The newsletter provides a summary of recent news or key updates in the field of medical writing and relevant for our business activities. Information is selected from various sources such as the EMWA, AMWA, ICH, EMA, US FDA, and European Commission websites.
We hope you find the newsletter informative!
ICH published the latest glossary compiled by the Council for International Organizations of Medical Sciences; the glossary includes the terms and definitions from across ICH guidelines (https://cioms.ch/publications/product/glossary-of-ich-terms-and-definitions/#description).
EMA updated ‘Guidance document on how to approach the protection of personal data and commercially confidential information while using CTIS’. This revision (v1.1) added Section 4 on the management of commercially confidential information (CCI) in clinical trial information submitted to CTIS and Section 5 on Good Clinical Practice (GCP) inspection reports, and updated Annex I (overview of expected personal data contained in referenced documents/fields). Annex II provides a template for GCP inspections carried out to category 1 trials where the publication of clinical trial information is delayed by a deferral (https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-information-system-training-support#protection-of-personal-data-and-commercially-confidential-information–section).
EMA published a report on their experience in conducting studies with real-world data (RWD) in the period from September 2021 until 7 February 2023. The data indicate that real-world evidence (RWE) from regulator-led studies can complement other evidence (eg, from clinical trials) and can support pre-authorization and post-approval assessments. The report is available at https://www.ema.europa.eu/en/documents/report/real-world-evidence-framework-support-eu-regulatory-decision-making-report-experience-gained_en.pdf.
EMA will resume its policy for publication of clinical data included in marketing authorization applications from September 2023. An update of the ‘Clinical Data Publication (CDP) Questions and Answers (Q&As) on the External Guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use (Policy 0070)’ (Rev. 3) is available.
The European Network of Paediatric Research at EMA updated the ‘Informed Consent for Paediatric Clinical Trials in Europe 2015’ guidance. Refer to https://www.ema.europa.eu/en/documents/other/informed-consent-paediatric-clinical-trials-europe-2015_en.pdf for more information.
FDA DRUGS & BIOLOGICS NEWS
The US FDA published the final guidance documents:
· ‘Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drugs and Biological Products’, discussing the applicability of FDA’s investigational new drug application regulations (21 CFR part 312) to clinical study designs using RWD, and clarifying the agency’s expectations regarding effectiveness and safety for clinical studies using RWD that are not subject to 21 CFR part 312.
· ‘Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors’, intended to assist IRBs, clinical investigators, and sponsors in complying with informed consent regulations for clinical investigations.
· ‘Clinical Drug Interaction Studies With Combined Oral Contraceptives Guidance for Industry’, intended to help sponsors of INDs/NDAs.
For the final guidance document ‘Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs, 2 guidance snapshots were created: one for patients and one for sponsors (https://www.fda.gov/drugs/guidances-drugs/guidance-snapshot-pilot).
The ‘Oncology Quality, Characterization, and Assessment of Real-world Data (QCARD) Initiative’ aims to improve the quality of initial RWD study proposals by evaluating the potential minimum elements for sponsors to consider when assembling submissions for review of a proposed study and RWD source(s) (https://www.fda.gov/about-fda/oncology-center-excellence/oncology-quality-characterization-and-assessment-real-world-data-qcard-initiative).
The modernized ClinicalTrials.gov website is now available.
The ISO has published a plain language standard to improve communication in different sectors. ISO 24495-1:2023 ‘Plain language – Part 1: Governing principles and guidelines’ features high-level principles, guidelines, and techniques to help writers everywhere produce communications that work (https://www.iso.org/standard/78907.html).
Regulation (EU) 2023/607 amended the EU MDR and EU IVDR with regard to the transitional provisions for certain medical devices and in vitro diagnostic medical devices. The new regulation allows certain legacy devices (depending on class) to remain in the market until 2027/2028.
Two papers on designing estimands were published. Cro et al. found that public partners want to be involved in estimand discussions and describe the co-development of a tool to facilitate these discussions (https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07469-9). Englert et al. provide a framework for defining estimands in single-arm Phase 1b or Phase 2 oncology studies (https://pubmed.ncbi.nlm.nih.gov/37403434/).
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