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To implement the regional guidelines on the management of diabetic foot (DF) into real practice, the diabetiologists working in the public diabetologic services of the Tuscany Region Health Service launched an bottom-up initiative called Diabetic Foot Valley, aiming in creating a community of practice for DF care in Tuscany, Italy. The project, started in 2022 with three meetings dedicated to acute, sub-acute and chronic DF, respectively. The outcomes were articulated into amelioration projects (APs) which targeted the critical issues identified by the analysis performed inside the three meetings and which will be carried on in 2023 and 2024. The outcomes of the APs will be evaluated at the end of their development and compared to the baseline, to evaluate the progress made. The APs already in place are those related to revascularisation, surgical management, local care and networking, with the designing and building of a dedicated electronic platform; others, like those dedicated to offloading, screening and prevention, rehabilitation and follow-up will start in 2024. The project, endorsed by Regione Toscana and European Wound Management Association (EWMA), will serve as a pilot which can be a point of referral for similar experiences in other European countries for the implementation of the international guidelines on DF. [ABSTRACT FROM AUTHOR]

Background: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is undertaking a major revision of ICH E6 Good Clinical Practice (GCP) decided to involve external stakeholders in ICH-GCP renovation. Activities such as surveys and public conferences have taken place in the United States, European Union, and Japan. For stakeholder engagement in Japan, a designated research group conducted a survey of academic stakeholders. Methods: A total of 105 academic stakeholders from 18 institutions responded to the survey. The research group developed recommendations reflecting the survey results and the opinions from patients and the public. Results: The survey showed the top four principles needing renovation were (i) informed consent (Chapter 2.9, 12.4% of respondents believed it needed renovation), (ii) systems for quality assurance (Chapter 2.13, 9.5%), (iii) information on an investigational product (Chapter 2.4, 5.7%), and (iv) procedures on clinical trial information (Chapter 2.10, 5.7%). The top three sections identified as needing renovation were: (i) informed consent (Chapter 4.8, 27.6%), (ii) monitoring (Chapter 5.18, 22.9%), and (iii) composition, functions, and operations of the ethics committee (Chapter 3.2, 14.3%). Recommendations included clarification of ICH-GCP's scope, proportionality in various aspects of clinical trials, diversity and liquidity of ethics committee members, modernization of informed consent procedures, variations in monitoring, and regulatory grade when using real-world data. Conclusion: The recommendations from Japanese investigators and patients have been submitted to the ICH E6 Expert Working Group, which will strengthen the robustness of the GCP renovation. [ABSTRACT FROM AUTHOR]

This article aims to provide a comprehensive overview of the educational pathways and responsibilities of research nurses in Europe, particularly focusing on their essential role in conducting research in clinical settings, including clinical trials, while adhering to ethical and regulatory standards. Research nurses play a crucial role in clinical research settings, especially in clinical trials, ensuring adherence to ethical and regulatory standards. Understanding their educational pathways and responsibilities is essential for promoting consistency and quality in research practices across Europe. Between October and November 2022, relevant European nursing education authorities, including those focused on research nursing, were contacted to participate in an online cross-sectional survey. The survey aimed to gather information about research nurse education and training in their respective countries. The study followed a cross-sectional design. Contacts were made with European nursing education authorities based on recommendations from the VACCELERATE National Coordinators and the VACCELERATE Site Network. Participating organizations were invited to complete an online survey regarding research nurse education in their countries. Responses were obtained from 37 European countries, a response rate of 74%. The most common terms used to refer to nurses involved in clinical trials and epidemiological studies were "study nurse" (62%) and "clinical research nurse" and "research nurse" (43% each). The requirements to become a research nurse varied across countries, with a nursing degree necessary in 87% of countries and Good Clinical Practice (GCP) courses mandatory in 81%. Local providers of research nurse courses existed in 84% of countries, coordinated by online organisations (51%) or universities/hospitals (46%). The most common tasks assigned to research nurses were the administration of investigational medicinal products (from 78% in observational studies to 89% in phase IV trials) and blood sample processing (84% in phase II and IV trials). This study provides valuable insights into research nurse education and tasks in European countries. It highlights the need for standardisation to enhance consistency and quality of training across Europe. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

The United Kingdom's (UK's) imminent departure from the European Union (EU) has a further but usually overlooked consequence: The UK will also be leaving the various global fora where it has been represented with other Member States of the EU. In many cases, the UK will still have to comply with the global regulatory tools, including norms and standards, made by these fora. The UK's departure from the EU thus raises the more general question of how those formally outside the fora that set global norms and standards can navigate membership procedures in order to become involved in setting them. This article focuses on the example of the International Council on Harmonisation (ICH) and its work in harmonizing good clinical practice (GCP) in relation to clinical trials for pharmaceuticals. By reference to this example, the article underlines the importance of the ICH to global standard-setting for GCP and the importance of engagement in this forum by those that do not have a formal role in setting the standards, but that must abide by them nonetheless if they are to trade globally. Subsequently, the article explains the formal procedures for membership and involvement in standard-setting. In doing so, the article aims to provide a roadmap towards membership and a say in global standard-setting. [ABSTRACT FROM AUTHOR]

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 most 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. [ABSTRACT FROM AUTHOR]

Background: The DIA’s Good Clinical Practice and Quality Assurance Community (DIA GCP/QA) created a working group to develop templates for a protocol deviation standard operating procedure (SOP) and protocol deviation handling plan (PDHP). Methods: The working group consisted of QA auditors, data managers, statisticians, and clinical monitors from several pharmaceutical companies, academia, and independent auditing firms. Various examples of standard operating procedures, data handling plans, and auditing plans were examined, and the core elements extracted into the initial PD SOP and PDHP templates. The draft templates were presented at a workshop at the DIA 51st Annual Meeting held in June 2015 in Washington, DC, and feedback was incorporated. The workshop came at the heels of a previously published position paper, “The Lifecycle and Management of Protocol Deviations.” Results: The PD SOP and the PDHP templates are presented in this article. They are a starting point, and each company will need to modify to suit its individual needs. Conclusions: This article expands on the position paper to include concrete tools for the management of protocol deviations, including best practices for detection, classification, mitigation, and management of protocol deviations with a goal to reduce the impact on subject safety and data integrity. [ABSTRACT FROM AUTHOR]

Good Clinical Practice (GCP) is an international standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. The goal of GCP is to ensure the protection of the rights, integrity, and confidentiality of clinical trial participants and to ensure the credibility and accuracy of data and reported results. In the United States, trial sponsors generally require investigators to complete GCP training prior to participating in each clinical trial to foster GCP and as a method to meet regulatory expectations (ie, sponsor’s responsibility to select qualified investigators per 21 CFR 312.50 and 312.53(a) for drugs and biologics and 21 CFR 812.40 and 812.43(a) for medical devices). This training requirement is often extended to investigative site staff, as deemed relevant by the sponsor, institution, or investigator. Those who participate in multiple clinical trials are often required by sponsors to complete repeated GCP training, which is unnecessarily burdensome. The Clinical Trials Transformation Initiative convened a multidisciplinary project team involving partners from academia, industry, other researchers and research staff, and government to develop recommendations for streamlining current GCP training practices. Recommendations drafted by the project team, including the minimum key training elements, frequency, format, and evidence of training completion, were presented to a broad group of experts to foster discussion of the current issues and to seek consensus on proposed solutions. [ABSTRACT FROM AUTHOR]

Background: Data quality issues in clinical trials can be caused by a variety of behaviors including fraud, misconduct, intentional or unintentional noncompliance, and significant carelessness. Regardless of how these behaviors are defined, they may compromise the validity of the study results. Reliable study results and quality data are needed to evaluate products for marketing approval and for decisions that are made on the use of medicine. This article focuses on detecting data quality issues, irrespective of origin or motive. Early detection of data quality issues are important so that corrective actions taken can be implemented during the conduct of the trial, recurrence can be prevented, and data quality can be preserved. Methods: A survey was distributed to TransCelerate member companies to assess current strategies for detecting and mitigating risks involving fraud and misconduct in clinical trials. A review of literature across many industries from 1985 to 2014 was conducted using multiple platforms. Results: Eighteen TransCelerate member companies anonymously responded to the survey. All of the respondents had one or more existing strategies for fraud and misconduct detection. The literature search identified current practices and methodologies across many industries. Conclusions: TransCelerate recommends the creation of an integrated, multifaceted approach to proactively detect data quality issues. Detection methods should include a strategy tailored to the characteristics of the study. Some sponsors are taking advantage of more advanced methods and integrated processes and systems to proactively detect and address issues, relying on advances in technology to more efficiently review data in real time. Further research is underway to assess statistical data quality detection methodology in clinical trials. [ABSTRACT FROM AUTHOR]

The article provides a summary of the background and past activities of the E6 Discussion Group established under the International Pharmaceutical Regulators Forum. Topics discusses include the establishment of the Regulators Forum to create a regulator-only environment, the development of a statement on general principles for the training and education of Good Clinical Practice (GCP) inspectors which will serve as a reference to regulatory agencies.

The article discusses a study on having a common definition for protocol deviations in clinical trials, documenting its life cycle and best practices to manage, detect and classify them. Topics covered include the protocol deviations handling plan (PDHP), Corrective Action Preventive Action (CAPA) programs and the clinical study report (CSR) data. Conclusions include recommendations for minimizing protocol deviations including well-reviewed clinical trial protocols with standard terminology.

The article presents a study which aims to identify the legal definitions and requirements for non-interventional drug studies (NIS). It states that the involved respondents were asked to answer questions related to the effect of international recommendations, the industry self-regulation standards, and the existence of data privacy. The result of the survey show that the respondents confirmed that planned legislation on NIS subsist in almost half of all countries dealt by the survey.

The article focuses on a risk-based quality initiative, Pharmaceutical Quality for the 21st Century, launched by the U.S. Food and Drug Administration (FDA), which relies on quality by design (QbD). The initiative offers oversight of critical parameters and product quality to drug manufacturers. Applying the QbD approach to clinical research would reportedly ensure that a quality management has been developed alongside the protocol and before trial initiation.

The article discusses the complex legal and practical challenges faced by the U.S. academic institutions and industry relating to implementation of clinical trials abroad. Information on the U.S. Health Insurance Portability and Accountability Act of 1996, Good clinical practices, and Export control laws is presented. It suggests that preparations should be specific to the nature of clinical trial, the population participating in a trial, and the country in which the trial takes place.

Summary: Tuberculosis (TB) drug development has made substantial progress in the past decade. There are currently at least ten drugs being evaluated in clinical trials. Some belong to chemical classes already employed in first- or second-line treatment regimens and are being explored for more optimized use at higher doses or in new drug combinations (rifamycins, fluoroquinolones and oxazolidinones), while others represent potential novel members of the TB drug arsenal, killing Mycobacterium tuberculosis through previously untried mechanisms of action (nitroimidazoles, diarylquinolines, ethylene diamines and pyrroles). The typical challenges of drug development are augmented in TB by the complexity of the disease, the requirement for multi-drug regimens, the relative lack of TB drug development for the past several decades, and inadequate resources being brought to bear despite the urgency of the global medical need. Yet in the face of these challenges, for the first time in history, there is a robust enough pipeline of drugs in development to potentially enable identification of a novel, three-drug regimen capable of curing patients in three months or less, whether they are infected with a strain of M. tuberculosis sensitive or resistant to the current first and second-line drugs. Realizing this potential will require innovation, persistence, cooperation and resources. A fine balance will need to be achieved between protecting novel drugs so that resistance to them doesn’t develop and ensuring the regimens are low in cost, readily available, and adopted by healthcare systems and providers. [Copyright &y& Elsevier]

Human subjects protection policies developed for pharmaceutical trials are now being widely applied to psychosocial intervention studies. This study examined occurrences of serious adverse events (SAEs) reported in multicenter psychosocial trials of the National Institute On Drug Abuse Clinical Trials Network. Substance-abusing participants (N = 1,687) were randomized to standard care or standard care plus either contingency management or motivational enhancement. Twelve percent of participants experienced I or more SAEs during the 27,198 person-weeks of follow-up. Of the 260 SAEs recorded, none were judged by the data safety monitoring board to be study related, and there were no significant differences between experimental and control conditions in SAE incidence rates. These data underscore the need to reconsider the rationale behind, and appropriate methods for, monitoring safety during psychosocial therapy trials. [ABSTRACT FROM AUTHOR]

The European Directive on clinical trials of medicinal products will fall within the scope of the legislation of Member States on 1 May 2004. In France, this adaptation will be carried out by a public health bill concerning, among other things, the reform of the current Huriet-Sérusclat law, and by means of regulations. For trials concerning the initial administration of a product to human subjects, the group suggested the following recommendations: • In French texts, to include a deadline of 30 days for the initial authorisation by the competent authority (Afssaps [Agence française de sécurité sanitaire des produits de santé]). • To maintain an observed deadline of 20 days (35 official days) for the decision of the Ethics Committee (EC) [Committee for the Protection of Persons (CPP)]. • To obtain a more specific evaluation of the pharmaceutical dossier of the investigational medicinal product (IMP) from the competent authority. • To provide both bodies with nonclinical and possibly clinical data concerning the IMP information of the participants and their consent. • To follow the recommendations posted on the Afssaps website for the entire IMP dossier. • To submit a protocol under the International Committee on Harmonisation (ICH) E6 format adapted for phase I and, possibly as a separate document, justification of a certain number of points (a total of ten) that are more specific to this trial phase to facilitate and improve the document review while also providing the expected guarantees. • To limit the ‘substantial’ amendments to those provided for in the European guidelines. • To break the blind for every serious event reported to the sponsor by the investigator, and report to the competent authority any serious adverse event related to the IMP or to the trial or without documented cause, while keeping ECs and investigators informed. Furthermore, certain points concerning the authorisations for packaging, labelling and dispensing of the batches of medicinal products for clinical trials will need to be specified for these early studies. All these recommendations are intended to help promote the development of studies involving the initial administration of medicinal products in France. Keywords: clinical trial directive, phase I, transposition, drug, legal frame, good clinical practice [ABSTRACT FROM AUTHOR]

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Abstract: Translational clinical research has emerged as an important priority for the national research enterprise, with a clearly stated mandate to more quickly deliver prevention strategies, treatments and cures based on scientific innovations to the public. Within this national effort, a lack of consensus persists concerning the need for clinical nurses with expertise and specialized training in study implementation and the delivery of care to research participants. This paper reviews efforts to define and document the role of practicing nurses in implementing studies and coordinating clinical research in a variety of clinical settings, and differentiates this clinical role from the role of nurses as scientists and principal investigators. We propose an agenda for building evidence that having nurses provide and coordinate study treatments and procedures can potentially improve research efficiency, participant safety, and the quality of research data. We also provide recommendations for the development of the emerging specialty of clinical research nursing. [Copyright &y& Elsevier]