The International Council for Harmonisation E6 (R3) revision and its impact on clinical research practice: A narrative review

British Journal of Clinical PharmacologyVolume 43, Issue 1 p. 3-7 Free Access Fraud and misconduct in medical research Frank Wells, Frank Wells 3 The Granaries, Tuddenham St Martin, Ipswich 1P6 9BW, UKSearch for more papers by this author Frank Wells, Frank Wells 3 The Granaries, Tuddenham St Martin, Ipswich 1P6 9BW, UKSearch for more papers by this author First published: 18 July 2008 https://doi.org/10.1111/j.1365-2125.1997.tb00129.xCitations: 1AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat References 1 Brock P. A pharmaceutical company's approach. In Fraud and Misconduct in Medical Research (ed SP Lock, FO Wells) 1996 London : BMJ Publishing Group. 2 Dyer O. GP struck off for fraud in drug trials. Br Med J 1996; 312: 643. 3 Swan N. Preventing and dealing with scientific fraud in Australia. Med J Aust 1989; 150: 169– 170. 4 Lock SP. Lessons from the Pearce affair: handling scientific fraud. Br Med J 1995; 310: 1547– 1548. 5 Association of the British Pharmaceutical Industry. Report on fraud and misconduct in clinical research. London : ABPI, 1992. 6 Royal College of Physicians of London. Report on fraud and misconduct in medical research. London : RCP, 1991. 7 Editorial. Dealing with deception. Lancet 1996; 347: 843. 8 Association of the British Pharmaceutical Industry. Guidelines for investigators on good clinical (research) practice. London : ABPI, 1996. 9 Association of the British Pharmaceutical Industry. Good Clinical Research Practice Guidelines. London : ABPI, 1988. 10 European Commission. Good Clinical Practice Guidelines. Brussels : EC, 1991. 11 International Conference on Harmonisation: Guidelines on Good Clinical Practices. Geneva : IFPMA, 1996. 12 Association of the British Pharmaceutical Industry. Statistical methods in the investigation of fraud. London : ABPI, 1993. 13 SP Lock, FO. Wells (eds). Fraud and Misconduct in Medical Research. London : BMJ Publishing Group, 1996. Citing Literature Volume43, Issue1January 1997Pages 3-7 ReferencesRelatedInformation

BackgroundThe International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has published the ICH E6(R2) Good Clinical Practice (GCP) guideline, which provides standards for the design, conduct, documentation, and reporting of clinical trials. Revision to E6(R2) is currently underway, aiming to adapt the guidance to the current regulatory environment. The Clinical Trials Transformation Initiative (CTTI) interviewed stakeholders, gathering their experiences implementing ICH E6 GCP and suggestions for revising the guidance. MethodsWe conducted a qualitative descriptive study using in-depth interviews. Participants were purposefully selected to ensure diversity in geography, research role, and type of institution. Participants reflected on their aspirations for the ICH E6 GCP revision and described sections of the guidance that they found most and least helpful. Narratives were analyzed using applied thematic analysis. ResultsMany participants found ICH E6 GCP generally clear and helpful. They appreciated that the guidance is globally accepted and serves as a common standard for research worldwide. Participants also noted opportunities for improvement, suggesting that the revised guidance should incorporate flexibility, simplify requirements, and accommodate advances in research conduct. They highlighted areas where language should be updated and concepts clarified and expressed a desire for transparency and inclusiveness in the revision process. ConclusionOur findings show that many participants view the ICH E6(R2) guidance as helpful overall, although substantial room for improvement remains. We have provided the full report of these findings to ICH in hopes that it will be useful as the E6 GCP guideline is revised.

Background:Clinical trials play an important role in the generation of evidence-based data in health care practices. To ensure the credibility of data and the safety and well-being of the patients Good clinical practice (GCP) guidelines play an important role. At present, we have little knowledge about awareness of GCP guidelines among health care providers in India.Aim:To assess the level of awareness, and perception of the health care providers toward GCP and subsequent change in these after a dayer training session on GCP guidelines.Settings and Design:A cross-sectional descriptive questionnaire-based study was conducted amongst health care providers, that is, doctors, dentists, nurses of a Tertiary Health Care and Teaching Institute.Materials and Methods:Participants were given descriptive questionnaire; they completed the questionnaire before and after undergoing a day training program in GCP guidelines.Statistical Analysis Used:The impact of the effectiveness of educational intervention among healthcare professionals was evaluated by two-tailed Z-test.Results:Out of 120 participants, 80 were medical doctors, 20 dental doctors, and 20 nurses. A dayse training program on GCP guidelines was found to increase positive attitudes toward various aspects of clinical trials.Conclusion:A day's training program on GCP guidelines may help to increase the knowledge as well as awareness about principles and techniques of clinical research, which will increase the credibility of clinical research in the country.

1349 Good clinical practice (GCP)

Current policies on informed consent in Japan constitute a formidable barrier to emergency research

Promoting good clinical practices in the conduct of clinical trials: experiences in the department of veterans affairs cooperative studies program

To the Editor: We wish to provide Journal readers with additional information on the article by Vesikari et al. (Oct. 13, 2011, issue),1 which states that the study was compliant with Good Clinical Practice (GCP) guidelines. Novartis Vaccines and Diagnostics included the data from this study in the marketing authorization dossier for Fluad pediatric influenza vaccine, which was submitted to the European Medicines Agency (EMA). A GCP inspection that was requested during the scientific assessment by the Committee for Medicinal Products for Human Use revealed a lack of compliance with GCP guidelines on several critical issues affecting the reliability of . . .

The new Good Clinical Practice (GCP) guidelines, which were based on ICH-GCP, were enforced in Japan in April 1997. These guidelines recommend that pharmacists play the role of managers of investigational drugs and also as cooperators (clinical research coordinator) in the performance of clinical trials. In this study, we carried out a survey of the attitude of the new graduate pharmacists (the group of graduates in the 1998 fiscal year and a group of graduates in the 1999 fiscal year) on clinical trials. After the first questionnaire, we lectured the students on GCP and performed clinical trials, and then the second questionnaire was conducted two months later. The group of graduates in the 1999 fiscal year had more opportunities to come in contact with information on clinical trials than the group in the 1998 fiscal year. Both groups knew that new GCP guidelines had been established, but they did not understand the details. Some of them had a negative impression concerning clinical trials. The lectures improved their knowledge and impression on the practice of clinical trials. After the lecture, over 90% of them thought that pharmacists should manage investigational drugs and provide information on these drugs for the rational practice of clinical trials. Furthermore, in 60% or more of the students, an improvement in the consciousness of evaluating the safety and efficacy of investigational drugs regarding the pharmacist's role was found.

In the rapidly evolving field of clinical research, the effective management of data is paramount. A robust data management framework is essential for ensuring the integrity, security, and accessibility of data throughout the research lifecycle. This framework not only supports compliance with regulatory requirements but also enhances the efficiency and reliability of research outcomes. Developing a data management framework for a clinical research institution involves a comprehensive approach that integrates best practices in data collection, storage, processing, and analysis. It requires a thorough understanding of the unique challenges and needs of clinical research, including the handling of sensitive patient information, adherence to ethical standards, and the facilitation of collaborative research efforts. This framework introduces sets the stage for exploring the key components and strategies involved in creating an effective data management framework, highlighting its critical role in advancing clinical research and improving quality of research data throughout comprehensive data management processes. This is the result of a long-journey of studying the SCDM’s Good Clinical Data Management Practices (GCDMP©) (SCDM, 2013), ICH E6 (R2) Good clinical practice (ICH) and practical experiences of Data Managers of the Oxford University Clinical Research Unit.

Introduction. In the context of digital transformation and global harmonization of regulatory requirements, the implementation of integrated quality management systems in clinical trials based on ICH E6(R3) has become increasingly relevant. Aim. To conduct a comparative analysis of ICH E6(R3) against international standards (ISO, GAMP 5, PMBOK/APM-BOK) and assess their adaptability within the Russian regulatory environment. Materials and methods. A systematic analysis was performed of the Russian regulatory framework – including Federal Law No. 61-FZ of April 12, 2010; Decision No. 79 of the Eurasian Economic Commission Council of November 3, 2016, approving the Good Clinical Practice Rules of the Eurasian Economic Union; and GOST R 52379-2005 "Good Clinical Practice" – as well as international guidelines (ICH, ISO, PMI, ISPE) and scientific publications from 2020 to 2025 indexed in Scopus and Web of Science. Results and discussion. It was established that ICH E6(R3) necessitates a shift from reactive oversight to proactive quality management through the integration of risk-based approaches, digital technologies, and interdisciplinary standards. Within the Russian context, gaps in regulatory provisions and insufficient integration of quality management systems were identified. Conclusion. To align with ICH E6(R3), Russian regulatory authorities and organizations must modernize internal processes, implement Risk-Based Quality Management (RBQM), and harmonize national requirements with international standards.

Clinical research is a mechanism or a process that provides concrete evidence that new treatments or remedies suggested are safe and effective. The ultimate aim of clinical research is the identification and discovery of contemporary diagnostic methods as well as the establishment of advanced standards of therapy. Good clinical practice (GCP) is an ethical and scientific quality standard for designing, conducting and recording trials that involve the participation of human subjects. Acquiescence with the guideline gives a pledge to the public that the morality, integrity and welfare of humans participating in the trials are protected. India offers distinctive opportunities for performing clinical trials with large patient population, experienced and well-equipped investigators and leading medical institutions with low patient trial cost when compared to the regulated nations. However, to ensure a uniform standard of clinical research in the entire nation and to provide data for registration for new drugs before use in human population in India, there was a need for our own Indian Guidelines. GCP guidelines were developed by an accomplished committee set up by CDSCO along with the clinical experts. This article elucidates the significance of Good Clinical Practice from an Indian Clinical Research perspective, whilst defining and outlining the goals and objectives of GCP. It addresses the historical events that led to the emergence of Good Clinical Practices and examines the current scenario with regards to the application of GCP in Clinical trials in India. Finally, the article analyses the challenges faced with regards to maintaining an evidential and competitive system and also suggest a way forward for further enhancing the credibility and efficiency of Good Clinical Practice in Clinical Research.

High-quality human studies are indispensable to obtain credible scientific evidence for nutritional effects on the structure and functioning of the human body in health and disease. Although nutrition studies can have specific characteristics in terms of populations, outcomes, designs, methodologies and interventions,1 it is clear that human nutrition research should follow the established basic scientific and operational principles for high-quality design and execution of human studies. These aspects, together with those related to subject protection, form the basis of the ICH Good Clinical Practice (GCP) guidelines.2 Consequently, the GCP principles are relevant and important for human nutrition research. In fact, nearly all articles of the GCP guidelines can be applied to nutrition studies. However, some GCP aspects need a certain level of adaptation to be practically incorporated into nutrition trials. These are discussed in the current paper.

During a three-week long practical training program for pharmacy students at our hospital, senior pharmacy students had a one-day observation of pharmacists performing new drug investigations. Using a questionnaire survey we investigated whether the observation of the work of clinical research coordinator (CRC) influenced the student's understanding of the new drug investigation procedures. The observation of CRC's work consisted of counseling/interviewing prior to the doctor's consultation and visiting a clinical laboratory to observe new drug investigations. The items evaluated were impressions of the clinical investigation of new drugs, precautions for preparing investigational drugs, understanding the new Good Clinical Practice (GCP) guidelines and other important aspects in the clinical investigation. Each group consisted of 26 students. Only 10 out of 26 students observed counseling/interviewing before the doctor's consultation with CRC. The impression of the clinical investigation procedure in group I, which observed the CRC's work was more favorable than in group II, which did not observe it. The understanding of the important aspects of the clinical investigation procedures in group I was markedly better than in group II. We thus consider that the observation of the CRC work is very useful for students not only to learn new drug investigation procedures, but also to understand the meaning of the new GCP guidelines.

Trial participants' rights after authorisation of COVID-19 vaccines

International Good Clinical Practices Guidelines (GCPG) for Antithrombotics in CANCER Patients