White Paper

Trial Summaries
Improving Patient‐Centric Communications

July 2023

Contents

Executive Summary3

Introduction

4

Business Challenge

6

Proposed Solution

8

Business Benefits
Trial Participant Benefits
Sponsor Benefits999Summary

10

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Trial Summaries: Improving
Patient‐Centric Communications

Executive Summary
Clinical trial sponsors continue to be faced withnumerous challenges as they work to improve
patient education and engagement throughout
the clinical research process. These interactions
have a direct impact on a trial participant’s
perception of the care they are receiving in aclinical trial as well as their overall satisfaction
with the experience.
Pressure to improve communications and to
expand transparency efforts continues to comefrom trial participants, patient advocates,
researchers and industry transparency
advocates. As the complexity of clinical3

July 2023 

research continues to grow, so does the need tocommunicate more efficiently and effectively
with trial participants and the general public.
This paper discusses the challenges inherent in
the current practices of providing trial resultssummaries to trial participants. It presents analternative approach to distributing trial resultssummaries that takes advantage of commonlyused technologies to more quickly, efficiently
and reliably provide trial results summaries totrial participants. The benefits of this approach
to clinical trial sponsors, patients, and theirrelationship with each other are also discussed.

Copyright ©️ 2023 Citeline, a Norstella company. (Unauthorized photocopying prohibited).

Trial Summaries: Improving
Patient‐Centric Communications

Introduction
Trial results summaries, often referred toas plain language summaries, are brief
explanations of an individual clinical trial
written in easily understandable language.
Trial results summaries differ from theinformation typically posted on ClinicalTrials.
gov or the EU Clinical Trials Register in that the
information is less technical and geared towarda different audience. The objective of a trial
results summary is to effectively communicate
pertinent information in a clinical trial including
the trial population, investigational medicinal
product and the overall results. The audience
for this document is primarily trial participants;
therefore, the language used should be non‐technical in nature and easy to understand.
Trial sponsors are increasingly focusedon patient engagement, with a growing
understanding that sharing results of clinicalstudies with the trial participants is the
ethical thing to do. In addition to the evolving
transparency policies, plain language trial
results summaries are required by law in certain
regions. The European Clinical Trial Regulation(EU No. 536/2014) requires sponsors to provide
a clinical trial results summary that will be
published in an EU‐wide database. Annex Vof the regulation provides an outline for thecontent of the trial results summary as noted
below.
Annex V of the European Clinical Trial
Regulation1:
The summary of the results of the clinical trial
for laypersons shall contain information on thefollowing elements:

Content of the Summary of the Results of theClinical Trial for Laypersons
1.	Clinical trial identification (including title ofthe trial, protocol number, EU trial number
and other identifiers);
2.	Name and contact details of the sponsor;
3.	General information about the clinical
trial (including where and when the trial,
was conducted, the main objectives of thetrial and an explanation of the reasons for
conducting it);
4.	Population of subjects (including informationon the number of subjects included in thetrial in the Member State concerned, in theUnion and in third countries; age groupbreakdown and gender breakdown; inclusionand exclusion criteria);
5.	Investigational medicinal products used;
6.	Description of adverse reactions and theirfrequency;
7.	Overall results of the clinical trial;
8.	Comments on the outcome of the clinical
trial;
9.	Indication if follow-up clinical trials areforeseen;
10.	Indication where additional information
could be found.
The concept of clinical trial transparency has
evolved to include trial participants as a key
stakeholder and identifies them as a criticalaudience whose data must be presented in adifferent, non‐technical and non‐promotional
format. The timetable below illustrates theevolution of clinical trial transparency toward
patient‐centric communications.

1. Regulation EU No. 536/2014 on clinical trials on medicinal products for human use, Annex V
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014R0536

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Trial Summaries: Improving
Patient‐Centric Communications

Important Dates in the Evolution of Patient-centric Transparency
Year

Event

2000

Launch of ClinicalTrials.gov

2001

EU Directive 2001/20/EC specified the creation of EudraCT for clinical trial
registrations

2007

FDA Amendments Act required posting of trial results for approved products on
ClinicalTrials.gov by 20082012

European Commission required posting of technical summary results for trials
conducted in at least one EU member state on EudraCT; functionality to support thisis available in 20142013

Pharmaceutical Research and Manufacturers of America (PhRMA) and the European
Federation of Pharmaceutical Industries and Associations (EFPIA) publish acommitment by member companies to publish clinical trial results summaries for
products approved in the US and EU

2014

European Clinical Trial Regulation Article 37 required sponsors to provide clinical trial
results summaries in a format understandable by laypersons to be made available in
the EU Portal and database

2015

Policy 0070 became the publication of clinical study reports (CSRs) and clinicalsubmission documents by the EMA

2017

Effective date of the FDA Amendments Act Title VIII Final Rule2018

Launch of the EU Portal, including access to the trial results summaries

2018

EMA’s policy 0070 temporarily suspended

2021

US FDA takes first enforcement action on trial reporting, with a notice ofnoncompliance to Acceleron Pharma2022

https://pink.pharmaintelligence.informa.com/PS145602/Here-At-Last-A-New-EraFor-Clinical-Trials-In-The-EU EU Clinical Trial Regulation takes effect Jan. 31 and theClinical Trials Information System (CTIS) for reporting study information goes live

2022

The World Health Organization (WHO) proposes to harmonize how the summary
results from clinical trials are reported in registries

2023

Sponsors are mandated to report new clinical trial applications into EU’s CTIS
starting Jan. 31

2023

Health Canada announces plans to create a new clinical trials search portal

2023

Phased re-start of the EMA’s policy 0070

2025

As of Jan. 31, all ongoing trials that had been approved under the previous EU
Clinical Trial Directive must be transitioned to CTIS

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Trial Summaries: Improving
Patient‐Centric Communications

Business Challenge“Care should be taken to ensure thatthe lay summary is made available ina nonpromotional context.”

Clinical trial sponsors have an ethical obligation
to provide clinical trial results summaries
to trial participants. Trial volunteers are thebackbone of clinical research and should betreated as such throughout the clinical trial
process. Current practices often do not help
sponsors fulfill their ethical, corporate andlegal obligations and commitments in a reliable
manner.

The context in which the information ispresented is critical to the use and effectivenessof a trial results summary. Some clinical trial
sponsors post their trial results summaries on
their own branded websites. This allows thesponsors to maintain control over the content
from creation to publishing. However, postingtrial results summaries to a branded website
poses its own challenge, because the website
is typically designed to promote the sponsor’s
products, creating an environment in which site
visitors may perceive the trial results summaries
as making claims about efficacy and safety.

Sponsors must efficiently and accurately
communicate trial results information to trial
participants. This requires that trial resultssummaries are:
• Created using language that is easily
understood by the general public• Distributed in a timely manner• Made available in a non‐promotional,
unbiased context
Most sponsor teams have spent time focusing
on the content of the trial summaries to ensure
they are meaningful and easily understood.
However, few sponsors have assessed theircurrent practices for getting this information to
the intended recipient. Effective distribution andavailability in a non‐promotional context are
major challenges that are often still overlookedat the patient’s expense.
TransCelerate, a nonprofit organization
comprised of biopharmaceutical companies,
published 12 recommendations for using non‐promotional language in trial results summaries.
One of the recommendations, also supportedby the Federal Drug Administration (FDA) andMulti-Regional Clinical Trials (MRCT) Center,addresses the context in which a trial resultssummary is published:

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The next challenge lies in the mechanism forgetting the trial results summaries to trial
participants. Traditional methods rely on studysite staff to mail paper copies of trial results toparticipants once the trial is completed. Thistypically happens about a year after the study
closes. Often, the trial documentation at thesite has been archived and must be requested
from offsite storage in order to obtain contact
information for trial participants. Particularly forlarger trials, this can be a very time-consuming
and tedious task. Since this usually occurs
a year later, quite often, trial participants
may have relocated in the interim so resultssummaries that are mailed are returned tothe study staff or distributed without any
confirmation of receipt.

Copyright ©️ 2023 Citeline, a Norstella company. (Unauthorized photocopying prohibited).

Trial Summaries: Improving
Patient‐Centric Communications

CISCRP, The Center for Information and Studyon Clinical Research Participation, is a nonprofit
industry organization founded in 2003 anddedicated to engaging the public and patientsin the clinical research process. CISCRP is a
proponent of developing trial results summaries
communication programs that improve
volunteer patient experiences. The organization
has done research on patient communications
and has reported the following:• 88% of trial volunteers would participate ina clinical trial again2• The top way (46%) that people reportfinding out about a trial is via the internet2• 91% of participants wanted to know theresults of their clinical trial, yet only 8.9%

had been able to find out, even thoughtechnical results had been posted toClinicalTrials.gov for over two months.3
The ability to access trial results summaries
has a significant impact on the health literacyof clinical trial participants. The logistics ofmaintaining contact information, distributing
trial results summaries, and the actual
responsibility for managing the informationis left in the hands of study site staff. Thistakes ownership and access to critical healthinformation away from trial participants. Thisless‐than‐ideal scenario plays out around theworld every day. Information is not received at
all or not received in a timely manner.

2. CISCRP Clinical Research Charts and Statistics
3. 2021 Perceptions and Insights Study, https://www.ciscrp.org/services/research-services/perceptions-and-insights-study/

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Trial Summaries: Improving
Patient‐Centric Communications

Proposed Solution
Providing trial results summaries in a timely
manner is a great way to acknowledge
trial participants’ contributions. It enables
participants to understand the trial and use thedata collected about their health. Responsible
sharing of trial results summaries is a generally
accepted guiding principle in the industry. In fact,
in 2013 the PhRMA and EFPIA jointly publishedPrinciples for Responsible Data Sharing4 which
described member commitments as:“In order to help inform and educate
patients about the clinical trials in which
they participate, biopharmaceuticalcompanies will work with regulators to
adopt mechanisms for providing a factual
summary of clinical trial results and makesure the summaries are available toresearch participants.”

In order to fulfill these commitments, it isimportant for clinical trial sponsors to leveragetechnology to replace current paper‐based
practices and to present trial results summaries
in a non‐promotional context.
Citeline’s Trial Summaries portal takes
advantage of the common accessibility of theinternet to connect patients to their trial resultssummaries. The Trial Summaries portal is aneasy-to-use website where clinical trial sponsors
can post trial results summaries for patients andthe general public to access.
Patients in a particular trial can subscribe toreceive email reminders about the trial resultssummaries and their availability once the trial iscomplete.

4. PhRMA & EFPIA Joint Publication, 2013

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Trial Summaries: Improving
Patient‐Centric Communications

Business Benefits
For trial participants and clinical trial sponsors, there are numerous benefits to this simplified
approach.
Trial Participant Benefits• The Trial Summaries portal demonstrates to trial volunteers that their participation isappreciated and important to the clinical research process.
• It facilitates improved understanding of trials by making the results summaries readily
available via the web.
• This approach facilitates patient engagement and education while reducing the delays inherent
in traditional paper‐based processes.
• The ability to subscribe to trial results summaries empowers the trial participants to manage
the frequency and amount of information they want to receive in follow‐up to the study.
• Trial participants can always access their trial results summaries online; no need to keep trackof a paper copy.
Sponsor Benefits• The Trial Summaries portal supports clinical trial sponsors’ ethical, corporate and legal
obligations to communicate trial results to trial participants.
• The Trial Summaries portal provides a direct and controlled channel for sponsors to publish trial
results summaries efficiently, thus ensuring alignment with other approved disclosure content.
• The portal offers a non‐promotional and unbiased context in which the trial results summaries
are presented.
• This approach eliminates costly, time‐consuming, unreliable, and rarely tracked paper-based
distribution through study site staff.

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Trial Summaries: Improving
Patient‐Centric Communications

Summary
Trial results summaries are an important deliverable in the clinical research process. As clinicalresearch continues to expand and become more complex, plain language communications become
increasingly important to patient education and engagement. A web‐based solution such as
Citeline’s Trial Summaries portal provides a compelling alternative to ineffective and unreliable
processes that demand an upgrade to a new standard of practice.

Improve Communications
Contact the experts at Citeline to learn more about the Trial Summaries portal and how you can
improve patient engagement end education.

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July 2023

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