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June 2020 | Newsletter # 30 1
WWW.CIOMS.CH June 2020 | Newsletter # 30
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1 COVID-19: CIOMS Working Group XII Statement
3 Update on CIOMS Working Groups | Just published: Consensus report of the CIOMS Working Group on Drug-Induced Liver Injury
4 Conference news CIOMS at DIA | Conference announcement
5 Publications roundup: New books | COVID-related publications and guidelines
7 News from the CIOMS Secretariat: 87th CIOMS Executive Committee meeting In memory of Professor Folke Sjöqvist
C VID-19
Medicines assessment during public health emergencies needs good science, best practices and proper communication
Statement1 of a CIOMS International Expert Working Group*
*CIOMS Working Group WG XII: Benefit-Risk Balance for Medicinal Products – Update of CIOMS IV
Working Group webpage List of members
Following the essential principles of evidence-based medicine and regulatory decision-making remains key also in times of public health emergencies. As has been the case with the COVID-19 pandemic, such emergencies can develop rapidly, and much-needed, robust, scientific data may not be immediately available to close the knowledge gaps. Pressures to make decisions without proper evidence have the potential to overcome sound scientific judgement and lead to unjustifiable conclusions, as well as the use of unproven therapies that may be ineffective or harmful, and have a further negative impact on public health.
Continued /
1 Disclaimer. The views and opinions expressed in the statement above are consolidated views of the participants of the CIOMS Working
Group and should not be attributed to any individual expert in those or any organization with which these individuals are employed or affiliated.
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/ Continued
One of the most complex, scientific activities during public health emergencies is to determine whether a candidate medicine intended to prevent or treat the disease is effective, and establish whether its expected benefits outweigh its potential risks to patients. This assessment is based on all available evidence about the medication and the surrounding situation including: the severity of the disease; how well patients’ medical needs are addressed by alternative, available therapies; the uncertainty around how data from clinical trials or testing environments extrapolate to real-life situations; and whether specific risk management measures need to be applied to mitigate known and/or potential risks. In the case of a public health emergency, such information is often not readily available in sufficient quantity or quality to adequately support evidence-based decision-making, and the urgency of the decision context magnifies the potential consequences of action or inaction.
When decision-making in the face of high uncertainty cannot be avoided, increased focus on monitoring the safety and effectiveness of such new therapies once they are approved for use in the public domain is critical. Considerations for this expanded surveillance role should include appropriate, evidence-generating or adverse reaction monitoring strategies such as: phase IV clinical trial studies; observational studies; manufacturer-run patient registries and/or patient support programmes; patient focus groups and implementing proactive adverse reaction monitoring strategies. The monitoring of “repurposed” medicines will also be necessary under the different uses made in the pandemic, since their efficacy/effectiveness remain to be confirmed and their safety profile may well be different in a different indication. In addition, the acceptability of potential harms may be different than in other indications.
The contemporary pharmaceutical development systems benefit from the collaborative efforts of multiple stakeholders including regulators, industry, academia, patients, health-care providers and health insurers, all of whom contribute to increasing knowledge about benefit/risk relationships and the consideration of the uncertainties. When facing a public health crisis, we urge all concerned parties to maintain solid, scientific, and evidence-based principles and best practices for conducting the proper benefit/risk assessment of potential new prevention or therapy options. Among others, potential confounders and possible bias should be considered when assessing available data. All parties should uphold full transparency of the decision-making process, with a high degree of focus on the relevance of the therapy decision for the patients being treated during the emergency.
In the midst of an emergent health crisis, stakeholders should follow best practices for communication and provide information that is timely, accurate, credible, understandable, actionable, consistent, and empathetic. Poor communication, such as a lack of information; unexplained changes in key messages; or failure to communicate uncertainties can undermine credibility and disrupt risk mitigation efforts.
Members of the various CIOMS Working Groups are working to define and advance measures and approaches to improve the development and benefit/risk assessment of new therapies and enhance public health. We wish to applaud the efforts of the health-care and scientific communities, including practitioners, regulators and patients, who have come together to fight COVID-19 and hope that the CIOMS Working Groups’ outcomes can also be helpful in addressing the product-related challenges and future decision-making during public health emergencies.
CIOMS Working Group XII, 3 June 2020
More about the Working Group and the List of its members is available here.
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Breaking news:
CIOMS congratulates Emer Cooke, Director of the WHO Regulation and Prequalification Department, on her nomination for the position of Executive Director of the European Medicines Agency (EMA). At the 2019 Open Meeting of the CIOMS WG on Patient Involvement Emer spoke to the importance of Patient centricity in regulatory work.
Right: Emer Cooke, presenting the WHO viewpoint at the CIOMS Open Meeting on Patient Involvement
Update on CIOMS Working Groups
1 New Working Group (WG) launched
>180 Members in six active Working Groups*
2 New publications**
*Active CIOMS Working Groups (Participants are listed in the meeting minutes on the CIOMS website):
Clinical Research in Resource-Limited Settings Working Group (webpage)
Drug-Induced Liver Injury (webpage) – Consensus report published 16 June 2020, see below
MedDRA Labelling Groupings (webpage)
Working Group XI on Patient involvement in development and safe use of medicines (webpage) (and see end of page)
Working Group XII on Benefit-risk balance for medicinal products (webpage)
NEW: Working Group XIII on Real-world data and real-world evidence in regulatory decision-making
(webpage )
**New CIOMS publications:
Medicines assessment during public health emergencies needs good science, best practices and proper
communication. Statement of CIOMS Working Group WG XII: Benefit-Risk
Balance for Medicinal Products Reproduced in full on pp 1-2
Drug-induced liver injury (DILI): Current status and future directions for drug development and the post-market
setting. A consensus by a CIOMS Working Group. Geneva, Switzerland: Council for International Organizations of
Medical Sciences (CIOMS), 2020. 1195 views, 484 downloads (as of 24 June 2020)
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Conference news
CIOMS at the DIA 2020 Global Annual Meeting
Virtual conference, 12-18 May 2020
Report of CIOMS Working Group on Drug-Induced Liver Injury (DILI)
Session 17 June 2020, 11:30 am-12:30 pm The CIOMS DILI Working Group has finalized its consensus report, which presents best practices in DILI risk assessment, management and biomarker development in clinical trials and the post-market setting. Working Group members Mark Avigan (session chair), Hervé Le Louët, Arie Regev, Robert Fontana and Walter Straus presented the recom-mendations of this CIOMS report.
Drug-induced liver injury (DILI) is a growing challenge because of the ever-increasing number of drugs used in medical care. With new technologies and approaches being explored to prevent, detect, diagnose and manage DILI, this much-awaited consensus report fills a need for standard guidelines for pharmaceutical industry, regulators, scientists and health professionals.
Speakers: CIOMS WG members Walter Straus, Hervé le Louët, Arie Regev, Mark I Avigan (session chair) and Robert J Fontana
MedDRA® Labeling Groupings for Enhanced
Communication of Safety Concepts: Cinderella’s Glass Slipper?
On-demand session The CIOMS Working Group on MedDRA Labeling Groupings (MLG) is developing principles to facilitate global convergence of various indepen-dent safety communication initiatives.
Speakers: CIOMS Working Group members William Gregory, Sonja Brajovic, Ilona Grosse-Michaelis and Scott Proestel.
CIOMS at DIA Europe 2020
Virtual conference, 30 June-3 July 2020
Patient Involvement in the Development and Safe Use of Medicines
Session 30 June 2020, 11:00-12:00
Speakers: CIOMS Secretary-General Lembit Rägo, CIOMS Working Group XI member François Houÿez, Patrick Brown (University of Amsterdam) and Florence Hunsel (Pharmacovigilance Centre Lareb, Netherlands).
The next face-to-face DIA Europe will take place on 17–19 March 2021 in Basel, Switzerland.
Conference announcement
Porto, Portugal, 8-11 March 2021
To be held under the auspices of: World Medical Association (WMA)* International Federation of Medical Students
Associations (IFMSA)* World Federation for Medical Education
(WFME) CPME – Comité Permanent des Médecins
Européens – Standing Committee of European Doctors
Association for Medical Education in Europe (AMEE).
* CIOMS member The immediate past President of CIOMS, Johannes JM van Delden, is planning to attend.
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Publications roundup Communicating about safe use of medicines: Real life and applied
research This new book brings together, for the first time, methodological overviews and advice from multiple disciplines for studying communication about medicines. It lays the ground for research into the causal relationships between structures, pro-cesses and outcomes of communication as well as impacting factors. Evidence from such research has the potential to improve communication among the many parties involved in ensuring patient safety and informed choices. The book includes methods
chapters on cognitive and behavioural sciences, rhetoric, social sciences, media sciences, design science, dissemination & implementation science and pharmacoepidemiology, as well as chapters on ethical and legal considerations. These are underpinned by illustrative examples and by four case study chapters giving insights into the challenges of communicating in practice and studying communication events. The opening chapter, authored by Priya Bahri, makes the case for establishing an inclusive discipline of humanities and epidemiology of medicinal product risk communication, while a call for an especially active role of patients is made in the concluding chapter by François Houÿez, member of CIOMS Working Group XI on Patient Involvement.
Written by experts with experience in the local and/or international arena also including CIOMS Working Group members Meredith Smith and Bert Leufkens, this book is of interest for all those involved in communicating about risks and safe use of medicines: researchers, medicines safety specia-lists, policy-makers, healthcare professionals, and last but not least, patient advocates.
The book is available from Springer Nature.
Ethical Research
The Declaration of Helsinki, and the Past, Present, and
Future of Human Experimentation
This book offers an inter-disciplinary approach to the field of research ethics. It pro-vides access to previously un-published sources related to the Declaration of Helsinki, and presents global and comparative perspectives on research conducted on human beings. The book can be pre-ordered from Oxford University Press here.
ICMR COVID-19 guidelines The Indian Council of Medical Research (ICMR) has issued its National Guidelines for Ethics Committees Reviewing Bio-medical & Health Research During COVID-19 Pandemic. The document is based on the 2017 ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, particularly the section titled Research during humanitarian emergen-cies and disasters, and provides additional new guidance points that are relevant to the COVID-19 situation.
These and other ICMR guide-lines can be downloaded here.
The editor of this new book, Priya Bahri, is a member of the former CIOMS Working Group on Vaccines Safety and editor of the CIOMS Guide to Vaccine Safety Communication.
The ICMR guidelines were compiled and edited by Dr Roli Mathur, Head of the ICMR Bioethics Unit. Roli is a member of the CIOMS Working Group on Clinical Research in Resource-Limited Settings and of the CIOMS Executive Committee.
This book was co-edited by CIOMS Executive Commit-tee member Dominique Sprumont. Contributors also include past CIOMS Secretaries-General Johannes van Delden and Juhana Idänpään-Heikkilä (†), as well as CIOMS former or present Working Group members Ruth Macklin, Dirceu Greco and Ames Dhai.
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COVID-19 and …
… Ethics
WHO Working Group on Ethics & COVID-19. Ethical standards for research during public health emergencies Distilling existing guidance to support COVID-19 R&D. Policy brief. WHO/RFH/20.1. 2020. (WHO publication)
WHO Working Group for Guidance on Human Challenge Studies in COVID-19. Key criteria for the ethical acceptability of COVID-19 human challenge studies. 6 May 2020. (WHO publication)
WHO. Ethical considerations to guide the use of digital proximity tracking technologies for COVID-19 contact tracing. Interim guidance, 28 May 2020. (WHO publication)
WHO. Guidance for research ethics committees for rapid review of research during public health emergencies. (WHO publication)
WHO. Ethics and COVID-19: resource allocation and priority-setting. Policy brief (living document). WHO-RFH-20.2. 2020. (PDF, accessed 19 June 2020)
Gostin LO, Friedman EA, Wetter SA. Responding to Covid-19: How to Navigate a Public Health Emergency Legally and Ethically. Hastings Cent Rep. 2020;50(2):8‐12. (Journal full text)
Emanuel EJ, Persad G, Upshur R, et al. Fair Allocation of Scarce Medical Resources in the Time of Covid-19. N Engl J Med. 2020; 382 (21): 2049–55. (Journal full
text)
… Research and development (R&D)
WHO R&D Blueprint and COVID-19. (Webpage) Updated information on global research activities, candidate vaccines and therapeutics, ethical guidelines and social aspects.
Graduate Institute Geneva. Knowledge portal on innovation and access to medicines. (Website)
COVID-NMA project. Living mapping and living systematic review of COVID-19 studies. (Webpage)
… Clinical research in resource-limited settings
COVID-19 Clinical Research Coalition. Electronic address: [email protected]. Global coalition to accelerate COVID-19 clinical research in resource-limited settings. Lancet. 2020;395(10233):1322‐1325. (Journal full text, PMC full text)
… Regulatory review
International Coalition of Medicines Regulatory Authori-ties (ICMRA). News. Statements and press releases. (Webpage)
African Vaccine Regulatory Forum (AVAREF). AVAREF GUIDELINES - Tools for Processing Clinical Trial Applications by Ethics Committees and National Regulatory Authorities in Africa. (WHO publication)
Indian Council of Medical Research (ICMR). COVID-19 guidelines for ethics committees and institutional review boards. (PDF) See also page 5.
… Testing
WHO. Coronavirus disease (COVID-19) Pandemic – Emergency Use Listing Procedure (EUL) open for in vitro diagnostics. (Webpage) Listings of diagnostics eligible for procurement with UN funds, and those authorized for use in jurisdictions of the International Medical Device Regulators Forum (IMDRF)
… Risk management and communication
WHO. EPI-WIN updates. (Webpage) Examples of topics: outbreak management, trans-mission, risk communication, protecting the vulnerable
… Medicines safety
WHO. Medicines Safety (Webpage). Includes safety updates on COVID-19 treatments.
… Drug-induced liver injury
Olry A, Meunier L, Délire B, Larrey D, Horsmans Y, Le Louët H. Drug-Induced Liver Injury and COVID-19 Infection: The Rules Remain the Same [published online ahead of print, 2020 Jun 8]. Drug Saf. 2020;1-3. (PMC free access, Journal full text)
COVID-19 and WHO
At the Seventy-third World Health Assembly held on 18–19 May 2020— the first-ever to be held virtually— the delegates from WHO Member States adopted Resolution WHA73.1 by consensus, expressing their commitment to a global COVID-19 response.
Images on this page by Miroslava Chrienova and Gordon Johnson from Pixabay
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News from the CIOMS Secretariat
87th meeting of the CIOMS Executive Committee
7 May 2020 (virtual meeting)
Like many other recent events, the meeting of the CIOMS Executive Council revolved mostly around the topic of the COVID-19 pandemic.
All organizations have had to adopt new ways of working. The CIOMS Working Groups have conti-nued to function on virtual platforms (see page 3). Encouragingly, participation in video calls has been higher than used to be the case with face-to-face meetings. On the other hand, in-person meetings remain irreplaceable for new groups to build rela-tionships of trust among their members, and for consensus-building within groups.
The new SARS-CoV-2 virus will continue to impact most aspects of society in years to come until an effective vaccine becomes widely available. Frustra-tingly little is known about this complex and poten-tially fatal disease. The mission of CIOMS—to advance public health through guidance on health research including ethics, medical product develop-ment and safety—as well as its nature of an inter-sectoral platform for technical discussion and consensus-building, remain highly relevant at the present time.
Participants (from top, left to right): Hervé Le Louët, Samia Hurst, Stella Blackburn, Gustavo Kesselring; Otmar Kloiber, Roli Mathur, Mongezi Mdhluli, Caroline Samer; Christine Wieland, Roberto Verna, Lembit Rägo and Ulf Bergman. Apologies: JJM van Delden, Michel Vallotton, Dominique Sprumont and Sev Fluss.
In memory of Professor Folke Sjöqvist
CIOMS is saddened by the loss of Professor Folke Sjöqvist, who passed away peacefully on 30 March 2020 at the age of 86 years after a long illness.
Appointed as Scandinavia’s first professor of clinical pharmacology in Linköping in 1970, Folke Sjöqvist was professor and clinical direc-tor at Huddinge Hospital from 1972 until his retirement. With over 300 peer-reviewed papers cited more than 16 000 times, he contributed some ground-breaking discoveries on the drug effects in patients and populations and had a major influence on the development of clinical pharmacology around the world. Professor Sjöqvist was a long-standing member of Karolinska Institutet’s boards and the Nobel Assembly, and received several doctorates, awards and prizes. However, his passion was in establishing clinical pharmacology as a scientific discipline, a teaching subject and a medical specialty not only in Sweden, but also in Europe and beyond.
For many years Professor Sjöqvist was a leader and source of inspiration within the International Union of Basic and Clinical Pharmacology (IUPHAR). As a co-editor he was the main driving force behind the joint WHO/IUPHAR/CIOMS publication titled Clinical Pharmacology in Health Care, Teaching and Research. Obituaries have been published in these
journals: Basic Clin Pharmacol Toxicol, Eur J Clin Pharmacol, Clin Pharmacol Ther and Ther Drug Monit, and on the website of Karolinska Institutet.
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CIOMS in the media
Dal-Ré R. Participants' written informed consent in low-risk pragmatic clinical trials with medicines. Expert Rev Clin Pharmacol. 2020;13(3):205‐210. (PubMed)
Gold MS, MacDonald NE, McMurtry CM, et al. Immunization stress-related response - Redefining immunization anxiety-related reaction as an adverse event following immunization. Vaccine. 2020;38(14):3015‐3020. (PubMed)
Reed M. Ethical Guidelines for Human Subjects Research in Least Developed Countries: How do they compare to the Council for International Organizations of Medical Sciences International Ethical Guidelines? [Electronic thesis). Tucson, AZ, United States: The University of Arizona; 2020.
Sanchini V, Devriendt T, Borry P. Anti-doping research and the Helsinki Declaration: (mis)match? Account Res. 2020;27(4):179-194. (PubMed)
Vera Porrello L, Reyes J, Delgado Colmenares T, et al. Análisis comparativo de las pautas del consejo de organizaciones internacionales de ciencias médicas (CIOMS) 2016. (Parte 1 de 3). [Comparative Analysis of the 2016 CIOMS ethical guidelines]. Rev Digit Postgrado. 2020 ; 9(1) : e200. (Journal; PDF full text )
CIOMS Secretariat
Secretary-General Dr Lembit Rägo Tel: +41 22 791 6410 [email protected]
Administrative Assistant Ms Sue Le Roux Tel: +41 22 791 6439* [email protected]
Technical Writers Ms Monika Zweygarth Tel : +41 22 791 6497* [email protected]
Ms Sanna Hill Tel: 041 22 791 6435* [email protected]
* Our offices are staffed during reduced hours due to the COVID-19 distancing measures. Please contact us by e-mail.
Upcoming meetings
Clinical Research in Resource-Limited Settings
8th Working Group meeting, 20–21 August 2020 (virtual meeting)
MedDRA Labelling Groupings
3rd Working Group meeting, 25–26 August 2020 (virtual meeting)
Working Group XII: Benefit-Risk Balance for Medicinal Products
3rd Working Group meeting, 08 - 09 September 2020 (virtual meeting)
Working Group XIII: Real-World Data & Evidence in Regulatory Decision-Making
3rd Working Group Meeting, 23 - 24 September 2020, Geneva, Switzerland
Working Group XI: Patient Involvement in the Development and Safe Use of Medicines
7th Working Group meeting, 20 - 21 October 2020, Amsterdam, Netherlands
