This month, we are delighted to introduce a new section to the CORE Reference News Summary – ‘Transparency and Disclosure (T&D) for Medical Devices’. Content will be supported by Raquel Billiones and the EMWA Medical Device Special Interest Group (MD-SIG). The Medical Device Regulation (EU) 2017/745 (MDR) comes into force on 26 May 2021; T&D is one of the foundation stones of the MDR. CORE Reference is a unified ‘go-to’ information source that cuts across all interventions (medicines, vaccines, devices), so device-specific T&D information will be disseminated via email (sign up at https://www.core-reference.org/subscribe to receive information in ‘real time’) and in the monthly CORE Reference News Summaries (https://www.core-reference.org/news-summaries/). This scope expansion supports the continuing education of medical writers across the industry.
To ensure we reach the broadest of audiences, the drugs, biologics, vaccines, and medical devices T&D combined information will appear:
- In monthly EMWA NewsBlasts emailed to members of www.emwa.org
- On the EMWA Regulatory Public Disclosure Special Interest Group (RPD SIG) Webpage at:
In addition, the medical devices T&D information may appear separately on the EMWA MD SIG Webpage at: https://www.emwa.org/sigs/medical-devices-sig/ and the Medical Device Section of the EMWA journal MEW.
Sam Hamilton (Chair)
Art Gertel (Strategist)
for the CORE Reference Project
Medicines and Vaccines
EMWA's RPD SIG 'Meet & Share' – Friday 02 July 2021, 13:30 CET
The EMWA Regulatory Public Disclosure Special Interest Group (RPD SIG) are holding their first Meet & Share event on Friday 02 July at 13:30 CET. Topics for discussion include two new requirements once the European Clinical Trials Regulation EU No 536/2014 becomes fully applicable:
1) Lay person summaries of clinical trial results;
2) Redaction of key clinical trial documents which will be made publicly available, e.g., protocol, IB, CSR.
Please join this session to share information and learn from each other.
Closer to the date, registration details for the Zoom meeting will be shared.
Call for Publication of Unredacted CSRs
The International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) are urging pharmaceutical companies to publish clinical trial reports for new medicines and vaccines without redactions to ensure that research results are publicly accessible to all those involved in healthcare decision-making. In a joint statement, they stress that systematic transparency can increase trust in regulatory decision-making, reassure the public about data integrity and can stimulate research and development.
FDA adopt E9(R1)
FDA have, in May 2021, adopted E9(R1): 'ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials'. Final FDA Guidance is here.
One of the major topics of the E9(R1) guidance is estimands. CORE Reference - which has been downloaded over 32,000 times to date - references E9(R1) and the topic of estimands. Further, in this publication authored by our team, we present Table 2 - a downloadable worked clinical study example including estimand.
The importance of intercurrent events and estimands in clinical trials has received recent attention because trials running through the COVID-19 pandemic must consider these important statistical concepts. Medical writers can better understand the concept behind 'estimand' from this paper published in MEW.
Transparency and Vaccine Hesitancy
This Nature News article describes the outcomes of the April 2021 KFF COVID-19 Vaccine Monitor poll. Transparency around communicating vaccine risk information appears to bring challenges to the vaccination effort.
This publication by John Kerr and colleagues explores how transparency around COVID-19 vaccines may impact behaviours. The results from two online experiments indicate that “… transparently informing people of the limitations of vaccinations does not reduce intentions to be vaccinated but neither does it increase intentions to engage in protective behaviours post-vaccination.”
eICF Implementation Guide
EUCROF - the European CRO Federation - have published the document, Electronic Informed Consent Implementation Guide Practical Considerations. This implementation guide “…offers a combination of practical considerations from stakeholders, an updated landscape overview of eConsent in today’s world, with an outlook on the current regulations and the impact of COVID-19 on demand for eConsent.” This document has cross-functional utility; as Medical Writers responsible for preparing Clinical Study Protocols (CSPs) and Clinical Study Reports (CSRs) that must capture eConsent processes and procedures, we are well placed to share this resource with colleagues.
Video on ICH Guideline Development Process
The Clinical Trials Transformation Initiative have produced a video to enhance transparency around the ICH Guideline development process. It is presented by members of the ICH E6 Expert Working Group (EWG) and contextualises the Efficacy or ‘E‘ family of guidelines relevant to design and conduct of clinical trials. The relationship between ICH E8 clinical trial design principles and ICH E6 clinical trial conduct principles is clarified, and it is explained that the two guidelines should be viewed as a continuum and should be used together as they are highly complementary.
This video is included on a comprehensive webpage which presents the ‘ICH E6 Guideline for GCP - Update on Progress’ event held on 18 and 19 May 2021 as a virtual meeting.
26 May 2021 marked the day when the EU Medical Device Regulation (MDR) 2017/745 came into application. T&D has been underserved in the medical device sector but the MDR and the accompanying implementation guidance documents are going to change this. To kick start this CORE Reference update on Medical Devices, we would like to share links to key resources that highlight the current state of T&D in the field of medical devices.
Open access articles on devices T&D published in the EMWA journal MEW in the last 4 years:
- Dunlevy F, 2017. Transparency – left to its own devices until now. Med Writ. 2017;26(2):29–31.
- Billiones R, 2017. Medical devices in the disclosure era and the role of medical writers. Med Writ. 2017;26(2):32-34.
- Billiones R and Thomas K, 2019. Medicinal products and medical devices in clinical trials conduct and disclosure –and never the twain shall meet! Med Writ. 2019;28(2):74-80.
- Billiones R, 2020. Eudamed's delay and its impact on disclosure of clinical investigations under the EU MDR.. Med Writ. 2020;29(3):12-15.
Regulations, standards, and guidance documents for medical devices that provide information on T&D requirements:
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (EU MDR).
Excerpts from Article 73. Electronic system [EUDAMED] on clinical investigations [=clinical trials]
“The Commission shall, in collaboration with the Member States, set up, manage and maintain an electronic system … for clinical investigations… [certain] information … shall be accessible to the public… No personal data …shall be publicly available.”
Excerpts from Article 77. Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination “… the Commission may issue guidelines for the formatting and sharing of raw data, for cases where the sponsor decides to share raw data on a voluntary basis… The summary and the clinical investigation report [= CSR]… shall become publicly accessible through the electronic system... In cases of early termination or temporary halt, the summary and the report shall become publicly accessible immediately after submission.”
Also refer to Annex XV Clinical Investigations for more details.
- ISO14155: 2020. Clinical investigation of medical devices for human subjects — Good clinical practice.
Section 5.4 Registration in publicly accessible database
“In accordance with the Declaration of Helsinki, a description of the clinical investigation shall be registered in a publicly accessible database before the start of recruitment activities and the content shall be updated throughout the conduct of the clinical investigation and the results entered at completion of the clinical investigation.”
- Fact Sheet on MDR requirements for Transparency and Public Information by the European Commission DG Health and Food Safety July 2020.
- Draft Functional Specifications for the European Database on Medical Devices (EUDAMED) - First release (High(1)) to be audited, 28 Feb 2019.
- DCG 2021-1. Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional. Mar 2021.