Regulatory
lay protocol synopsis
The
The EU Regulation 536/2014 included a requirement for companies to produce a protocol synopsis with a recommendation for a version in lay language. This stated, among other things, a maximum length of two pages. Here, CEO of Trilogy Writing & Consulting Lisa Chamberlain James outlines the requirements of the regulation with respect to the protocol synopsis, and discusses the feasibility of them in light of the maximum page limit.
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n 2014, the EU introduced a new regulation: EU CTR 536/2014. This regulation replaced the previous Clinical Trials Directive 2001/20/EC and became mandatory with the opening of the Clinical Trials Information System (CTIS) on 31 January 2022.
The new regulation was introduced to ensure that the rules for the assessment of clinical trial applications and the conduct of clinical trials were identical throughout the EU. There were many new aspects introduced by the regulation and as part of the European Medicines Agency (EMA)’s drive towards transparency and openness, it included requirements for sponsor companies to produce a lay summary of clinical trial results and also a recommendation for a protocol synopsis in lay language. Both of these requirements have caused much discussion in the industry, because they called upon a completely different writing skill set. For the first time, companies were required to explain complex scientific and clinical information clearly, concisely, without being biased or promotional in any way, while writing in a manner that is also comprehensible to the general public. The content requirements of the lay summary of clinical trial results are outlined in full in Annex V of the regulation, but in contrast, the protocol synopsis is only mentioned in one line in Annex 1 (D.24), which states simply, “the protocol shall be accompanied by a synopsis of the protocol”. In response to requests for more guidance, the protocol synopsis content requirements were
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discussed in more detail in the latest question and answer document (version 6.2), which was issued by the authority in September 2022. These requirements are extensive and include a maximum page allowance. With these requirements in mind, is it feasible to produce the document as required?
What is the protocol synopsis? Quite simply, the protocol synopsis is a summary of the main aspects of the protocol and there is a recommendation from the authority to produce a version in language that is “understandable to a layperson”. The latest guidance does not state what a layperson is considered to be, but it does outline the nine sections that should be included in the synopsis, with some description: 1. EU trial number and full trial title 2. Rationale: specify background and hypothesis of the trial
3. Objective: specify the main and secondary objectives of the trial
4. Main trial endpoints: describe the main trial endpoints and when they are assessed
5. Secondary trial endpoints: describe the secondary trial endpoints, and when they are assessed
6. Trial design: describe the design and the expected duration of the trial for the individual subjects
7. Trial population: describe the trial population, indicating the main inclusion criteria including age and disease/healthy volunteer and the main exclusion criteria to protect the subject
Clinical Trials Insight /
www.worldpharmaceuticals.net
In partnership with Trilogy Writing & Consulting
Keigo K/AdobeStock
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