Advisor 469

CLINICAL RESEARCH • CLINICAL QUALITY ASSURANCE

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u • two key annexes, one for interventional trials and one for non-traditional interventional clinical trials, including those incorporating real world data sources. The revision will aim to avoid overinterpretation and to focus on key concepts such as quality by design, risk-based approaches, proportionality and critical to quality factors. Wider engagement Currently, no patient or healthcare professional organisations are involved in the ICH, although the ICH would welcome an international patient organisation and an international healthcare professional organisation as official ICH observers in the future. In the meantime, through a series of engagement steps with identified stakeholders, it is hoped that the guideline will be responsive to the needs of those conducting or participating in clinical trials. Survey The Clinical Trials Transformation Initiative survey gave stakeholders an opportunity to provide feedback to the ICH’s update of E6; 60% of respondents were in the EU. The detailed results are already available and indicate that the broad areas requiring the most focus are those related to sponsors (monitoring), essential documents and investigators. The need for flexibility, simplification and updating to accommodate changes in research conduct and technology, as well as to clarify terms and concepts, was also highlighted. The results show a demand for transparency and inclusiveness, with clear requests for the inclusion of a wide variety of stakeholders in the review process and transparency around the creation of the renovation. Expert Working Group The workshop presentation by the ICH E6(R3) GCP Expert Working Group noted that more needs to be done to increase the number of patients engaged in the design of trials. In particular: • informed consent forms (ICFs) are getting longer and less comprehensible to the layperson;

guidance is needed on how patients can confirm they understand the information and agree to trial participation • study endpoints may not be those that are most important to patients • mobile phones and wearables that are part of patients’ daily lives could be better used for data collection • participants are often burdened with numerous tests, some of which may not support key trial endpoints and require increased visits • trials should be more patient-centric with, for example, some visits happening in the patient’s home. Patient organisations are keen to contribute to E6(R3). This is critical as it will be important to explain all the changes to patient organisations and to patients in general. The revision provides an opportunity to define a global standard on patient engagement in clinical trials. Investigator perspective The meeting highlighted that investigators want increased patient safety and reduced bureaucracy in clinical trials, particularly with respect to safety reporting, the comprehensibility of ICFs and regulatory ambiguity. Improvements in ICFs will only happen if patient organisations are involved in their writing. Concerns were also raised about the tendency of sponsors and contract research organisations to over-interpret GCP guidelines, which impacts the initial aim of optimising patient safety. More clarity about how, who, where and when to implement recommendations would be helpful, eg. by having abbreviated guidelines running alongside the revised full version. Non-commercial organisations The European Clinical Research Infrastructure Network is a non-profit organisation that supports certain types of multinational trials in Europe. During the workshop it reported on the challenges faced by non-commercial organisations as a result of changes in trial design and data use relating to • personalised medicine research u page 5

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Issue 469, 2020

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