2019, there were 15 clinical trials authorized and conducted by three research centers, including 12 vaccines and 3 drugs trials all approved by an ethics committee. The legal framework for clinical trials is governed in Mali by two texts, one legislative and the other regulatory. They provide for the authorization, suspension or prohibition of biomedical research by the minister in charge of Health. The shortcomings identified relate to the low recovery and lack of evaluation of pharmacovigilance data, the scarcity of site inspections and especially the absence of a technical committee for regulatory evaluation of files at the Pharmacy and Medicines Department (DPM). Conclusion: The strengthening of the legal framework is, more than ever, necessary to ensure the protection of the rights, safety and well-being of research subjects in a context of increasing relocation of clinical trials to our countries

Les indicateurs de l'alimentation du nourrisson et du jeune enfant prédicteurs de la malnutrition chez les enfants 6-23 mois dans la zone de santé de Kapolowe, Haut-Katanga, R D Congo / NA

Introduction. L'étude visait évaluer les indicateurs de l'alimentation du nourrisson et du jeune enfant liés à l'état nutritionnel dans la zone de santé de Kapolowe, province du Haut Katanga avant les essais cliniques. Matériel et méthodes. Nous avons conduit une étude descriptive transversale dans la communauté auprès des 568 couples mère-enfant 6-23 mois évalués sur les indicateurs nutritionnels associés à la malnutrition. Résultats. L'allaitement maternel optimal était observé chez 10,7% des couples mère-enfant et l'alimentation complémentaire adéquate bénéficiée par 5,5% des enfants. Presque 25,6% des ménages utilisaient des toilettes améliorées, 98,8% des ménages buvaient l'eau des sources protégées et 12,1% des mères pratiquaient un minimum de lavage de mains. Le premier aliment complémentaire donné à la moitié des enfants (46%) était importé, mais 60,3 % des mères utilisaient le mélange farine de maïs + huile + sucre comme aliment de complément. La prévalence de la malnutrition aiguë, de la malnutrition chronique et de l'insuffisance pondérale était respectivement de 11,9%, 37% et 26,8%. La malnutrition aiguë était associée à l'occupation de la mère, au niveau socio-économique du ménage, à la Religion de la mère, à la consultation prénatale suivie par la mère, au Minimum de Diversité Alimentaire, à l'allaitement maternel non optimal, aux infections récurrentes et au faible poids de naissance. L'insuffisance pondérale était associée au sexe, à l'occupation de la mère, au niveau socio-économique, à la religion de la mère, au minimum de diversité alimentaire, à l'allaitement maternel non optimal, aux infections récurrentes et au faible poids de naissance. La malnutrition chronique était associée au sexe, au niveau socio-économique,

Introduction. The aim of the study was to assess infant and young child feeding indicators related to nutritional status in the Kapolowe health zone, Haut Katanga province prior to the clinical trials. Material and methods. We conducted a descriptive cross-sectional study in the community among568 mother-child pairs 6-23 months of age assessed on nutritional indicators associated with malnutrition. Results. Optimal breastfeeding was observed in 10.7% of the mother-child pairs and adequate complementary feeding in 5.5%. Almost 25.6% of households used improved toilets, 98.8% of households drank water from protected springs and 12.1% of mothers practiced minimal hand washing,12.1% of mothers practiced minimal handwashing. The first supplementary food given to half of the children (46%) was imported food, but 60.3% of mothers used maize flour + oil + sugar as a complementary food. The prevalence of acute malnutrition, chronic malnutrition and under weight were 11.9%, 37% and26.8% respectively. Acute malnutrition was associated with the mother's occupation, household socio-economic level, mother's religion, prenatal consultation attended by the mother, minimum dietary diversity, non-optimal breastfeeding, recurrent infections, and low birth weigh. Underweight was associated with gender, maternal occupation, socio-economic level, maternal religion, minimum dietary diversity, non-optimal breastfeeding, recurrent infections and low birth weight. Chronic malnutrition was associated with gender, socio-economic level, minimum meal frequency, type of toilet used, non-optimal breastfeeding, recurrent infections, and low birth weight. Conclusion. The prevalence of malnutrition, in all its forms, is still very high and worrying among children aged 6-23 months. The feeding practices are predictors of it.

[State of play of the regulation of clinical trials in Mali]. / Etat des lieux de la reglementation des essais cliniques au Mali.

OBJECTIVE: The objective was to take stock of the regulation of clinical trials in Mali. MATERIAL AND METHODS: This was a descriptive cross-sectional study carried out of the September 1 to December 15, 2019. It consisted of a literature search and a survey in research centers, ethics committees and regulatory structures in Mali. RESULTS: In 2019, there were 15 clinical trials authorized and conducted by three research centers, including 12 vaccines and 3 drugs trials all approved by an ethics committee. The legal framework for clinical trials is governed in Mali by two texts, one legislative and the other regulatory. They provide for the authorization, suspension or prohibition of biomedical research by the minister in charge of Health. The shortcomings identified relate to the low recovery and lack of evaluation of pharmacovigilance data, the scarcity of site inspections and especially the absence of a technical committee for regulatory evaluation of files at the Pharmacy and Medicines Department (DPM). CONCLUSION: The strengthening of the legal framework is, more than ever, necessary to ensure the protection of the rights, safety and well-being of research subjects in a context of increasing relocation of clinical trials to our countries.

OBJECTIF: L'objectif était de réaliser l'état des lieux de la réglementation des essais cliniques au Mali. MATÉRIEL ET MÉTHODES: Il s'agissait d'une étude transversale descriptive réalisée du 1er septembre au 15 décembre 2019. Elle a consisté en une recherche documentaire et une enquête de terrain dans les centres de recherche, les comités d'éthique et les structures règlementaires du Mali. RÉSULTATS: En 2019, il y a eu 15 essais cliniques autorisés et réalisés par trois centres de recherche, dont 12 vaccinaux et 3 médicamenteux tous approuvés par un comité d'éthique. Le cadre juridique des essais cliniques est régi au Mali par deux textes dont l'un législatif et l'autre réglementaire. Ils prévoient l'autorisation, la suspension ou l'interdiction de la recherche biomédicale par le ministre en charge de la santé. Les insuffisances recensées sont relatives à la faible remontée et au manque d'évaluation des données de pharmacovigilance, la rareté des inspections des sites et surtout l'absence de comité technique d'évaluation règlementaire des dossiers à la Direction de la Pharmacie et du Médicament (DPM). CONCLUSION: Le renforcement du cadre juridique est, plus que jamais, nécessaire pour assurer la protection des droits, la sécurité et le bien-être des sujets de recherche dans un contexte de délocalisation croissante des essais cliniques vers nos pays.

Nouvelles stratégies thérapeutiques dans les cancers du sein HER2-surexprimé: New therapeutic strategies in HER2-positive breast cancer.

Breast cancer with HER2-amplification accounts for 20 % of breast cancers. The management of patients has dramatically changed with the advent of anti-HER2 treatment, especially the monoclonal antibodies since 2000 in the metastatic and (neo)-adjuvant setting, leading to an improvement of patient outcomes. If therapeutic arsenal has been gradually enhanced with the targeting of HER receptors family, resistances to these treatments are observed, hence the development of new therapeutic strategies. This review provides an updated look of novel therapeutic strategies in HER2-positive breast cancer, as well as future perspectives, both in the adjuvant and metastatic setting.

[Salvage radiotherapy after prostatectomy - what do do in case of elevated post operative PSA or macroscopic relapse?] / Radiothérapie de rattrapage après prostatectomie radicale : que faire en cas de concentration de PSA postopératoire élevée persistante ou de récidive locale macroscopique ?

The management of the postoperative biological relapse of prostate cancer is most often based on salvage radiotherapy (RT) and a variable duration of hormone therapy (HT) in addition. The indications for RT±HT become more consensual for the adjuvant postoperative situation or in the event of a rising PSA level after a period where an undetectable PSA level was achieved. On the other hand, in the event of detectable PSA immediately postoperatively or in the event of a biological recurrence with macroscopic relapse in the prostate bed seen on conventional imaging assessment, the treatment options are still being evaluated. This article will describe these 2 situations and their current management but also will come through assessments with the contribution of modern imaging and new treatment options in terms of RT dose and RT±HT combination.

Agreement of primary outcomes in chiropractic-related clinical trials registered in clinicaltrials.gov with corresponding publication.

INTRODUCTION: Previous analysis of registered clinical trials has found a number of protocols result in changes in the registered primary outcome measures. This investigation determined if reported primary outcomes in chiropractic-related clinical trials registered in clinicaltrials.gov match their published results. Additionally, we assessed secondary outcomes, publication status and whether raw data were posted to the registry. METHODS: Clinicaltrials.gov was searched for chiropractic-related trials and having a completed status. If the study was published, outcome measures were compared between the clinicaltrials.gov entry and the published paper to assess for consistency. RESULTS: Within clinicaltrials.gov 171 chiropracticrelated protocols were identified with 102 of those published (59.6% publication rate). Ninety-two of the published papers (90.2%) had agreement between their primary outcome and the entry on clinicaltrials.gov and 82 (80.4%) agreed with the secondary outcomes. CONCLUSION: A modest rate of agreement between clinicaltrials.gov entries and the published papers was found. While chiropractic-related clinical trials are fewer compared to medical trials, chiropractic-related research has a substantially better rate of primary and secondary outcome concordance with registered protocols.

INTRODUCTION: En examinant des essais cliniques enregistrés, on s'est rendu compte qu'un certain nombre de protocoles faisaient varier les résultats principaux. On a mené une étude pour savoir si les résultats primaires d'essais cliniques sur la chiropratique enregistrés sur clinicaltrials.gov correspondaient à ceux publiés. On a aussi examiné les résultats secondaires, l'état de publication et cherché à savoir si les données brutes étaient publiées dans le registre. MÉTHODOLOGIE: Dans la base de données Clinicaltrials.gov, on a repéré des essais cliniques sur la chiropratique qui étaient terminés. Lorsque l'essai clinique avait été publié, on a comparé les résultats au moment de son enregistrement sur clinicaltrials.gov à ceux parus dans des publications pour savoir s'ils concordaient. RÉSULTATS: Sur le site clinicaltrials.gov, on a trouvé 171 études sur la chiropratique, dont 102 avaient été publiés (taux de publication:59,6 %). Pour quatrevingt-douze publications (90,2 %), on a observé une concordance entre les résultats primaires au moment de l'enregistrement sur clinicaltrials.gov et 82 (80,4 %) et les résultats secondaires. CONCLUSION: On a observé un taux modeste de concordance entre les données à l'enregistrement sur clinicaltrails.gov et les données publiées. Les essais cliniques sur la chiropratique sont moins nombreux que des essais cliniques de médicaments. Mais le taux de concordance entre les résultats primaires et les résultats secondaires était considérablement plus élevé lorsque les protocoles de recherches sur la chiropratique sont enregistrés.