Empowering, Enabling and Assisting Patients - Enhancing Patient Enrollment in Clinical Trials with
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Empowering, Enabling and Assisting Patients
Enhancing Patient Enrollment in Clinical Trials
with
© admedicum® Business for Patients GmbH & Co KG
What do we stand for?
“Patients should be treated as experts in
what it is like to live with their condition
and that they can provide great insights
in the understanding of the therapeutic
context for drug development and
evaluation.” C D E
ENTER FOR R (CDER) - FDA
RUG VALUATION AND ESEARCH
We are committed to ensure optimal incorporation of the patients’ voice in drug
development to achieve optimized, meaningful and faster treatments to patients
© admedicum® Business for Patients GmbH & Co KG 2021 2
The inconvenient truth of running clinical trials
23 % of patients 30 % of patients
unhappy with site do not consent due to
location lack of understanding
>30 % of patients 4 out of 5 sites
drop-out before study
failing to enroll to target
ends
30 % of trials 40 % of budget
are cancelled due to
goes to recruitment
insufficient participation
Source: Medidata
© admedicum® Business for Patients GmbH & Co KG 2021 3
What aspects do we need to address?
Patient Burden Recruitment Strategy
• Unnecessary long travel times for • No awareness creation using all
patients due to site locations available channels (including landing
• Unnecessary long duration of study pages, social media, cross-border, etc)
visits or study visits too frequent • Insufficient patient companion services
Study Design Patient Communication
• No reality check whether the patient • Sub-optimal layman / patient-friendly
(per in/exclusion criteria) exists? and fully understandable information
• Unnecessary or suboptimally organized prior (to recruit), during (to retain) and
(practical/logistical) study procedures after the clinical trial (to endorse)
© admedicum® Business for Patients GmbH & Co KG 2021 4
Our perspective on patient engagement in clinical trials
Disease Protocol Pa�ent Recruitment
Awareness Facing Strategy / Trial
Materials Awareness
Listen to patients,
learn from patients
Pa�ent Pa�ent Inves�gator Site
Monitoring Recruitment Mee�ng Selec�on and co-create with
Commi�ee / Concierge patients while
preparing, executing
Pa�ent Study Layman
and reporting your
Study Outcomes Study clinical trials
Updates Review Report
Pre-study
Pa�ent
Results Prepara�on study phase
Mee�ng Execu�on study phase
Repor�ng study phase
© admedicum® Business for Patients GmbH & Co KG 2021 5
Our perspective is fundamentally different from other stakeholders
Connecting all the dots
is the basis for success
in your clinical trial!
Benefit
Uncertainty
Is this the right choice for me?
Do I miss any opportunities in the future?
Are there any costs? Are there any alternatives? Fear
Can I quit?
What if it does not work?
What are my responsibilities?
Do I have an individual point of contact?
Risk
Hope
© admedicum® Business for Patients GmbH & Co KG 2021 6
Our approach to enhance patient enrollment in clinical trials
gy
ate
es
s Str ss /
ren nt
t
en ne r t nt
a tie itmware ato i en itmee
Aw Pa cing rials u tig g t
Pa cru ierg
e ol r
c A e ion s
e n
se
as
otoc Fa ate Re rial Sit lect Inv eeti Re onc
Di Pr M /T Se M C
Creating awareness through community landing pages and social media campaigns
Tailor study protocols to significantly lower patient burden, address logistical &
practical challenges and perform patient mapping vs in/exclusion criteria
Create & check patient facing materials from the perspective of the patient to
improve understanding
Provide patient-friendliness site selection assessments to optimize site selection
from patient perspective
Provide adequate patient perspective training during Investigator Meetings and
ensure optimal performance of the patient2site activities towards sites
Technology combined with unmatched patient engagement services to create
successful patient recruitment strategies, trial awareness and boosted enrollment
© admedicum® Business for Patients GmbH & Co KG 2021 7
to empower, enable and assist patients
Enable
pa�ents to “We put the patients in
find clinical
trial sites by the driver seat to fit
tailor-made
landing pages their needs and boost
clinical trial recruitment ”
Assist pa�ents
by providing
an unmatched
pa�ent
companion
Empower
service pa�ents to
access clinical
trials that fit
their needs
© admedicum® Business for Patients GmbH & Co KG 2021 8
the process | 4 steps to enhance enrollment
Building custom-made
community landing pages to
create awareness
Launching social media
ENABLE
SELECT campaigns which are
INFORM continuously monitored in
FIND order to adapt towards success
Process is fully regulatory compliant in order to obtain efficient ethics approvals Involving Patient Advocacy
Groups (PAGs), Health Care
Providing unmatched patient companion services for patients to
• easily find a suitable study that fits their needs
Professionals (HCPs) and/or
• adequately get informed to be abe to select a trial site Social Media patient
• enable them to get in contact with a selected trial site champions
© admedicum® Business for Patients GmbH & Co KG 2021 9
Building a central online gateway (1)
Information for patients,
1 family & friends
2 Pre-Screening checks
eligibility
3 HCPs are informed
© admedicum® Business for Patients GmbH & Co KG 2021 10Building a central online gateway (2)
• Patient landing page
• Target group: First patients, their relatives and friends; second their treating and potentially referring physicians (oncologists)
• Lay friendly Information: Easy to understand and navigate
• URL: create own website
• Linked to other related websites, e.g. www.clinicaltrials.gov, www.clinicaltrialsregister.eu
• Doc-Check protected HCP landing page
Content:
• Information on treatment
• Information on trial program
• Referral information
• Patient information
• Contact form
Access protection
© admedicum® Business for Patients GmbH & Co KG 2021 11Patient recruitment flow
Online
Awareness campaigns by
Patient Landing Page **
Google, Facebook & Co.
Site A
Trustworthy social
media patient bloggers
Offline
Awareness Site B
by PR & Video
Engagement Study website Patient companion service
*
Outreach to HCPs and online pre-screening Site C
Patient organizations ***
* Patients may ask for their treating physicians view
** Some patients will go directly from landing page to site
*** Some patients are sent directly by HCP to site
© admedicum® Business for Patients GmbH & Co KG 2021 12Role of the investigators
• Important to have one key investigator to give his/her name/picture and a quote or a video on the Patient Landing
Page to increase credibility
• Other than that investigators will be relieved from recruitment task
• Patients will come to them, they can stop thinking of a potential match or reaching out to regional colleagues
• Investigators should be aware of the change of process and prepare their site for expected increase of
applications/screenings
Ideally sponsor, CRO, sites and admedicum all work
through central gateway patient landing page
(to provide for online pre-screening and patient
companion follow-up)
© admedicum® Business for Patients GmbH & Co KG 2021 13key differentiators
Developed and implemented by patient Modular set-up which makes it ideally
engagement experts together with patients suited to rescue patient recruitment in
slow or non-recruiting studies
Audited GCP / FDA & IT-Security Turns around standard
compliant online recruitment process & recruitment workflow and puts
technology patients in the driver seat
Embedded in our full suite of patient engagement
services to provide a holistic approach on involving
patients in drug development
© admedicum® Business for Patients GmbH & Co KG 2021 14Reference case studies
Phase I Phase II Phase II Phase III
Rare Cancer Sexually Transmitted Disease Infectious Disease Rare Neuromuscular Disease
Blutkrebs-Studie.de Genitalherpes-Studie.de Lippenherpes-Studie.de dmd-epidys.com
© admedicum® Business for Patients GmbH & Co KG 2021 15Case study: Blood cancer trial (1) | Multi-modal program
Online Recruitment Program
Study: TCR therapy study in Acute
Myeloid Leukemia (AML) &
Myelodysplastic Syndrome (MDS) patients Videos / Audio
(study phase I) Patient landing page SEA
Location: Germany (multiple languages)
Multi-Modal Program: Ranging from a Patient Influencers
full Online Recruitment Program to a level
HCP landing page FB-Ads
1 & 2 physician referral system, and
Regional (around clinical trial sites) and
Nation-wide Public Relations www.blutkrebs-studie.de
Patient Organisations Lay PR
© admedicum® Business for Patients GmbH & Co KG 2021 16Case study: Blood cancer trial (2) | Viral video
Story: Decision-making process of a
cancer patient to participate in a
clinical trial
Purpose: Attention to clinical trials
for the treatment of blood cancers
Production: Co-created and
professionally produced with
patients and patient organizations
https://www.youtube.com/watch?v=vSpDr5cn66s Video End: Link to more
information including online
Quotes from patients and relatives recruitment page
“I was really touched…”
“Gives me goose bumps…” Social Media: Published on
various channels (over 65k views)
“ The video means a lot to me”
© admedicum® Business for Patients GmbH & Co KG 2021 17Case study: DMD trial | Creation of a landing page
Co-creating a patient
Study: HDAC inhibitor therapy in landing page with patients
and PIs that includes
Duchenne’s Muscular Dystrophy (DMD) online pre-screening and
patients (randomized, double-blind patient companion service
placebo-controlled phase III study) Designing information
materials with input from
patients and PIs (e.g. flyer,
Location: Germany checklist)
Launching a landing page
Creation of a Landing Page: Ranging for physicians (DocCheck
access protection)
from creation of all information from
patient perspective, obtaining necessary “Approval of all materials by the respective Ethical
approvals to full dissemination and Committees on first submission”
online promotional campaigns Joint dissemination of trial information through
patient organizations, social media influencers and
referring physicians & promoting the website via
online awareness campaigns
© admedicum® Business for Patients GmbH & Co KG 2021 18Selected testimonial
“We have found that the team at Admedicum and Trials24 has a solid understanding of the
recruitment issues relating to clinical trials in rare disease and are enjoyable and
professional to work with. They efficiently set up the complete process of patient community
involvement including the clinical trial website and everything was specific and tailored to
our needs.
We were very impressed with the number of interested and eligible patients going up
exponentially within short time. I would definitely recommend them to other companies
seeking this type of service.”
Sara Cazzaniga, Clinical R&D Manager
© admedicum® Business for Patients GmbH & Co KG 2021 19Company background & Geographical reach
Offices
Founded in 2015
admedicum Expert Partners
Extended Partner Network
Offices in: Cologne, Germany
Barcelona, Spain
Paris, France
Amsterdam, the Netherlands
Expert Partners in major European countries and
Partnerships with Patient Organizations to foster
Very deep understanding of the particular nuances of interactions with
patients; high credibility, strong credentials and networks
Excellent understanding of the significance of patient relevance in clinical
trials, regulatory, HTA and payer processes
© admedicum® Business for Patients GmbH & Co KG 2021 20Experienced leadership
Philipp von Gallwitz Dr. Andreas L.G. Reimann Dr. Roger J. Legtenberg
Managing Partner & Co-Founder Managing Partner & Co-Founder Senior Partner & Head of Benelux Region
Ø >25 years experience in healthcare Ø >20 years of clinical trial experience
Ø >20 years of leadership experience in
pharmaceutical industry Ø Social entrepreneur in the fields of Ø Passion for patient engagement and
patient-oriented health care and involved in implenting diverse (cross-
Ø Expert in legal compliance regarding
inclusive education. border) recruitment strategies for
industry-patient interactions
Ø Former CEO of German Cystic Fibrosis clinical trials
Ø Parent of daughter with CDKL5 (rare
Association; Former member of Board Ø Senior executive in Life Sciences (of
disease) and member of EU IMI Patient
of Directors EURORDIS – Rare Disease which 10 yrs leading a rare disease
Pool
Europe CRO, biotech & medtech companies
© admedicum® Business for Patients GmbH & Co KG 2021 21Our full portfolio of patient engagement & patient access services
Patient-focused product & service development
Patient
Stakeholder Engagement
Access
ADDED VALUE
Pricing & Reimbursement
Direct Patient Involvement in Clinical Trials
Patient Advocacy Liaison
Patient
Engagement
Structured Patient Dialogue
Patient Engagement Management
RESEARCH/ASSET -EVALUATION MARKET ACCESS &
& DEVELOPMENT COMMERCIALIZATION
© admedicum® Business for Patients GmbH & Co KG 2021 22CREATING VALUE
BY LINKING UP
INDUSTRY AND
PATIENTS
a d me d i cu m ® B u s i n e s s f o r P a ti e n ts Gmb H & C o KG
I n d u str i e str a ße 1 7 1 , 5 0 9 9 9 Kö l n
T e l . : + 4 9 -2 2 3 6 -9 4 7 3 3 -6 0 | F a x: + 4 9 -2 2 3 6 -9 4 7 3 3 -6 9
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