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 Guidelines
The final ICH guideline E19 on the use and implementation of selective safety data collection in specific late-stage pre-approval or post-approval clinical trials has been implemented by the FDA. The current version was published on the EMA website Q4 2022; the date of coming into effect is 16 March 2023.
✍ EMA News
As of 31 January 2023, sponsors must submit all initial clinical trial applications under the CTR using CTIS and can no longer submit via the processes outlined in the Clinical Trials Directive. For trials authorized under the Clinical Trial Directive, sponsors can continue to submit substantial amendment following the principles of the Clinical Trial Directive until the end of the transition period on 31 January 2025.
✍ FDA Drugs & Biologics News
The US FDA recently released the following final guidance document:
- Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer, which provides recommendations for sponsors of investigational new drug applications (INDs) and biologics license applications (BLAs) under 42 U.S.C. § 262 and 21 CFR Parts 312 and 601 on the use of pharmacokinetic-based criteria to support the approval of alternative dosing regimens for PD-1 or PD-L1 blocking antibodies.
The ‘Report on the ClinicalTrials.gov Modernization Effort, Summary of Progress: 2021-22’ presents an update on the ClinicalTrials.gov Beta and PRS Beta websites, progress made on the modernization strategic goals, the modernization communication strategy, future modernization activities, and more. For more information, refer to https://clinicaltrials.gov/ct2/about-site/modernization.
✍ CORE Reference Project: TransCelerate CPT vs Draft ICH M11 Template
The CORE Reference Project Team has conducted an initial comparison of Levels 1 and 2 headings in the Transcelerate Clinical Template Suite (CTS) Release Addendum (version 009) versus the Draft ICH M11 template. The comparison showed minimal differences between the 2 templates in the structure of the main body sections. From Section 10 onwards, differences exist in the presentation of data. It should be noted that further changes are possible depending on feedback gathered during the public consultation period (up to 26 February 2023). The table of comparisons can be found at https://www.core-reference.org/media/1086/ich-m11-vs-tcel-cpt_by-core-ref_13dec2022-004.pdf.
✍ CONSORT- & SPIRIT-Outcomes 2022 Extension
Butcher et al. published reports on ‘Guidelines for Reporting Outcomes in Trial Reports: The CONSORT-Outcomes 2022 Extension’ and on ‘Guidelines for Reporting Outcomes in Trial Protocols: The SPIRIT-Outcomes 2022 Extension’. These extensions of the CONSORT 2010 statement (for reports) and of the SPIRIT 2013 statement (for protocols) provide outcome-specific items that should be addressed in all published clinical trial reports and protocols and may help increase trial utility, replicability, and transparency and may minimize the risk of selective nonreporting of trial results (see https://www.equator-network.org/reporting-guidelines/).
✍ Medical Devices
The EU Medical Device Coordinating Group (MDCG) released the following new guidance documents:
- MDCG 2022-21, Guidance on Periodic Safety Update Report (PSUR) according to the Regulation (EU) 2017/745 (MDR). The main objective of this guidance document is to assist manufacturers to implement the legal requirements laid down in Article 86 MDR.
- MDCG 2020-19, Performance study application/notification documents under Regulation (EU) 2017/746. This guidance document provides guidance on in vitro diagnostics (IVD) performance studies (ie, protocols for clinical studies for IVD). Templates are provided as Annexes.
- MDCG 2022-20, Substantial modification of performance study under Regulation (EU) 2017/746. This guidance document describes the process for IVD performance study modifications (ie, protocol amendments in clinical studies for IVD). Templates are provided as Annexes.