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Background/Aims It is increasingly recognised that reliance on frequent site visits for monitoring clinical trials is inefficient. Regulators and trialists have recently encouraged more risk-based monitoring. Risk assessment should take place before a trial begins to define the overarching monitoring strategy. It can also be done on an ongoing basis, to target sites for monitoring activity. Various methods have been proposed for such prioritisation, often using terms like ‘central statistical monitoring’, ‘triggered monitoring’ or, as in the International Conference on Harmonization Good Clinical Practice guidance, ‘targeted on-site monitoring’. We conducted a scoping review to identify such methods, to establish if any were supported by adequate evidence to allow wider implementation, and to guide future developments in this field of research. Methods We used seven publication databases, two sets of methodological conference abstracts and an Internet search engine to identify methods for using centrally held trial data to assess site conduct during a trial. We included only reports in English, and excluded reports published before 1996 or not directly relevant to our research question. We used reference and citation searches to find additional relevant reports. We extracted data using a predefined template. We contacted authors to request additional information about included reports. Results We included 30 reports in our final dataset, of which 21 were peer-reviewed publications. In all, 20 reports described central statistical monitoring methods (of which 7 focussed on detection of fraud or misconduct) and 9 described triggered monitoring methods; 21 reports included some assessment of their methods’ effectiveness, typically exploring the methods’ characteristics using real trial data without known integrity issues. Of the 21 with some effectiveness assessment, most contained limited information about whether or not concerns identified through central monitoring constituted meaningful problems. Several reports demonstrated good classification ability based on more than one classification statistic, but never without caveats of unclear reporting or other classification statistics being low or unavailable. Some reports commented on cost savings from reduced on-site monitoring, but none gave detailed costings for the development and maintenance of central monitoring methods themselves. Conclusion Our review identified various proposed methods, some of which could be combined within the same trial. The apparent emphasis on fraud detection may not be proportionate in all trial settings. Despite some promising evidence and some self-justifying benefits for data cleaning activity, many proposed methods have limitations that may currently prevent their routine use for targeting trial monitoring activity. The implementation costs, or uncertainty about these, may also be a barrier. We make recommendations for how the evidence-base supporting these methods could be improved.

This article presents the history and structure of the school of clinical trials monitors in Russia, the reasons for its opening in 2011, as well as the results of a survey of graduates. The authors discuss in detail what tasks they faced in creating a high-quality, modern, interactive educational program that is sustainable in the long term. Shows the important role of collaboration between academic institutions and business companies directly involved in clinical research on a daily basis. The structure of the course is presented, as well as teaching materials and electronic systems and technologies are used. Separately, the experience of operating a school during the COVID-19 pandemic is given, an analysis of the course functioning in fully online format, the positive and negative aspects of this approach. The second part of the article presents the results of a survey of graduates of the course for 9 years: from their satisfaction with training, to their further professional career (a total of 8 questions). In conclusion, the authors present their personal attitude to this educational project.

This good clinical practice paper provides an overview of the current evidence around second stage care, highlighting the challenges and the importance of maintaining high‐quality, safe, and respectful care in all settings. It includes a series of recommendations based on best available evidence regarding length of second stage, judicious use of episiotomy, and the importance of competent attendants and adequate resource to facilitate all aspects of second stage management, from physiological birth to assisted vaginal delivery and cesarean at full dilatation. The second stage of labor is potentially the most dangerous time for the baby and can have significant consequences for the mother, including death or severe perineal trauma or fistula, especially where there are failures to recognize and repair. This paper sets out principles of care, including the vital role of skilled birth attendants and birth companions, and the importance of obstetricians and midwives working together effectively and speaking with one voice, whether to women or to policy makers. The optimization of high‐quality, safe, and personalized care in the second stage of labor for all women globally can only be achieved by appropriate attention to the training of birth attendants, midwives, and obstetricians. FIGO is committed to this aim alongside the WHO, ICM, and all FIGO’s 132 member societies., This paper provides an overview of the current evidence in best practice for second stage care, highlighting the challenges of maintaining high‐quality, safe, and respectful care in all settings.

In 2010 Largent, Wendler and Emanuel proposed the ‘consent substitute model’ for emergency research with incapacitated participants. The model provides a means to enroll participants in emergency research without consent, if five conditions are met: (1) the research addresses the patients’ urgent medical needs (2) the risk‐benefit ratio is favorable (3) there are no known conflicts with patients’ values or interests (4) cumulative net risk is minimal and (5) consent is given as soon as possible. We review national and international ethics laws, regulations and guidelines to determine (a) whether they accord with the consent substitute model’s five conditions and (b) the level of congruence across these documents. We find that only one document meets all five conditions and that there is significant disparity among the documents, particularly between national and international ones. These differences may have stymied international collaboration in emergency research. We recommend that the two international documents used most, the International Council for Harmonisation’s Guideline for Good Clinical Practice and the World Medical Association’s Declaration of Helsinki, are revised to include more specific provisions on emergency medical research.

Although one of the first pieces of legislation to address ethical issues in clinical trials was drawn up following the findings from the Nuremberg Trials, only in the more recent clinical research have the principles of beneficence, non-maleficence, autonomy and justice been considered and informed consent plays a major role. In the UK, the National Research Ethics Service and the Medicines and Healthcare Products Regulatory Agency require compliance with Good Clinical Practice. Patients are unlikely to participate in, or clinicians consent their patients to, trials where they do not feel safe or protected - data and safety monitoring assess for loss of clinical equipoise thus ensuring the most efficacious treatment is always available. Honesty and trust are crucial and place an obligation on investigators to disseminate even less favourable trial results, with the ultimate aim being partnerships between patients, their families, and those delivering the research which are mutually beneficial and respectful.

Good clinical practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. Before the start of a clinical trial, investigators commit to perform the research in accordance with GCPs, regulatory dispositions and protocol. The sponsors are responsible for investigators' selection and for controlling their skills. Whereas industrial sponsors systematically require a certificate of GCP training, academic sponsors seem to be less demanding. We have carried out two surveys between April and June 2018. A first questionnaire was sent to the 40 French academic directions of clinical research and innovation in order to determine their requirements about the GCP training of the investigators participating in their trials. The second questionnaire was transmitted to physicians of the "Bretagne recherche clinique hospitaliere network": Rennes, Saint-Malo, Saint-Brieuc, Vannes, Lorient and Pontivy hospitals, in order to determine the GCP certification rate, and their needs in terms of clinical research training. Twenty-eight (70%) directions of clinical research answered the first survey, among which 18 (64%) required systematically the investigators' GCP certification in case of category 1 interventional studies. This rate decreased for category 2 (50%) and non-interventional category 3 (18%) studies. A total of 345 physicians answered the second survey, among which 263 (76%) had already been clinical trial investigators. However, only 29% of all physicians and 54% of those who had been principal investigator were certified for GCP training. These results support the need for large campaigns of GCP training in public hospitals.

Tertiary care centers in Russia were subdivided on two categories during recent COVID-19 outbreak and counter infection measures, undertaken by the government. In the first category were the centers, providing medical care solely to the COVID-19 cases; in second hospitals worked with all other cases, excluding COVID-19 ones. COVID-19-oriented centers are taking strict protective measures against the infection, with medical and other staff working in the individual biohazard protection suits, full disinfection at the border between the clean and unclean zones, thorough medical supervision over the health of all the employees. In the second category centers observation regime was implemented, with the obligatory medical masks and disposable lab coats. wearing, as well as thorough medical supervision over the health of all the employees. These different regimes determine some features of clinical neurophysiology in these centers. In the case of electroencephalography (EEG) main point is the real need of the procedure in the certain clinical situation. In COVID-19 cases all functional tests should be excluded from the protocol; procedure have to be performed in shortest time possible. EEG is performed according to good clinical practice and consensus protocols with thorough and strict disinfection of the devise and all cables, caps etc. If the patient was in the prone position during the procedure, this should be noted for the neurophysiologist. Conduction studies may be performed in the possible coronavirus-associated Guillain–Barré syndrome or critical illness polyneuropathies. Needle myography may be needed only in the rare cases of coronavirus-associated acute myelitis, in all other cases conduction studies are more than enough.

Clinical trials play an important role in improvement of quality on healthcare practice. Good clinical practice is a backbone of conductance of trials. A lack of knowledge may translate to a negative perception towards clinical trials. The study aims to evaluate the awareness of clinical trials among undergraduate dental students in a private dental institute. We have quantified the knowledge and perception of clinical trials by a structured validated questionnaire. The questionnaire was administered to dental students from first year undergraduate to third year Postgraduate. The percentage of questions answered were calculated and tabulated in the excel sheet. Data were analysed using SPSS statistical software and the chi-square test was done. P valve was set as 0.05 as a level of significance. From statistical analysis, postgraduate students (59.2%) had better knowledge than undergraduate students (40.8%). Around (46.7%) had been involved in clinical trial training. Within the limitations of current study, students pursuing postgraduate had a better knowledge of clinical trial methodology than compared to undergraduate students.

Introduction Hypothermia is a well-known risk of the perioperative period and considered a preventable effect of anesthesia care. Nevertheless, it is not fully controlled, causing a number of adverse outcomes following surgical operations and thus increasing length of stay in hospital and treatment costs. The aim of this study was to assess the budget impact (BI) of the implementation of proactive strategies to prevent inadvertent perioperative hypothermia (IPH) in surgical patients in Italy, as recommended by international guidelines and by a good clinical practice (GCP) guideline of the Italian Society of Anesthesia, Analgesia, Reanimation, and Intensive Care. Methods BI was calculated over a 3-year period from the perspective of the Italian National Health Service (NHS). Model inputs were extracted from national literature when available and otherwise from international sources. The reference analytic model was based on the cost-effectiveness analysis of the National Institute for Health and Care Excellence clinical guidance 65. Estimates were based on assessments made about current malpractice in Italy and on a hypothesis of how future practice might change by implementing the GCP. Model output included overall BI results, variations in the number of warmed patients, medical-device average costs and use of mix. Results The base-case estimate quantified a decrease of 35% in extra days of hospital stay due to IPH and a net BI of -€60.92 million. Conclusion Increasing protocol adoption for preventing IPH would lead to both clinical advantages and significant savings for the NHS. Its large diffusion in Italian hospitals is thus desirable.

The expansion of indications for assisted reproductive technology has led to significant implications for assisted reproductive technology (ART) programs worldwide. More than 7 million children in the world were born using ART. Modern clinical practice in the field of reproductive sciences is aimed not only at increasing the effectiveness, but also at the safety of treatment. ART, like any other type of therapy, may be combined with negative side effects. Both the correct prediction of the risks associated with treatment and a personalized approach ensure the absolute safety of infertility treatment using in vitro fertilization. In this regard, over the past decade, a number of new research approaches have been noted that use ART methods integrated into clinical practice: cycle segmentation with subsequent embryo transfer and the elective transfer of one embryo. New approaches provide a control in relation to ovarian stimulation and a reduction in the number of transferred embryos, which helps to minimize primarily adverse perinatal outcomes. Predicting the risks and outcomes of treatment using mathematical modeling is the application of good clinical practice.

The growth of the available transcatheter treatment approaches for the mitral and tricuspid position was accompanied by important clinical trials and studies through the last years. The selection of appropriate candidates for transcatheter techniques requires significant insight into anatomical limitations of each patient undergoing clinical evaluation. Furthermore, technological characteristics of the available devices, and risks and benefits of each potential therapy, play the most important role in a physician's decision. This knowledge should be valuable to both interventional cardiologists and researchers. This paper aims to offer a concise overview of the technological advances in this field of Interventional Cardiology. Trials and studies announced at the major interventional cardiology congresses during 2018 and 2019 were systematically reviewed. Moreover, a literature search in PubMed for the same period identified an amount of publications eligible for inclusion, based on their relevance to the subject, and their potential impact on current guidelines of good clinical practice.

The International Council for Harmonisation (ICH) E6(R2) (International Council for Harmonisation (ICH). ICH harmonised guideline: integrated addendum to ICH E6(R1): guideline for good clinical practice E6(R2). 2016. https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf. Accessed 5 Dec 2019) introduced Quality Tolerance Limits (QTLs) to the industry, and in doing so, modernized quality control for clinical trials. QTLs provide measured feedback on clinical trial parameters previously only used by statistical and clinical functions to track trial progress toward endpoints. Elevating these measures as part of the Quality Management System (QMS) provides greater visibility across clinical trial functions and the enterprise as well as to measures that are important indicators of the state of participant protection and reliability of trial results. In support of this new requirement, TransCelerate developed a framework to guide industry sponsors and their agents in implementing QTLs. This QTL Framework is intended to aid industry’s ability to improve the quality of clinical research through the implementation of QTLs in a way that helps protect trial participants and reliability of trial results while meeting Health Authority (HA) expectations. The framework is intended to maximize efficiency and minimize confusion in the implementation of QTLs. The framework includes proposed approaches for implementation of QTLs for a clinical trial as defined in Section 5.0.4 and 5.0.7 of ICH E6(R2) (International Council for Harmonisation (ICH). ICH harmonised guideline: integrated addendum to ICH E6(R1): guideline for good clinical practice E6(R2). 2016. https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf. Accessed 5 Dec 2019) and considerations for setting thresholds.

Background: Most patients with perianal Crohn's disease fistulas receive medical treatment with anti-TNF. So far, outcomes of anti-TNF have not been directly compared to chronic seton drainage or surgical closure. We hypothesized that chronic seton drainage would result in fewer re-interventions compared to anti-TNF and surgical closure. Methods: This multicentre, randomised trial was performed in 19 European centres. Patients with high perianal Crohn's fistulas with a single internal opening were randomly assigned in a 1:1:1 ratio to chronic seton drainage, long-term anti-TNF therapy, or surgical closure using a central web-based system without stratification. Patients were analysed according to the intention-to-treat principle. The primary outcome was the cumulative number of patients with fistula-related re-intervention(s) at 1.5 year. Patients refusing randomisation due to a specific treatment preference were included in a parallel prospective PISA registry cohort. Findings: Between September 14, 2013 and November 20, 2017, 44 of the 126 planned patients were randomised. The study was stopped by the data safety monitoring board because of futility. Seton treatment was associated with the highest re-intervention rate (10/15, versus 6/15 anti-TNF and 3/14 surgical closure patients, P = 0·02). No substantial differences in perianal disease activity and quality of life between the three treatment groups were observed. Interestingly, in the PISA prospective registry (n = 50), inferiority of chronic seton treatment was not observed for any outcome measure. Interpretation: The results imply that chronic seton treatment should not be recommended as the sole or superior treatment for perianal Crohn's fistulas. However, the statistical inferiority of seton treatment should be interpreted with caution, due to the crucial aspects of small numbers and as this inferiority could not be confirmed in the PISA registry data. Trial Registration Number: The trial is registered with the Dutch Trialregister.nl number NTR4137. Funding Statement: The Netherlands Organization for Health Research and Development and the Crohn and Colitis Foundation. Declaration of Interests: KAW, EJdG, MES, MGD, MFG, JMJ, AP, SAvT, DDZ, KFB, JvdB, MWM, WAB, and CJB have no conflicts of interests to declare. GRD’H has served as advisor for Abbvie, Ablynx, Allergan, Amakem, Amgen, AM Pharma, Arena Pharmaceuticals, AstraZeneca, Avaxia, Biogen, Bristol Meiers Squibb, Boerhinger Ingelheim, Celgene/Receptos, Celltrion, Cosmo, Covidien/Medtronics, Echo Pharmaceuticals, Eli Lilly, Engene, Ferring, DrFALK Pharma, Galapagos, Genentech/Roche, Gilead, Glaxo Smith Kline, Gossamerbio, Hospira/Pfizer, Immunic, Johnson and Johnson, Lycera, Medimetrics, Millenium/Takeda, Mitsubishi Pharma, Merck Sharp Dome, Mundipharma, Nextbiotics, Novonordisk, Otsuka, Pfizer/Hospira, Photopill, Prometheus laboratories/Nestle, Progenity, Protagonist, Robarts Clinical Trials, Salix, Samsung Bioepis, Sandoz, Seres/Nestle, Setpoint, Shire, Teva, Tigenix, Tillotts, Topivert, Versant and Vifor; received speaker fees from Abbvie, Biogen, Ferring, Johnson and Johnson, Merck Sharp Dome, Mundipharma, Norgine, Pfizer, Samsung Bioepis, Shire, Millenium/Takeda, Tillotts and Vifor. CYP has served as adviser for Abbvie, Takeda, and Pliant, declares a grant from Takeda, and received speaker’s fees from Abbvie, Tillotts, and Takeda. KBG has served as speaker and/or advisor for Amgen, AbbVie, Biogen, Boehringer Ingelheim, Ferring, Hospira, MSD, Pfizer, Samsung Bioepis, Sandoz, Takeda and Tigenix. AS has served as speaker and/or advisor for Takeda. SD has served as a speaker, a consultant and an advisory board member for Abbvie, Ferring, Hospira, Johnson & Johnson, Merck, Millennium Takeda, Mundipharma, Pfizer, Tigenix, UCB Pharma, and Vifor. Ethics Approval Statement: The study was performed in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice guidelines, and is reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The trial received central approval from the medical ethics committee at the Amsterdam UMC, location AMC, and from the corresponding committees in all participating centres.

Purpose The current scenario of the COVID-19 pandemic has forced dentists to prepare themselves by updating their knowledge and receive training to face the present and after effects of COVID-19. The present survey was thus conducted to assess the knowledge, risk perception, attitude, and preparedness of the dentists in India about COVID-19. Materials and methods A cross-sectional online survey was carried out among registered dentists in India. A self-administered, anonymous, questionnaire comprising of 25 close-ended questions was circulated to gather the relevant information. A total of 765 dentists submitted a response, out of which 646 complete responses were included in the statistical analysis. Pearson's Chi-square test was used for inter-group statistical comparison. Results The majority (80.8%) of the dentists had a fair knowledge about the characteristics of COVID-19. Nearly 60.7% and 49.7% of the dentists had taken infection control training and special training for COVID-19, respectively. Nearly 50% of the dentists had the perception that COVID-19 is very dangerous. Only 41.8% of the dentists were willing to provide emergency services to patients. Most of the dentists had an opinion that there is a need to enhance personal protective measures. During the survey, it was found that varied technological advances are offered to dentists to ensure good clinical practice. They also concurred that there was a need to standardize the tools and measures available to carry out dental practices. Conclusion In the present study, Indian dentists have presented satisfactory knowledge with adequate preparedness as the majority of them had a fair level of knowledge with significantly higher knowledge among female respondents and those with post-graduation studies. Dentists should make judicious utilization of all the precautionary measures to safely practice dentistry. As we are going through an evolutionary phase where new advances are expected to evolve, dentists will definitely emerge successfully out from the crisis of the COVID-19 pandemic.

The present, updated document describes the fourth iteration of recommendations for the hepatic use of contrast enhanced ultrasound (CEUS), first initiated in 2004 by the European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB). The previous updated editions of the guidelines reflected changes in the available contrast agents and updated the guidelines not only for hepatic but also for non-hepatic applications.The 2012 guideline requires updating as previously the differences of the contrast agents were not precisely described and the differences in contrast phases as well as handling were not clearly indicated. In addition, more evidence has been published for all contrast agents. The update also reflects the most recent developments in contrast agents, including the United States Food and Drug Administration (FDA) approval as well as the extensive Asian experience, to produce a truly international perspective.These guidelines and recommendations provide general advice on the use of ultrasound contrast agents (UCA) and are intended to create standard protocols for the use and administration of UCA in liver applications on an international basis to improve the management of patients.

Human papillomavirus (HPV) vaccination offers an excellent prospect for the primary prevention of cervical cancer. The bivalent and quadrivalent vaccines are both available in India. The nonavalent vaccine is licensed but not yet available. However, there still remain controversies regarding the vaccination of older women, immunocompromised females and other special groups. To provide recommendations for HPV vaccination in India. The Federation of Obstetric and Gynecological Societies of India (FOGSI) convened an expert group on cervical cancer prevention to formulate good clinical practice recommendations (GCPR) with respect to vaccine efficacy and safety, target groups, optimal timing and dosing schedules. HPV vaccines are licensed for females aged 9-45 years in India and have been seen to be safe and effective. FOGSI recommends HPV vaccination of all girls15 years of age as the best target group, in whom two-doses at an interval of 6 months, extendable to 18 months, are recommended. Three-doses are recommended in girls15 years of age, immunocompromised persons and sexual assault survivors. Older women and women with abnormal screening results may be vaccinated with an understanding that vaccination does not protect against already acquired infections and screening has to continue. Single-dose vaccination results are promising. Increased awareness is required to reduce vaccine hesitancy. HPV vaccination should be the priority to achieve the elimination of cervical cancer. The introduction of affordable HPV vaccines and reduced dose schedules will improve coverage.

Objective Creating an environment that supports conditions of routine clinical practice and enables an effectiveness trial design with a pre-licensed medicine is extremely challenging. Here, we summarise our experiences and achievements with engaging and mobilising community pharmacies in and around Salford, United Kingdom, in the Phase III effectiveness Salford Lung Studies (SLS). Methods This article provides the authors’ personal experiences and viewpoints on community pharmacy involvement in the SLS. Key findings More than 130 community pharmacies were enabled, and >2500 pharmacy staff trained, for involvement in the SLS. Key to community pharmacy participation in the SLS was the formation of the SLS Pharmacy Steering Group (PSG), contributing to study oversight, and the development of a pharmacy standard operating procedure document, the major principle of which was to ensure minimum disruption to the normal medicine dispensing process while ensuring compliance with regulations, guidelines, good clinical practice and requirements for pharmacovigilance. The high level of commitment and collaboration of community pharmacy in the SLS demonstrated a willingness to work together and take on additional and novel roles beyond their everyday commercial functions for the benefit of patients, despite normally competing for prescription business. Conclusions The involvement and integration of community pharmacy as a key partner in the SLS was pivotal in securing the delivery of these world-first clinical effectiveness studies. To our knowledge, this has not been previously achieved in a study of a pre-licensed maintenance therapy for a common disease in primary care.

Laser surgery is becoming an increasingly efficacious and customizable treatment modality for the management of pediatric vascular lesions. Proper use requires a thorough understanding of the scientific principles of laser surgery and knowledge of the various lasers available. Moreover, each laser has a multitude of settings that can be employed to properly target the lesion at hand. Each patient will present with unique challenges and variations in the presentation of their vascular lesion. This requires understanding of the most effective laser to use for each lesion and the factors that may alter the desired device settings. Using key search terms, a literature search was conducted on laser surgery for pediatric vascular lesions using PubMed/MEDLINE and Embase for articles published in English or French. Ultimately, 52 articles met our search criteria. The laser indications, limitations, and settings utilized for each type of vascular lesion were compiled for the purposes of this summative review. Laser surgery is an effective and appropriate option for the treatment of certain pediatric vascular lesions. Knowledge of optimal device parameters in every setting is essential to good clinical practice.

When conducting clinical trials under COVID-19 pandemic, protocol deviations and/or protocol violations are inevitably encountered due to possible environment change which may have an impact on the accuracy and reliability of clinical evaluation of the test treatment under investigation. Protocol deviations and/or violations include, but are not limited to, eligibility criteria, testing procedure, dose and dose regiment, treatment duration and clinical operation of the intended trial. FDA published guidance in March 2020 to assist investigators and institutional boards (IRBs) in assuring the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial integrity during the COVID-19 pandemic. The purpose of this article is to proposal methods for statistical evaluation in terms of (i) possible shift in target patient population and (ii) assessment of reproducibility of clinical studies conduct under COVID-19 pandemic environment. The proposed methods can be used to determine whether the clinical results of the intended trials are acceptable from both statistical and regulatory perspectives.

Antibiotic resistance represents a key challenge of the 21st century. Since the pipeline of new antibiotics in development is limited, the introduction of alternative antimicrobial strategies is urgently required. Bacteriophage therapy, the use of bacterial viruses to selectively kill bacterial pathogens, is re-emerging as a potential strategy to tackle difficult-to-treat and multidrug-resistant pathogens. The last decade has seen a surge in scientific investigation into bacteriophage therapy, including targeting orthopaedic-device-related infections (ODRIs) in several successful case studies. However, pharmacological data, knowledge on the interplay with the immune system and, especially in ODRIs, the optimal local application strategy and treatment outcomes remain scarce. The present review reports the state-of-the-art in bacteriophage therapy in ODRIs and addresses the hurdles in establishing bacteriophage therapy under good clinical practice guidelines. These hurdles include a lack of data concerning bacteriophage production, processing, administration and dosing, as well as follow-up clinical monitoring reports. To overcome these challenges, an integrated clinical approach is required, supported by comprehensive legislature to enable expansive and correctly implemented clinical trials. ispartof: EUROPEAN CELLS & MATERIALS vol:39 pages:193-210 ispartof: location:Switzerland status: published

Contemporaneous and thorough record keepingfor conscious sedation in dentistry is goodclinical practice; it is necessary to ensure patientsafety and helps protect patients and clinicians(medicolegally). Clinicians providing a sedationservice should be familiar with guidelines andtheir implementation. Record keeping forconscious sedation in dentistry is a useful audittopic in both primary and secondary care.

Preanalytical variables of biospecimens play a vital role in biobanking. Currently, there is a lack of a convenient and precise methods to document these variables. Paper documentation and computer-based Lab Information Management System software are the most common solutions, but both have clear disadvantages. An application named PancMoBio was newly developed in our pancreas biobank, with the guidance of good clinical practice principles as well as the incorporation of technical support from professional software companies. With portable electronic devices running this application, all data can be precisely collected in a synchronous manner during sample collection and processing. PancMoBio comprises two major modules-recording and searching-and five submodules in the recording module: blood sample collection, solid tumor tissue sample collection, cystic tumor sample collection, plasma sample separation, and serum sample separation. Compared with other methods, our application was found to be more convenient and accurate in recording preanalytical variables and demonstrated improved capability in facilitating real-time quality control and quality assurance. It was apparent that PancMoBio could improve the integrity of biospecimen and biobank quality management. Thus, it should be considered for further utilization in biobanking.

Aim: There is a lack of authorised medicines for paediatric patients and improved drug development is necessary. The aim of this study was to evaluate the need for infrastructure and support for paediatric clinical trials in Sweden. Methods: A web-based survey was sent to doctors and nurses involved in the care of neonates, children and adolescents assessing the current situation and future needs for paediatric clinical trials in Sweden. Questions regarding premises, competence, organisation, support for paediatric clinical trials and Good Clinical Practice Training were addressed. Results: In total, 137 individuals responded to the survey (109 doctors and 28 nurses). Overall, 61% of the respondents had previous experience of paediatric clinical trials. Some respondents had access to trial units, but only 34% had used the trial unit for support. Half of the responders were interested in recurrent paediatric Good Clinical Practice training. Doctors responded that clinical work often had to be prioritised and emphasised the need for research time. Conclusion: This study clearly shows the commitment for clinical trials among doctors and nurses involved in paediatric care in Sweden, but also that administrative, logistic and economic support in a sustainable setting and an expanded national collaboration are needed. (Less)

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials. Regulatory agencies conduct GCP inspections to verify the integrity of data generated in clinical trials and to assure the protection of human research subjects, in addition to ensuring that clinical trials are conducted according to the applicable regulations. The first joint GCP workshop of the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) and the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA-UK) was held in October 2018 and provided the agencies' perspectives on the importance of data quality management practices on data integrity. Regulatory perspectives on data blinding to minimize introduction of bias, and the role of audit trails in assessing data integrity in global clinical trials were discussed. This paper summarizes considerations of both agencies on these topics, along with case examples.

Sepsis accounts for 50% of intra-hospital mortality. Septic shock is diagnosed in 2% of patients with half of these needing for Intensive Care Unit (ICU) transfer. An algorithm was applied for mortality, need for intensive care transfer and length of stay decrease. The observational study was performed on 231 consecutive enrolled patients with sepsis or septic shock admitted to the University Campus Bio-Medico of Rome. The algorithm was based on good clinical practice application of antimicrobial stewardship. Data were compared with data from comparable population of National and European surveys. In the study group, the global mortality rate was 26.8% (3.9% was intra-hospital and 23% 90-d mortality), need of ICU transfer was registered in 21.6%, and the median length of stay was 15 days. Globally, intra-hospital and 90-day mortality, were significantly lower than at national level (26.8% vs 63.6%, P

History-taking and clinical examination was developed and advocated by Hippocrates to understand diseases and patients. Accurate history-taking plays a crucial role in the assessment of patients with cardiovascular disease and clinical examination follows history-taking. Both form a crucial part of good clinical practice in cardiology.

Clinical trial regulations ensure that the clinical studies are carried out in a transparent manner with focus on highest standards of safety. The regulatory system also provides guidance so that the trials are efficient while providing authentic and credible data on human exposure. This chapter discuss various aspects of regulations related to clinical trials in different regulated markets including approval process, good clinical practice guidelines, harmonization of clinical trial regulations, quality assurance in clinical trials, and ethical aspects including institutional review board, informed consent, pharmacovigilance, data privacy, safety of human subjects and duties and responsibilities of various stakeholders.

National audience; [No abstract available]

BACKGROUND: Difficult-to-treat-depression (DTD) is a clinical challenge. The interventions that are well-established for DTD are not suitable or effective for all the patients. Therefore, more treatment options are highly warranted. We formulated an evidence-based guideline concerning six interventions not well-established for DTD in Denmark.METHODS: Selected review questions were formulated according to the PICO principle with specific definitions of the patient population (P), the intervention (I), the comparison (C), and the outcomes of interest (O), and systematic literature searches were performed stepwise for each review question to identify relevant systematic reviews/meta-analyses, and randomized controlled trials. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was used to assess the methodological quality of the included studies. Clinical recommendations were formulated based on the evidence, the risk-benefit ratio, and perceived patient preferences.RESULTS: We found sufficient evidence for a weak recommendation of repetitive transcranial magnetic stimulation (rTMS) and cognitive behavioural analysis system of psychotherapy (CBASP). The use of bright light therapy in DTD was not sufficiently supported by the evidence, but should be considered as good clinical practice. The interventions should be considered in addition to ongoing antidepressant treatment. We did not find sufficient evidence to recommend intravenous ketamine/esketamine, rumination-focused psychotherapy, or cognitive remediation to patients with DTD.CONCLUSION: The evidence supported two of the six reviewed interventions, however it was generally weak which emphasizes the need for more good quality studies. This guideline does not cover all treatment options and should be regarded as a supplement to relevant DTD-guidelines.