Ebook

Your Keys to
Understanding
EU Transparency

May 2022

Contents

EU Offers ‘Timely And Helpful’ Advice On Summarizing Trial Results For Laypersons

03

UK Kicks Off Landmark Overhaul Of Clinical Trial Framework

05

Pharma Firms Urged To Get Going On EU Lay Summaries

09

New Guide Offers Practical Insight Into EU Clinical Trial Lay Summaries

122

May 2022

Copyright ©️ 2022 Pharma Intelligence UK Limited, a Citeline company (Unauthorized photocopying prohibited)EU Offers ‘Timely And Helpful’
Advice On Summarizing Trial
Results For Laypersons
Vibha Sharma
Oct. 11, 2021

Executive Summary

With around three months left for the EU Clinical Trials
Regulation to fully kick in, the European Commission has
finalized much-awaited guidance offering practical insights
into how companies can comply with new transparency
requirements mandated under the legislation.

The European Commission has issued final
guidance explaining how sponsors can comply
with the upcoming mandatory requirement
under the EU Clinical Trials Regulation (CTR) to
publish lay summaries of clinical trial results
within specified timelines.
The CTR is due to apply from Jan. 31, 2022,
i.e., the date on which the new Clinical Trials
Information System (CTIS) goes live. Manycompanies have already started putting
processes in place in preparation for the laysummary-related requirement, which aims
to improve the transparency of clinical trial
information. (Also see “Pharma Firms Urged To

3

May 2022

Get Going On EU Lay Summaries” - Pink Sheet,Aug. 18, 2020.)
The publication of the good lay summary
practice (GLSP) guidance is “both timely andvery helpful,” said Lisa Chamberlain James,of the UK-based medical writing firm, Trilogy
Writing and Consulting. “We have certainly seen
an increase in companies needing help with Lay
Summary production ahead of the imminent
deadline,” she added.
The CTR requires sponsors to summarize andpublish trial results in the CTIS in a form that isunderstandable to laypersons. The lay summary

Copyright ©️ 2022 Pharma Intelligence UK Limited, a Citeline company (Unauthorized photocopying prohibited)EU Offers ‘Timely And Helpful’ Advice On
Summarizing Trial Results For Laypersons
must be submitted to the CTIS no later than 12
months from the protocol-defined end of theclinical trial, six months for pediatric studies,and up to 30 months for non-therapeutic Phase
I trials.
The GLSP guidance, published on 4 October,offers practical advice on how sponsors canprepare, write, translate and disseminate
summaries of clinical trial results in lay
language. It recommends that sponsors
organize the lay summary process into four
steps (planning, development, translation anddissemination) and proactively involve patientsin all aspects, where possible.
The importance of early planning forthis process, ideally during trial protocol
development or even when preparing a research
proposal and related budget, is emphasized
throughout the guideline.
“Whilst nothing is perfect and no guide canteach how to write, this guide is logical, clearlylaid out, and signposts to further information
and research if needed,” said Chamberlain
James, who is a senior partner at Trilogy. “Thisshould be the go-to guide for anyone starting
to work on Lay Summaries, or wondering what
they are all about.”
The guideline recognizes and addresses theneed for specific skills and strategies for lay
summaries on pediatric trials and highlights
the limited experience available so far. Visual
icons have been added throughout the guideline
to highlight aspects that are mandatory
under the CTR and to distinguish these fromrecommendations on pediatric lay summaries
that sponsors are encouraged to consider.

4

May 2022

On the readability front, for example, while the
CTR only specifies that trial result summaries
should be understandable to laypersons, theguideline recommends that a well writtensummary should normally be accessible byyoung people from the age of 12 years upwards.
The guideline encourages sponsors of pediatricstudies “to consider developing a child-focusedversion” of the lay summary for younger trial
participants “in addition to the version for theparents or legal representatives.”
The final guideline is the result of a multistakeholder initiative and consultation
process integrating the experience andrecommendations of over 60 international
industry, academia, patient and not-forprofit organizations. It was first adopted on 9
July by the EU Clinical Trials Expert Group, aworking group of the European Commission
representing ethics committees and EU national
competent authorities. (Also see “New Guide
Offers Practical Insight Into EU Clinical Trial
Lay Summaries” - Pink Sheet, July 28, 2020.)
The guideline incorporates several updates
based on stakeholder feedback. On the tricky
issue of the ideal length of lay summaries, forexample, the previous recommendation of“four to six pages” for trials with intermediate
complexity has been dropped altogether.
This has been replaced with a generic notethat a “readable document can be achieved
with a good layout and design for trials withintermediate complexity” while “more complex
trials may require more description.”
When the draft GLSP guideline was issued for
consultation, Chamberlain James said she had“high hopes for a well-researched, pragmatic,
and helpful guide.” The final guide, she said, met
her expectations. “I was not disappointed.”

Copyright ©️ 2022 Pharma Intelligence UK Limited, a Citeline company (Unauthorized photocopying prohibited)UK Kicks Off Landmark Overhaul
Of Clinical Trial Framework
Changes Affect Processes, Requirements& Timelines
Ian Schofield
Jan. 17, 2022

Executive Summary

The UK regulatory agency, the MHRA, is planning to establish
a “world-class sovereign regulatory environment” for clinical
trials to support the development of new innovative medicines.
In the first of two articles, we look at the MHRA’s proposals toslim down trial approval processes, lighten the safety reporting
burden, and introduce greater transparency of trial registration
and results.

The UK Medicines and Healthcare products
Regulatory Agency has launched a public
consultation to elicit stakeholder input on its
plans for a post-Brexit revamp of the clinical
trial regulations designed to make the UK “theleading global center for innovative research
design and delivery.”Among its plans are new maximum timelines forthe combined review of trial applications, more
flexibility on requests for information during
application review, greater transparency of trial5

May 2022

registration and results, and a lighter burden ofsafety reporting.
Other proposals, to be covered in a second Pink
Sheet article, address areas such as patient
involvement in trial design and management,
adherence to Good Clinical Practice,requirements for investigational medicinal
products, and changes to the rules on low
intervention trials.
This is the first major overhaul of the UK trial
regulations since the provisions of the EU

Copyright ©️ 2022 Pharma Intelligence UK Limited, a Citeline company (Unauthorized photocopying prohibited)UK Kicks Off Landmark Overhaul
Of Clinical Trial Framework
Clinical Trials Directive were transposed into
domestic law in May 2004. The ability to have its
own rules in this area has been widely flagged
up by the government as one concrete benefitof the UK’s decision to leave the EU.

“We aim to reframe the legislation that
underpins our regulation of clinical trials
to deliver a more streamlined, transparent
and flexible regulatory regime”– MHRA chief June Raine
Launching the eight-week consultation on 17
January, MHRA chief executive June Raine
described the initiative as a “once-in-ageneration opportunity to review and update
the UK legislation for clinical trials in order tomake the UK the go-to place to develop new
and innovative healthcare products.”“Through the proposals outlined in thisconsultation we aim to reframe the legislationthat underpins our regulation of clinical trials
to deliver a more streamlined, transparent
and flexible regulatory regime whilst always
protecting patients and trial participants,” Raine
said.
The changes will be implemented by updating
the Medicines for Human Use (Clinical Trials)
Regulations 2004, which transposed the EU
directive into UK law in May that year.
Plans to consult stakeholders on the proposals
were first announced at last year’s BioIndustry
Association-MHRA regulatory innovation
conference in December. Raine told drugsponsors at the time to “look forward to that
consultation, and get ready to engage.” (Alsosee “UK Plans Major Clinical Trial Legislation
Revamp” - Pink Sheet, Dec. 10, 2021.)

6

May 2022

Changes To Regulatory Requirements
As part of moves to streamline the clinical trial
approval processes, the MHRA is proposing togive legal shape to its new approach that tookeffect on 1 January, wherein sponsors have toapply for a combined regulatory and research
ethics committee (REC) review of their trial
applications.
This follows a pilot on a process that involved asingle application route and combined reviews
that was carried out last year and that theagency says is now to be embedded in thelegislation. (Also see “Combined Trial Reviews
To Become The Norm In UK From 2022” - Pink
Sheet, June 10, 2021.)
Key features of the proposed process include:• A single UK “front door” in the form of the“Integrated Research Application System”(albeit with the possibility to have separate
applications if justified).
• A streamlined appeal process with details
to be set out in guidance.
• New maximum standard timeframes forthe joint review and decision of 30 days
from receipt of the application, after which
an approval or a “Request for Information”(RFI) would be issued.
• For multinational trials, in order to minimize
or avoid UK-specific changes resulting from“non-concurrent assessment procedures”
at regulators in other countries, a“generous” 60-day period would be granted
to the sponsor to respond to any RFIs.
This would “facilitate the harmonizationof international protocols and betteralign requests for changes from multiple
regulators.”

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Of Clinical Trial Framework
The MHRA notes that the current legislation
does not explicitly allow a sponsor to withdraw
their trial application once the assessment has
begun, so it is proposing to allow withdrawal of
the combined MHRA/REC application “up until
the final assessment decision is issued, with aproportionate fee paid.”
Requests For Information
Requests for Information (RFIs) can be issued
by the MHRA or REC where information is
missing or changes are needed to the trial
application, but they can delay the application
process because assessment is suspended
until the sponsor provides a full response.
“Learning from clinical trials during COVID-19
has highlighted the opportunity for greater
flexibility in the formal communication between
applicants and regulators during the review of aclinical trial application,” the MHRA says.
It is therefore proposing that an RFI could be
issued relating to just one particular part of atrial, within a maximum timeframe (30 days
from receipt of the application). “This approach
worked well during COVID-19 on an informal
basis, and ensuring there are no blockers tothis in legislation would facilitate this option fora broader range of trials when appropriate,”
according to the agency.
RFIs could also be used to deal with substantial
amendments to a clinical trial, it suggests.
Safety Reporting
Some safety reporting requirements in clinical
trials “add burden to investigators but do
not contribute to patient safety,” the MHRA
observes. A number of changes are planned
here, such as:• Removing the requirement to reportindividual suspected unexpected serious
adverse reactions (SUSARs) to all
investigators. Instead, they would be
informed of safety information via theInvestigator’s Brochure, a comprehensive
7

May 2022

summary of clinical and non-clinical datacompiled throughout the study.
• Abolishing the requirement to report
SUSARs and annual safety reports to RECsin order to reduce duplicative reporting
requirements. Where justified, SUSARs
could be reported in an aggregate manner“provided that the trial protocol mandates
continuous monitoring of serious adverse
events/reactions.”• Placing a legal requirement on sponsors tohave a pharmacovigilance system aimed atperiodically reviewing accumulating safety
data to detect safety signals and propose
risk-mitigating actions.
• Removing the requirement to include
listings of serious adverse events andreactions in annual development safety
update reports (DSURs). The reports should
instead include an appropriate discussionof signals/risks associated with the use of
the product.
Transparency
On the transparency front, the MHRA plans anumber of moves to make sure trial information
is “publicly available for the benefit of all,”including legislating for “some of the researchtransparency provisions policies and processes
set out in the Health Research Agency’s ‘Make it
Public’ strategy to embed research transparency
in the regulation of clinical trials.”
There would be a requirement to register atrial in a World Health Organization-compliant
public register before it began, and to publish
a summary of the results within 12 months ofthe end of the trial (with deferral possible).
Trial findings would have to be shared withparticipants within 12 months. (Also see “UK To
Reveal How Sponsors Are Performing On Trial
Transparency Expectations” - Pink Sheet, Dec. 7,
2021.)To reduce burden on sponsors with respect
to registration, the HRA has started
automatically registering all new clinical trials of

Copyright ©️ 2022 Pharma Intelligence UK Limited, a Citeline company (Unauthorized photocopying prohibited)UK Kicks Off Landmark Overhaul
Of Clinical Trial Framework
investigational medicinal products (CTIMPs) into
the ISRCTN, a WHO-recognized global clinical
trial registry. (Also see “UK To Up Transparency
By ‘Auto Registering’ Trials” - Pink Sheet, Oct.
20, 2021.)

For example, regulators would be able to refuse
to approve a new study if there was “ongoingserious non-compliance with the legislation”
relating to an earlier trial and where there “could
be significant harm to participants.”

Sunset Clause
The legislation also allows a clinical trial
approval to remain valid indefinitely, despite
the fact that changes in medical practice, forexample, could have an impact on whether thedecision to approve the trial is still appropriate
in future.

The agency expects this would be rarely used,
but “as a regulator it is imperative that we areable to take action when absolutely necessary
to safeguard patients,” for example where
the non-compliance was “so serious that it
would result in regulatory action, such as an
Infringement Notice, termination of a trial or
possible prosecution.”

For this reason, the MHRA proposes to introduce
a sunset provision under which the approval
would lapse if no participants were included in
the trial within a specified period, for example
within two years of the trial approval. If thishappened the sponsor would need to apply foran extension.

“As a regulator it is imperative that weare able to take action when absolutely
necessary to safeguard patients”– UK MHRA
There are also plans to ensure that the MHRA’s
regulatory oversight is “both proportionate andstrong,” so the agency is considering “more riskproportionate correct measures.”8

May 2022

With regard to the suspension or termination ofa trial, and in view of “modern trial design,” itis proposed to remove the requirement for thewhole trial to be stopped if regulatory action istaken.
“Instead, we want to make clear that regulatory
action might apply only to a specific part of
the trial eg, recruitment, dosing, a specific armof the trial or related to a particular trial site,”the MHRA says. “This change would help ensurethat regulatory actions are proportionate andrecognizes the increasing use of innovative trial
designs.”

Copyright ©️ 2022 Pharma Intelligence UK Limited, a Citeline company (Unauthorized photocopying prohibited)Pharma Firms Urged To Get Going
On EU Lay Summaries
Encapsulating Clinical Trial Results For Patients
Is Not Easy
Vibha Sharma
Aug. 18, 2020

Executive Summary

The upcoming EU requirement for summarizing clinical trial
results in plain language is a real opportunity for companies
to engage with the public. But if companies don’t provide clear
and concise information, it may be reduced to a box-ticking
exercise.

The setting of a clear implementation date
for the EU Clinical Trials Regulation (CTR) has
sparked calls for appropriate compliance with a
new requirement in the legislation for companies
to publish lay summaries of clinical trial results.
There is a concern that without a clear focus
on ensuring that the lay summaries are “fitfor purpose” ― i.e., they provide clear, concise
information on clinical trial results in a nonpromotional manner ― compliance with the
obligation may become a pointless, box-ticking
exercise.

9

May 2022

The CTR is not expected to apply until December
2021, but there is already a wide mix in termsof how the industry is gearing up for the
new requirement. (Also see “EU Clinical Trials
Regulation To Apply From December 2021” Pink Sheet, June 16, 2020.)
Some companies are well prepared and havestarted producing lay summaries on a voluntarybasis. This has resulted in some great ―andsome not-so-great ― examples of how complex
clinical trial information can be summarized inplain language, said Lisa Chamberlain Jamesof the UK-based medical writing firm, Trilogy
Writing and Consulting.

Copyright ©️ 2022 Pharma Intelligence UK Limited, a Citeline company (Unauthorized photocopying prohibited)Pharma Firms Urged To Get Going
On EU Lay Summaries
But for some companies “it’s just not even on
their radar,” which Chamberlain James thinks “isa bit scary considering the time it can take forcompanies to set up the necessary processes.”
Her advice to such companies is to “get started”
and not “leave it until the last minute.”“It almost always takes longer than people
expect it to take,” said Chamberlain James,
who has worked with several drug companies
to help them develop templates and prepare
their systems to comply with the requirement topublish lay summaries.

“It’s not as easy as everyone thinks.” – Lisa
Chamberlain James, Trilogy Writing andConsulting.
While some companies can move faster thanothers, she explained that much depends onthe company’s size and work culture. Larger
companies may take longer as they usually
have a lot of management levels at which to getapproval and buy-in for new processes.
For companies that choose to do this inhouse, Chamberlain James recommends theyshould find somebody, either within or outside
the company, with the correct skill set andexperience to help. “It’s not as easy as everyone
thinks,” she said.
Describing complex clinical trial results in theright way, with the right level of context anddata, can be a “real challenge” because thestaff in regulatory departments traditionally
do not have to prepare information for theseaudiences, Chamberlain James told the Pink
Sheet. “You really need to start by training your[lay summary] reviewers… and that can taketime,” she added.
The complexity of the task can be gauged
from the fact that a recent multi-stakeholder
guideline on preparing concise, plain language
summaries of clinical trial results itself runs into10

May 2022

104 pages. The guideline, which is currently
out for consultation, includes feedback fromover 60 international patient organizations,
pharmaceutical companies, academic
institutions, not-for-profit organizations andcontract research organizations. (Also see “New
Guide Offers Practical Insight Into EU Clinical
Trial Lay Summaries” - Pink Sheet, July 28,
2020.)
Ridiculously Long
Lay summaries should ideally be as short as
possible. Although Chamberlain James has
prepared lay summaries that were just one
page long, she confesses these are “quite
unusual to be fair.”
Most of her lay summary documents are three
to four pages long. “Any longer than that, andonly the most committed patient will wadethrough the information,” she said.
Chamberlain James said she had seen lay
summaries running into eight to ten pages and“even longer,” which she thinks is “just crazy” asmost members of public will not read such long,overwhelming documents. It all then justbecomes a “pointless exercise,” she said.
The reason a lot of lay summary documents gowrong “is that they provide way too muchbackground” and extraneous information that is
not mandated by the regulation, she said. “Theirwriters should be questioning themselves if allof that information is really necessary… because
usually it’s not.”Besides brevity, there are other aspects thatmust be considered for producing fit-forpurpose lay summary documents, such as:• Checking readability: While user testing isstrongly recommended at various stages,
Chamberlain James said most companies
do not go in for full user testing because of
the time and budget implications. “There isa big variety of lay summaries out there,”
she said.

Copyright ©️ 2022 Pharma Intelligence UK Limited, a Citeline company (Unauthorized photocopying prohibited)Pharma Firms Urged To Get Going
On EU Lay Summaries• Non-promotional: The CTR requires lay
summaries to be non-promotional andunbiased, but there is no legal requirement
for these to be formally evaluated by theconcerned national competent authority.
Their public availability will make it possible
for the public to scrutinize them andreport any issue identified, the European
Medicines Agency told the Pink Sheet.
• Timeliness: The lay summaries must be
submitted no later than 12 months (sixmonths in case of pediatric trials) after
the end of a trial, which is defined as thelast patient last visit, or at a later point intime as specified in the protocol. The EMA
said it was difficult to be specific on whenexactly the first set of lay summaries would
become available under the CTR as thisdepended on a combination of factors,
such as the transition period and theapplication of disclosure rules to various
categories of trials.

11

May 2022

While there are still over 16 months left for the
CTR to come into effect, some companies haverealized that the lay summary requirement gives
them a real opportunity to engage with thegeneral public and to explain their studies.
These companies “have embraced theregulation” and created dedicated areas on
their websites for lay summaries “which isfantastic. While some are doing an excellent job,others not so much,” said Chamberlain James.
To support compliance, the European
Commission is planning to revise its 2018
guideline on lay summaries to provide further
details on their preparation and dissemination
based on feedback from stakeholders. (Also see“EU Fine-Tunes Guidance For New Clinical Trials
System” - Pink Sheet, July 17, 2020.)

Copyright ©️ 2022 Pharma Intelligence UK Limited, a Citeline company (Unauthorized photocopying prohibited)New Guide Offers Practical
Insight Into EU Clinical Trial Lay
Summaries
Vibha Sharma
July 28, 2020

Executive Summary

Sponsors are being urged to plan early and involve patientsin every aspect of preparing the plain language summaries ofclinical trial results that will become mandatory when the EU
Clinical Trials Regulation starts applying from December 2021.

A draft industry guideline on preparing laysummaries of clinical trial results, which
are mandated under the EU Clinical Trials
Regulation, recommends early, careful andproactive planning by sponsors to ensure thetimely delivery of high-quality and legallycompliant plain language summaries.

By planning ahead, the guideline explains,sponsors can align lay summaries with aspects
such as patient information sheets andinformed consent forms to ensure a coordinatedapproach across these documents and reduce
duplication of effort or the discrepant use ofplain language terminology.

The guideline on good lay summary practice(GLSP) ― which is the result of a multistakeholder initiative being jointly led by theEuropean pharmaceutical industry body EFPIA
and the Belgium-based think tank, theEuropean Forum for Good Clinical Practices(EFGCP) ― recommends that sponsors shouldcommence planning for lay summaries as earlyas the protocol development phase.

The draft GLSP guideline, on which comments
are being accepted until 14 September,has been developed to accommodate legal
requirements under the CTR, which is expected
to start applying from December 2021. (Alsosee “EU Clinical Trials Regulation To Apply From
December 2021” - Pink Sheet, June 16, 2020.)

12

May 2022

Copyright ©️ 2022 Pharma Intelligence UK Limited, a Citeline company (Unauthorized photocopying prohibited)New Guide Offers Practical InsightInto EU Clinical Trial Lay Summaries
It can also be used by pharmaceutical andacademic sponsors to meet their global
transparency commitments, for example
through voluntary dissemination of laysummaries beyond the EU/European Economic
Area. The guideline may also be of use tosponsors of non-interventional and medical
device trials, who are not legally required toissue lay summaries of their clinical trial results
but may decide to do so in the interest oftransparency.
Endpoints, Patient Involvement & Keeping
It Short
While the CTR requires lay summaries to include
the overall results of a trial, the guideline statesthat for most trials, a comprehensive discussionof all results would be neither feasible within aconcise document nor helpful to a non-scientificaudience due to the volume and complexity of
the information.
Although results from the primary endpointshould obviously be included in lay summaries,
the guideline acknowledges that there may
be merit in including results from secondary
endpoints that are particularly relevant forpatients. The inclusion of selective secondary
endpoints, however, “means that the sponsor
has to make a selection that could be biased.”As such, the guideline recommends limiting
the presentation of trial results to primary
endpoints to keep the lay summaries “shortand focused.” For sponsors who decide tosummarize secondary endpoints, it recommends
they should have a clear policy for planning nonpromotional, prospective selection of patientrelevant information to be consistent acrosstrials. Also within the lay summary, there should
be clear separation, in layout and in emphasis,
between the primary and the secondary
endpoints.
The guideline also offers practical advice on how
sponsors should use a patient-centric approach13

May 2022

to ensure that lay summaries are suitable,
relevant and can be successfully communicatedto the intended audience. It identifies tasks thatcan be performed by patients, depending on
their level of expertise, at all four phases of thelay summary process, namely:• Planning: Patients can be consulted to help
plan, identify and prioritize patient-relevant
outcomes and endpoints. Their contribution
may be particularly useful for sponsors
who are considering including secondary
endpoint information in the plain language
summaries.
• Development: Patients can help
identify content and terminology thatare potentially unclear, misleading or
unacceptable, and help develop alternative
language recognized within the patientcommunity.
• Translation: When lay summaries aretranslated into local languages, sponsors
should confirm their readability andunderstandability by native-language
patients or representatives of the public.
This can offer valuable insight into
any national terminology and culturalexpressions that may not otherwise be
identified during usability testing.
• Dissemination: Patients can offer input on
local dissemination, which may be subject
to cultural/sub-cultural practices, norms
or different acceptability levels acrossdifferent channels of communication.
Consulting patients with local insights canhelp avoid ineffective and inappropriate
dissemination efforts.
While it is generally recognized that lay
summaries should be as short as possible, theguideline states that for trials with intermediate
complexity “a readable document of four tosix pages can be achieved with a good layout
and design.” It recognizes that summaries ofmore complex trials may be longer as they may
require more description.

Copyright ©️ 2022 Pharma Intelligence UK Limited, a Citeline company (Unauthorized photocopying prohibited)New Guide Offers Practical InsightInto EU Clinical Trial Lay Summaries
The Need For Industry Guidance
The draft GLSP guideline has been developed
under the EFPIA-EFGCP Roadmap Initiative
for Good Lay Summary Practice, which waslaunched in January 2019. The initiative
took shape after it became apparent fromdiscussions held at workshops on this topic
in 2015 and 2017 that there was not enoughawareness among researchers, sponsors,patients, trial participants and health care
professionals about the requirement for lay
summaries in the CTR.
The initiative was established to work withrepresentatives from various stakeholder groups
to find a systematic, realistic and tangible

14

May 2022

approach to implement the lay summaries
by the date of application of the CTR. The
recommendations in the draft guideline
include feedback from over 60 international
patient organizations, pharmaceuticalcompanies, academic institutions, not-forprofit organizations and contract researchorganizations.
The GSLP guideline, when finalized, willcomplement the European Commission’s
guideline on the content of lay summaries,
which was revised in 2018. (Also see “Pharma
Requests Pilot To Test Public Value Of EU Guide
On Plain Language Summaries” - Pink Sheet,Aug. 16, 2017.)

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