Regulatory Dr Lisa Chamberlain James
Dr Lisa Chamberlain James is a senior partner and CEO of Trilogy Writing & Consulting. Aside from management activities, she leads client projects, with extensive experience in a variety of documents. Chamberlain James has a special interest in writing for the public, and in patient information. Following a PhD and post doc. in Pathology at Cambridge, she began her medical writing career in 2000. Since then she has been involved in EMWA as a member of the Educational Committee, mentor, leader, and assessor of workshops, and teaches and reviews workshops for AMWA. The CEO holds an EMWA professional development certificate, is a member of TOPRA, DIA, and PIPA, initiated and chaired the EMWA PV and Communicating with the Public Special Interest Groups, is chair of the Geoff Hall Scholarship Committee, section editor of the ‘Medical Communications and Writing for the Public’ section of Medical Writing, and is a Fellow of the Royal Society of Medicine.
8. Interventions: describe interventions and treatment duration, also including background treatment if any
9. Ethical considerations relating to the clinical trial including the expected benefit to the individual subject or group of patients represented by the trial subjects as well as the nature and extent of burden and risks. A benefit-risk analysis should be done for the trial-specific treatments and interventions, clearly explaining if the trial involves an expected individual benefit or a group benefit. When a trial is placebo-controlled, a brief justification should be given. If a non-therapeutic trial is carried out in vulnerable groups, their inclusion also has to be justified and it should be explained why the risks and burden are considered minimal and why the trial can only be performed in this particular patient group. The trial-specific risks and burdens for subjects and caregivers (if applicable) related to diagnostic, therapeutic and monitoring procedures should be justified.
Furthermore, unlike the lay summary of clinical trial results, the protocol synopsis has a required maximum page limit of two pages.
Laying it all out
Aside from the general challenges of writing for the general public (which are outside of the scope of this article), there are a number of specific challenges associated with the protocol synopsis requirements as set by the authority.
There is no guidance about how much background should be given in section two, or how many secondary objectives should be given in section three (the implication being that all of them should be included). The objectives as well as the main and secondary trial endpoints (which must be described in sections four and five) can be very complex and take a large amount of space to explain in plain language, a problem that is compounded by the requirement to not only describe but state the time frame of the assessments. The trial design and population (sections six and seven) can also be very complex and potentially confusing, and are often most easily explained using infographics, which can work very well but do take up a lot of space.
Section seven also requires the inclusion and exclusion criteria to be described, which can be extensive, involving a lot of complicated clinical and technical terms and assessment criteria. A description of the inclusion and exclusion criteria in clinical regulatory language often takes a page alone (and we must consider that extra words are often necessary to explain concepts in plain language),
14
In partnership with Trilogy Writing & Consulting
and the requirement to include a description of the background treatment and trial related diagnostic and monitoring procedures (section eight) could be extremely lengthy depending on the therapy area. Similarly, section nine’s requirements for an ethical discussion and a benefit-risk analysis would be extremely challenging to condense into a meaningful, plain language document.
The document as a whole Considering that the guidance on the requirements of the protocol synopsis runs to a page and a half on its own, and that in general it takes more words (and therefore space) to explain complex concepts in plain language, the two-page limit would make a fit for purpose document almost impossible to achieve for all but the most simple of studies.
This is a great shame (and cause of much frustration) because arguably a plain language protocol synopsis is most needed for more complex studies. Some companies are ignoring the recommendation completely. Some are exploring the use of a glossary to allow them to circumvent the two- page limit by adding explanations of terms and abbreviations to a separate document. Unfortunately, this not only risks uncoupling the glossary from the main text, but also requires the reader to do quite a lot of memory work and cross referencing, just to be able to understand the document – surely the opposite of what any plain language document, but especially the protocol synopsis, is trying to achieve. However, the authority must be applauded for recommending a version of the protocol synopsis in lay language. The concept is sound – providing a simplified, easy to understand summary of how and why a study was done for the general public is needed and necessary. Additionally, the protocol synopsis could and should form a great basis for the lay summary of clinical trial results document and the plain language used in the Informed Consent Form could be brought forward to both documents, minimising effort and simplifying the messaging for the general public.
A suggested page limit is a very sensible strategy to avoid long, convoluted, unclear documents (whether in plain language or not), but I fear that having a strict limit disincentivises companies to even try to produce these documents in plain language – the task in many cases is just too daunting, if not unachievable. My hope is that the authority allows some flexibility on this page limit. Surely it would be better to have a three-page protocol synopsis that is clear and understandable, than a two-page document that the public cannot understand. ●
References available upon request. Clinical Trials Insight /
www.worldpharmaceuticals.net
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
