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©2022 American Medical Writers Association. All rights reserved.  
ISSN 2163-5315

AMWAJournal.org     9

This interview describes how the Good Lay Summary 

Practice guidance (GLSP) came into existence. Its devel-

opment had been initiated by a group of enthusiasts who 

wanted to provide guidance on how to plan, write, trans-

late, and disseminate lay summaries and on how to best 

involve patients into the process. The GLSP is the result of 

a multi-stakeholder initiative with more than 60 contrib-

uting organizations, comprising patients, patient organi-

zations, academic research networks, small and medium 

enterprises, and members from big pharmaceutical com-

panies. The initiative collaborated over more than 3 years to 

arrive at a final guideline that was then accepted into reg-

ulation. Major steps were the development of an organi-

zational structure consisting of a Core Management Team 

and 5 Task Forces that worked on the different topics, a large 

global public consultation of the draft document, and an 

intense discussion with the regulators in Europe. Dr Ingrid 

Klingmann, a physician, patient advocate, and cancer sur-

vivor, was at the helm of the Roadmap Initiative during the 

entire time and provides her insights on the challenges and 

results of this long and successful process.

Dr Ingrid Klingmann is a phy-

sician, patient advocate, and 

cancer survivor. She has been 

at the helm of the multi-stake-

holder Good Lay Summary 

Practice (GLSP) Initiative that 

developed a guidance for writ-

ing lay summaries. Lay sum-

maries are short documents 

understandable for the public 

that summarize the results of clinical trials. Lay summaries 

are now mandated for all clinical trials in the European Union 

(EU) based on European Clinical Trial Regulation (536/2014). 

They are also called Plain Language Trial Summaries, Patient 

Summaries, or Trial Result Summaries. Lay summaries are 

a novelty as they are the first regulatory documents that 

are meant to inform the public. Even more so, the GLSP 

Initiative was the first guidance that had been developed by 

a multi-stakeholder initiative that was then adopted as reg-

ulatory guidance. Some readers may be at odds with the use 

of the word ‘lay’ as for them it has a belittling connotation. 

However, as this is the official legal term in Europe, it has also 

been used in this article.

INTERVIEW
Schindler: Why did you and the European Forum for  

Good Clinical Practice (EFGCP) pick up the topic of lay 

summaries in 2018? At that time, several working groups 

had already been developing recommendations.

Klingmann: EFGCP had already been involved in the 

preparation of certain aspects of the European Clinical Trial 

Regulation. However, at that time there was no discussion 

on informing the public about the results of clinical trials. 

When the European Regulation was released in 2014, we 

were surprised to see the obligation to prepare lay summa-

ries for all clinical trials. Apparently, this topic had been 

added very late to the legislation. The mandate to inform the 

public in a systematic way about the outcomes of clinical 

trials triggered a lot of interest and excitement, and EFGCP 

and the European Federation of Pharmaceutical Industries 

and Associations (EFPIA) decided to organize a workshop.

 We wanted to clarify what it would mean for sponsors 

to prepare and disseminate lay summaries. During this first 

workshop in 2015, we became aware of the work of interna-

tional collaborations such as Multi-Regional Clinical Trials 

(MRCT) and TransCelerate. It became clear that stakehold-

ers would need more detailed guidance on the content and 

structure of lay summaries. When the European Expert 

Group issued their guidance on structure and content of 

lay summaries in 2017, we conducted another workshop 

Thomas M. Schindler, PhD  /  Boehringer-Ingelheim Pharma and Lay & Regulatory Writing, Biberach a.d. Riss, Germany 

The Making of the Good Lay Summary Practice Guidance: A 
Multi-Stakeholder Document That Was Adopted Into Regulation – 
An Interview with Dr Ingrid Klingmann

THEME ARTICLE

http://www.amwajournal.org


AMWAJournal.org     10The Making of the Good Lay Summary Practice Guidance

during which we reviewed their guidance. We realized that 

it was not enough to know about the requirements and best 

approaches to present the content, but that an overall pro-

cess for planning, preparation, translation, and dissemina-

tion was needed. Most importantly, producing lay summaries 

should involve patients in a systematic way. This aspect had 

not been included in existing guidances at the time. We had a 

very strong patient representation at this workshop, and they 

made it very clear that without patients, the process cannot 

be successful. As a conclusion from that workshop, EFGCP 

and EFPIA decided to create the “Roadmap Initiative to Good 

Lay Summary Practice” (the GLSP Initiative).

Schindler: What were the aims of the GLSP Initiative?

Klingmann: To bring together all the involved stakehold-

ers—so, commercial and academic sponsors, patients, 

patient organizations, not-for-profit organizations, medical 

writers, lay language specialists, and translators. We wanted 

to involve all viewpoints and existing experience to jointly 

develop guidance on how to set up an overall lay summary 

process. We needed a bit of time to get our act together, but 

then our road map initiative was kicked off in 2019.

Schindler: What were the biggest challenges in getting the 

initiative off the ground and keeping it afloat?

Klingmann: Well, there were a lot of challenges. Firstly, 

we needed to give the initiative an organizational structure 

and we needed to identify the topics to work on. In total, 

we had over 60 organizations from Europe and the United 

States who participated in the initiative. To more efficiently 

manage the process an international Core Management 

Team was formed. Initially, after a lot of discussion, we set-

tled on 5 task forces, each one led by a member of the Core 

Management Team and a patient or patient representative. 

The initial task forces were

1. Principles and processes of lay summary implementa-

tion beyond existing guidance.

2. Competencies required for development and transla-

tion of lay summaries.

3. Lay summary dissemination within and beyond the 

European Medicines Agency (EMA) Portal.

4. The issues of lay summary creation, translation,  

dissemination, and funding, particularly for academia 

and small and medium enterprises.

5. Suitable technology to reach patients, health care  

professionals, and the public including the develop-

ment of lay summaries for trials in children.

 It was difficult to get people to actively contribute to 

these different task forces. Participants were sometimes 

unaware that simply listening in was not going to help 

moving forward. The idea was to actively work out the  

content and to develop recommendations. Ultimately, we 

managed through a process of regular meetings, regular 

updates, and building up awareness in all the task forces 

to adhere to the timelines and to come up with proposals. 

In spring 2020, we had brought together a first draft of the 

GLSP that was then used in a very early discussion with 

the European Commission. They indicated that they were 

principally interested in collaborating toward a guidance 

and expressed that working on this aspect of transparency 

would be a good way to support the overall goals of the new 

European Clinical Trial Regulation. In line with the Core 

Management Team, the Commission supported the plan for 

a wide-spread public consultation on the draft in summer 

2020. It was agreed to reconvene thereafter.

GLOSSARY
CTEG – the Commission Expert Group on Clinical Trials. 
They provide the Commission with advice and expertise on 
clinical trials in relation to the preparation and implemen-
tation of legislation and policy initiatives. The CTEG is part 
of the Directorate Sante and consists of delegates from all 
national authorities and ethics committees in Europe.

EFGCP – the European Forum for Good Clinical Practice. 
They are a not-for-profit organization established by and for 
those with an interest in the development of medicines and 
medical technologies.

EFPIA – the European Federation of Pharmaceutical 
Industries and Associations. They represent the biophar-
maceutical industry operating in Europe.

European Commission – the executive branch of the 
European Union (EU). It operates as a cabinet government 
with 27 members (informally known as “Commissioners”) 
headed by a president.

European Clinical Trial Regulation – the binding law that 
specifies the rules for conducting clinical trials throughout 
the EU.

MRCT – Multi-Regional Clinical Trials. They are a research 
and policy center that wants to identify and deliver ethical, 
actionable, and practical solutions for the global clinical 
trial enterprise.

TransCelerate Biopharma – a not-for-profit entity with a 
mission to collaborate across the global biopharmaceutical 
development community to identify, design, and facilitate 
solutions designed to drive the delivery of new medicines.

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AMWAJournal.org     11The Making of the Good Lay Summary Practice Guidance

 The GLSP draft was posted on the EFGCP website and 

disseminated by all Roadmap Members to their networks. 

We received a high number of comments on the structure 

and a lot of detailed recommendations from all stakeholders. 

And of course, like always, after such a public consultation, 

it takes time to consider and discuss and agree on the com-

ments and write a revised draft. The workload associated 

with integrating the various comments and the preparation 

of a second draft was a major challenge for the initiative.

 In addition, much to our surprise, one of the key mes-

sages was that the document that we had produced was far 

too complex and too long (about 100 pages), especially for 

academic sponsors and investigators, and that we would 

need a type of summary. In response to this, the team devel-

oped the idea of having a “Quick Guide,” summarizing the 

principles and basic information, and a “Handbook” that 

contained the detailed guidance, recommendations, and 

experiences. And with that we went again to the European 

Commission. Keeping all stakeholders invested during the 

difficult discussions that ensued was a major challenge.

Schindler: Was it your idea to involve the European 

Commission at the draft stages?

Klingmann: Actually, it was an idea that was developed 

in the Core Management Team during one of our regular 

meetings. The team thought that the most effective way to 

support the implementation of good lay summary prac-

tice was a guidance that was issued by the regulators, ie, the 

European Commission. We believed that an official release 

and recognition would make it so much more powerful than 

when it was coming from a group of enthusiastic individuals 

who wanted to improve the world.

Schindler: In this long journey of the initiative, what 

were the moments of crisis? As a member of the Core 

Management Team, I remember a few. There were instances 

when it was difficult to keep the academic group engaged, 

and there were moments of distress when some colleagues 

in major pharmaceutical companies wanted to have some 

very specific points included. Most importantly, we had 

very critical discussions with the European Commission 

and the Clinical Trial Expert Group (CTEG).

Klingmann: Well, in fact, you listed them already quite cor-

rectly. I think the involvement of academia was an ongoing 

issue that came in different waves. Initially, it was difficult 

to get academia engaged at all because they were largely 

unaware of the new requirement. It became clear that the 

biggest issue for academia is that the writing of lay summa-

ries is a very late-stage activity in a clinical trial. At that time, 

funding is often no longer available because conduct-related 

activities have subsided and given current funding proce-

dures, writing a lay summary after the end of the project is 

not possible. Unfortunately, this situation is not solved. So, 

we agreed that we would also need to work with the large 

funding bodies to make them aware of the situation.

 When we had submitted the revised draft GLSP to the 

European Commission, they forwarded it to the CTEG for 

comments and review. Because CTEG is a group of 54 rep-

resentatives from national regulatory authorities and ethics 

committees of all European member states, we were afraid 

of receiving many comments and maybe even serious push-

back. And, as expected, we received a substantial number of 

comments and a list of several topics with which they were 

not in agreement. One problem was that they insisted that 

the GLSP must primarily be a European document because 

it relates to the European Clinical Trial Regulation. So, the 

need for lay summaries for patients in international and 

global studies and the need of patients all over the world 

to have access to these lay summaries was not a priority for 

them. It was quite a tough discussion, and it was difficult to 

find agreement. Some representatives of global pharmaceu-

tical companies were disappointed about this focus on the 

EU. However, building on the good will of all stakeholders, 

we were able to agree on a compromise.

 The second topic that the European Commission abso-

lutely did not want to go into was indirect dissemination—

that is, dissemination of lay summaries via company or 

third-party websites. They felt that it was not appropriate to 

provide guidance in the GLSP because currently there is no 

broadly agreed standard for this type of dissemination. Also 

here, some representatives of large pharmaceutical com-

panies were disappointed because they were hoping to get 

further guidance on how to disseminate lay summaries in a 

compliant way. In the Core Management Team, we agreed to 

tackle this topic again and work it out in full detail for another 

discussion with the regulators. This discussion in spring 

2021 was one of the most critical moments when it was really 

unclear whether we would come to an agreed document.

Schindler: You really contributed a lot to steer the initiative 

through these crises and you skillfully managed the inter-

action with the regulators—your professionalism was truly 

important for the success of the initiative.

Klingmann: Well, many people contributed to this—not 

only me—and many members helped to overcome diffi-

http://www.amwajournal.org


AMWAJournal.org     12The Making of the Good Lay Summary Practice Guidance

cult moments. In addition, the Commission and CTEG had 
appreciated that this was a multi-stakeholder initiative with 
strong patient involvement. They were willing to accept  
that they could have not created something better. Whatever 
they would have done could only have been top down, and 
probably not as relevant and practical as the document 
that we have produced. Finding agreement on the various 
topics of concern was often difficult, but many members of 
the initiative and the Core Management Team contributed 
to a good outcome. Remember, we had 9 months of intense 
interaction between all the road map stakeholders and the 
European Commission to come to a final document.

Schindler: For me, one of the most fascinating things is that 
the GLSP is a bottom-up multi-stakeholder initiative that 
made it into law.

Klingmann: Yes, it is unique that an initiative that was 
started by a group of enthusiasts who wanted to provide 
clinical trial data in an understandable way was recognized 
by regulators and turned into an official guidance. The final 
document is posted on the EudraLex website, which is the 
place where all European laws are published. I believe it 
was of critical importance that the initiative was driven by 
a neutral body, and I am proud that EFGCP could serve in 
this capacity.
 Another key factor was the ongoing substantial involve-
ment of patients in the initiative. The role of patients was 
very practically worked out throughout the entire guide-
line without avoiding the complexities that this may create 
sometimes. So, it was not Big Pharma or academia who 
drove this guideline, but it was the balancing of all the 
efforts of the different stakeholder groups in an open and 
fair way. For academic research and for small and medium 
enterprises, it was important to be offered a stepwise 
approach of implementing the GLSP.

Schindler: You have been at the helm of the initiative for 
more than 3 years. What does it take on a personal level to 
make such an initiative successful?

Klingmann: First of all and foremost, it takes a lot of time 
and energy. I was working philanthropically for the initia-
tive, and I still had to do my other work. During the intense 
phases, I had only very few weekends for myself. It requires 
a lot of energy to keep people engaged, which is some-
times difficult to muster. From time to time, I needed to give 
myself another push to advance the topic and to motivate 
the others and encourage them to deliver on the agreed 
topics. And of course, I was not alone in this. We were so 
lucky to have an exceptional group of dedicated individuals 

in the Core Management Team. Without their ongoing sup-
port and their critical input over several years, the initiative 
would have gotten nowhere. Also, I am very thankful for the 
ongoing support of all the members in the Task Forces and 
the entire initiative. 
 I believe we have a window of opportunity now to make 
the provision of lay summaries a part of the normal clinical 
trials process. With the COVID-19 crisis, there is so much 
interest in transparency and in the results of clinical studies. 
Our initiative will make those results more readily available 
for patients and the public.

Schindler: What are the next steps for the GLSP Initiative?

Klingmann: Most importantly we need to continue 
spreading the news about the availability of the GLSP to 
all parties that are potentially involved in the preparation 
of lay summaries. Webinars and workshops on a national 
level are planned. A next step could be to make the GLSP 
available in additional languages. The initiative is currently 
planning training programs for stakeholders and members 
of the public to learn about best practices in the prepara-
tion of lay summaries. And we will create an independent 
GLSP website that will become the central communication 
tool and repository for GLSP–related activities and content.
 Another key issue we need to tackle is to encourage 
academic researchers to fulfill the obligation of writing lay 
summaries, especially because about 40% of all trials in 
Europe are conducted by academia. We need to continue 
the discussion with the European Commission, particularly 
the Directorate-General “Research and Innovation” that is 
providing funding for a lot of academic clinical research. In 
addition, we need to continue to inform national funding 
organizations about the requirement to write lay summa-
ries and related resource needs. They need to change their 
requirements and their funding conditions to meet the costs 
associated with providing lay summaries.
 We want to re-initiate the discussion with the regula-
tors on the topic of indirect dissemination, ie, the option of 
sponsors to make lay summaries available on their websites. 
Although lay summaries are a European requirement, all 
patients in a global trial and the global public have the right 
to be informed about results regardless of their location. For 
this, we need to define the processes and develop an appro-
priate framework. And of course, the initiative should con-
tinue to provide a platform for best practices for example 

the provision of lay summaries for children.

Author declaration and disclosures: The author notes no com-
mercial associations that may pose a conflict of interest in rela-
tion to this article. 
Author contact: Lay_and_regulatory_writing@gmx.de

http://www.amwajournal.org


AMWAJournal.org     13The Making of the Good Lay Summary Practice Guidance

BIOS
Ingrid Klingmann, MD, PhD, FFPM, FBCPM
She is a physician specialized in clinical pharmacology 

with over 30 years of experience in different senior func-

tions in the pharmaceutical industry focusing on clinical 

trial design, ethical, and regulatory aspects. She owns and 

manages a pharmaceutical development and site man-

agement support consulting company since January 2003 

(Pharmaplex bv). The company creates networks of experi-

enced specialists that work on diverse international projects 

such as drug development consulting, study management 

for pharmaceutical companies, teaching projects, and 

academic site support. Dr Klingmann is Chairwoman of 

the Board of the EFGCP. Based on her broad professional 

background, she facilitates the alignment between stake-

holders in medicine development with the aim to develop 

patient-relevant treatments more efficiently.

 Dr Klingmann is currently also Secretary of the European 

Federation of Exploratory Medicines and President of 

PharmaTrain Federation (EUFEMED), a not-for-profit orga-

nization focusing on global standardization and improve-

ment of post-graduate training in medicine development. 

She teaches on topics like clinical research and regulatory 

affairs at the Universities of Bonn, Basel, and the Université 

Libre de Bruxelles.

Thomas M. Schindler, PhD
He is a biologist and linguist educated in Germany and the 

United Kingdom, holds a PhD in molecular physiology, 

and did postdoctoral research in the United Kingdom. He 

was the editor of popular science books in biology, geog-

raphy, and astronomy. He then turned to medical writing 

and has over 25 years of experience in both medical affairs 

and regulatory medical writing, including the preparation 

of marketing authorization application dossiers in different 

jurisdictions. He founded, established, and led the med-

ical writing function at Boehringer Ingelheim for almost 

20 years, and he has recently focused on lay summaries, 

video creation, and AI-driven writing. He participated in 

the TransCelerate Return of Results work stream, is in the 

Core Management Team of the GLSP Initiative and has sup-

ported the development of the Patient-Focussed Medicine 

Development (PFMD) Plain Language Summary guidance. 

For many years, he is the editor of the statistics section, 

“Statistically Speaking,” of the AMWA Journal.

A Career in 
Medical Communication:
Steps to Success
Learn about the skills and attributes needed 
to be a successful medical communicator 
and discover opportunities in the field.

www.amwa.org/career_steps

FURTHER READING
Directorate-General for Health and Food Safety. Good 
Lay Summary Practice Guidance. European Commission; 
2021. Accessed February 21, 2022. https://ec.europa.
eu/health/latest-updates/good-lay-summary-practice-
guidance-2021-10-04_en

European expert group. Summaries of Clinical Trial Results 
for Laypersons: Recommendations of the Expert Group. 
Version 2. Expert Group on Clinical Trials; 2018. Accessed 
February 21, 2022. https://ec.europa.eu/health/system/
files/2020-02/2017_01_26_summaries_of_ct_results_for_
laypersons_0.pdf

Aldinger C, Bierer BE, Collyar D, Li R, Myers L. MRCT 
Center Return of Aggregate Results to Participants Guidance 
Document. Version 3.1. Multi-Regional Clinical Trials 
Center of Brigham and Women’s Hospital and Harvard; 
2017. Accessed February 21, 2022. https://mrctcenter.org/
wp-content/uploads/2017/12/2017-12-07-MRCT-Return-
of-Aggregate-Results-Guidance-Document-3.1.pdf

Schindler TM. Lay summaries of clinical study results. In: 
Hall G, DeTora L, eds. Regulatory Writing: An Overview, 
Second Edition. RAPS; 2020:265-277.

Brauburger K, Sroka-Saidi K, Schindler TM. New European 
clinical trial regulation: the requirement for lay summa-
ries and its impact on medical communicators. Amer Med 
Writers Assoc J. 2015;30(2):60-63.

http://www.amwajournal.org
https://ec.europa.eu/health/latest-updates/good-lay-summary-practice-guidance-2021-10-04_en
https://ec.europa.eu/health/latest-updates/good-lay-summary-practice-guidance-2021-10-04_en
https://ec.europa.eu/health/latest-updates/good-lay-summary-practice-guidance-2021-10-04_en
https://ec.europa.eu/health/system/files/2020-02/2017_01_26_summaries_of_ct_results_for_laypersons_0.pdf
https://ec.europa.eu/health/system/files/2020-02/2017_01_26_summaries_of_ct_results_for_laypersons_0.pdf
https://ec.europa.eu/health/system/files/2020-02/2017_01_26_summaries_of_ct_results_for_laypersons_0.pdf
https://mrctcenter.org/wp-content/uploads/2017/12/2017-12-07-MRCT-Return-of-Aggregate-Results-Guidance-Document-3.1.pdf
https://mrctcenter.org/wp-content/uploads/2017/12/2017-12-07-MRCT-Return-of-Aggregate-Results-Guidance-Document-3.1.pdf
https://mrctcenter.org/wp-content/uploads/2017/12/2017-12-07-MRCT-Return-of-Aggregate-Results-Guidance-Document-3.1.pdf



