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.
EU CTR 536/2014 Q&A Update
The Clinical Trial Regulation (EU) No 536/2014 Questions & Answers Version 6.7 has been published. Changes and updates compared to the superseded version are outlined in the document history on the front page (including additional clarification related to safety reporting, see https://health.ec.europa.eu/system/files/2023-12/regulation5362014_qa_en_0.pdf). This Q&A document should be read in combination with the updated ‘Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation’ (Version 2).
CTIS
A quick guide for users on revised CTIS transparency rules, interim period, and historical trials has been published. The guide provides a summary of structured data and documents that will be published, including timing, and of the updated ACT EU Q&A on the protection of commercially confidential information (CCI) and personal data when using CTIS (v1.3).
EMA
The European Medicines Agency (EMA) revised its general guidance on anonymization of protected personal data (PPD) and assessment of CCI during the preparation of Risk Management Plans (RMPs), main body and annexes 4 & 6 (Revision 1). This guidance document includes information on which PPD should be retained, generalized, or deleted, and a non-exhaustive list of items that may be considered CCI.
RWD
Formal protocolized Real World Data (RWD) studies can provide robust evidence for safety signal assessment in addition to pharmacovigilance databases, clinical trial data, and scientific literature. However, these RWD studies are often resource and time intensive. The Rapid Signal Assessment Using Real World Data (RSA RWD) Initiative offers an RSA RWD Framework and an alternative to a full protocol for RSA, and helps to address resource and time constraints of traditional safety assessment (https://www.transceleratebiopharmainc.com/assets/rapid-signal-assessment-using-real-world-data-solutions).
FDA
The US Food & Drug Administration (FDA) published the following final guidance documents:
· Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products, which provides considerations for sponsors proposing to design a new registry, or use an existing registry, to support regulatory decision-making about a drug’s effectiveness or safety.
· Data Standards for Drug and Biological Product Submissions Containing Real-World Data, which addresses considerations for the use of data standards currently supported by FDA in applicable drug submissions containing study data derived from RWD sources.
The US FDA published a final rule allowing an IRB to waive or alter elements of an informed consent when a clinical investigation poses no more than minimal risk to the human subject. The agency added new § 50.22, “Exception from informed consent requirements for minimal risk clinical investigations” to part 50 and made 3 conforming amendments to §§ 50.20, 312.60, and 812.2 (21 CFR 50.20, 312.60, and 812.2) of the current regulations (https://public-inspection.federalregister.gov/2023-27935.pdf).
CONSORT & SPIRIT Factorial
The CONSORT 2010 statement (for reports) and SPIRIT 2013 statement (for protocols) have been extended to include information for factorial trials (in which 2 or more interventions are assessed in the same set of participants) to increase the trial’s utility and transparency. The SPIRIT extension modified 9 of the 33 items in the SPIRIT 2013 checklist. The CONSORT extension modified 16 of the 37 items in the CONSORT 2010 checklist and adds 1 new item (https://www.equator-network.org/reporting-guidelines).
Artificial Intelligence (AI)
The HMA-EMA Big Data Steering Group created a multi-annual workplan on AI to facilitate the development and use of responsible and beneficial AI. The workplan focuses on 4 critical dimensions (guidance, policy, and product support; tools and technologies; collaboration and change management; and experimentation) and will be regularly updated.
Medical Devices
The EU Medical Device Coordinating Group (MDCG) released the following guidance documents:
· MDCG 2021-6 Rev.1 Q&A regarding Clinical Investigation, which provides clarifications on clinical investigations for medical devices and on clinical studies for drug-device combination (DDC) products; the newly added annex helps to determine which regulations apply to different types of DDCs.
· MDCG 2023-7 Guidance on Exemptions from the Requirement to Perform Clinical Investigations, which clarifies the exemptions from the requirement to perform clinical investigation, and associated conditions related to the demonstration of equivalence.
The US FDA announced that eSTAR is now available for voluntary use for the following Premarket Approval Applications (PMAs) submission types:
- Original PMAs
- PMA Panel Track Supplements
- PMA Real-Time Supplements
- PMA 180-Day Supplements
eSTAR an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission.
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