Advisor 469

CLINICAL RESEARCH • CLINICAL QUALITY ASSURANCE

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• the secondary use of data • complex trials • a risk-based approach.

• proportionality and added value in relation to monitoring and source data verification • interaction between the ICH and international patient and healthcare professional groups • simplifying consent and providing guidance on the use of electronic informed consent • involving more than one investigator and/or institution in the treatment of a single patient • including patients in trial design and the review of patient information • increasing the participation of elderly patients in clinical trials (eg. through the use of new technologies). Copies of the workshop presentations are available online. MHRA issues guidance on new rules following the transition period The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a collection of guidance documents detailing the rules on medicines and medical devices that must be followed from 1 January 2021. From 1 January 2021, the MHRA will be the UK’s stand-alone medicines and medical devices regulator. The UK will offer fully independent regulatory decisions for devices and pharmaceuticals, both nationally and in joint work with other international regulators. Stakeholders need to be ready for the new rules and the MHRA has issued a collection of guidance documents on medicines and medical devices for the industry and other organisations. The guidance also covers product licensing, clinical trials, pharmacovigilance procedures, and importing medicines and investigational medicinal products. Source:

Oncology trials The European Organisation for Research and Treatment of Cancer (EORTC) explained the perspective of a non-profit cancer clinical research organisation, noting that E6(R3) should be approached as a patient topic and not as a medicines issue, and should cover the entire continuum from (early) drug development to applied clinical trials. The revision is seen as an opportunity to re-engineer a holistic continuum of research from innovation through to therapeutic strategy, rather than separating the two. EORTC suggested some challenging changes, including the following: • ensuring that changes to GCP are driven by the diversity of clinical trials and clinical questions rather than by the regulatory industry model • considering how participants in clinical research could ‘unlearn’ what has been done before and do things differently, creating completely new concepts • using the available resources to “raise quality not documentation” • refocusing on the intention of informed consent and providing alternative ways of achieving consent • changing how protocol amendments are implemented • encouraging remote and proportionate monitoring • reducing bureaucracy by limiting data collection, including reduced serious adverse event reporting. Discussion topics Other topics discussed included the following: • debate on and harmonisation in the compensation of clinical trial participants • involving ethics committees in writing E6(R3), particularly to ensure that the requirements add value and are proportionate • enabling larger clinical trials to involve a wider participant population • training patients

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Issue 469, 2020

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