IN PARTNERSHIP I
n 2014, the EU introduced a new regulation: EU CTR 536/2014.1
This
regulation replaced the previous Clinical Trials Directive 2001/20/EC2
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’s drive towards transparency and openness, it included requirements for sponsor companies to produce a Lay Summary of Clinical Trial Results, and 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 information clearly and concisely, without being biased or promotional in any way, and that is also understandable 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 discussed in more detail in the latest Questions and Answers document (version 6.2), which was issued by the authority in September 2022.3
These requirements are extensive and
include a maximum page allowance. This article will look at the requirements for
the Protocol Synopsis in lay language and discuss if it is 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
“Protocol Synopsis content requirements were discussed in more detail in the latest Questions and Answers document (version 6.2), which was issued by the authority in September 2022.3 These requirements are extensive and include a maximum page allowance”
considered to be, but it does outline the nine sections that should be included in the synopsis, with some description:3 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 end points: describe the main trial end points and when they are assessed, eg, the main trial end point is the percentage change in the number of events from baseline to reactions at a particular time after baseline. 5. Secondary trial end points: describe the
secondary trial end points, and when they are assessed, eg, number of adverse events until 30 days post end of treatment. 6. Trial design: describe the design and
the expected duration of the trial for the individual subjects, eg. double-blind placebo- controlled clinical trial where subjects are participating for X weeks. 7. Trial population: describe the trial population, indicating the main inclusion criteria
Outsourcing in Clinical Trials Handbook | 11
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100
