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!
CTIS
An updated version of the ACT EU Q&A on the protection of commercially confidential information and personal data while using CTIS (v1.3) has been published. The document includes updates pertaining to the new transparency rules released earlier this year and their implementation in CTIS. All relevant information on transparency can be found at https://euclinicaltrials.eu/guidance-and-q-as/#qas-transparency.
EMA News
The European Medicines Agency (EMA) will relaunch its website on 5 December. The new corporate website of the EMA features a new, simple medicines search, clearer navigation, and a revamped ‘What’s new page’. The content from the previous version of this website will still be available, including EMA’s bank of information on medicines. Former addresses (URLs) – such as links to pages and documents – will still work.
‘COMBINE’ Project
The ‘COMBINE’ project was launched in June 2023 by Member State competent authorities for clinical trials and medical devices and the European Commission to address challenges encountered by sponsors when conducting combined studies (ie, a clinical trial of a medicinal product in parallel with a clinical investigation of a medical deviceor a performance study of an in vitro diagnostic) and require application of Regulation (EU) 536/2014 together with Regulation (EU) 2017/745 or 2017/746. For more details refer to https://health.ec.europa.eu/medical-devices-topics-interest/combined-studies_en.
ICMRA (10 Years)
This year marks the 10th anniversary of the International Coalition of Medicines Regulatory Authorities (ICMRA). ICMRA was established in 2013 by 8 regulators to address a need for a global governance mechanism and stronger cooperation. Today, ICMRA consists of 38 members, with the World Health Organization as an observer. ICMRA is currently chaired by the European Medicines Agency (EMA) with co-chairs from ANVISA Brazil and PMDA Japan. Read more news at https://www.ema.europa.eu/en/news/global-regulators-celebrate-10-years-strategic-leadership-and-cooperation.
FDA Drugs & Biologics News
The US Food & Drug Administration (FDA) published the following final guidance documents:
- ‘Submitting Patient-Reported Outcome Data in Cancer Clinical Trials’, which provides technical specifications for submitting patient-reported outcome (PRO) data collected in cancer clinical trials to support a marketing application for a medical product in oncology, where a PRO is a type of clinical outcome assessment (COA) used to collect patient experience data.
- ‘Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory, which provides technical specifications for the submission of COA data that use Item Response Theory and supplements the Patient-Focused Drug Development Methodological Guidance Series. A COA refers to the assessment of a clinical outcome made through a report by a clinician, a patient, a non-clinician observer, or through a performance-based assessment: clinician-reported outcome (ClinRO), patient-reported outcome (PRO), observer-reported outcome (ObsRO), and performance outcome (PerfO) measures.
- ‘Real-time oncology review pilot (RTOR)’, outlining the eligibility and submission requirements for applicants interested in submitting new drug applications (NDAs) or biologics licence applications (BLAs) with oncology indications for review under RTOR.
- ‘COVID-19: Developing Drugs and Biological Products for Treatment or Prevention’, which provides the Agency’s current recommendations for phase 2 and phase 3 trials with a focus on trial population and design, efficacy endpoints, as well as safety and statistical considerations. This supersedes the final guidance issued in 2020 and reissued in 2021.
Artificial Intelligence (AI)
Plain Language Summaries generated by AI are now available for nearly 50,000 clinical trial results onClinicalTrials.gov. The company who generated the summaries cautions that while the use of AI to produce the initial summary can save time, “the use of AI is not a complete replacement of a skilled human writer”. The company plans to add more trial summaries in the future, and to automatically generate a plain language summary whenever a new record is made available on ClinicalTrials.gov, on a daily basis. Read the full story here: https://www.transparimed.org/single-post/pls-automated.
Medical Devices
The US FDA issued the final guidance document: ‘Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions’, which provides recommendations on a risk-informed framework for credibility assessment of computational modeling and simulation used in medical device regulatory submissions.
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