What are clinical trials Myths about clinical trials What patients want The role of patients in clinical trials How to communicate trial information How to communicate trial results

1. 1
The 2nd EORTC Cancer Clinical Research Methodology Course
for Patient Advocates – Brussels – March 4-5, 2016
The Role of Patients
& their Challenges in Clinical Trials
How to communicate “trial information & results”
to patients
Kathi Apostolidis
Vice President – European Cancer Patient Coalition
President – Hellenic Cancer Federation

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ECPC: "Nothing about us, without us"
• Members: 383 cancer patient organizations in 44
countries
• All cancers – common and rare
• Run and governed by patients
• Promoting timely access to prevention, screening,
early diagnosis, treatment & care for all cancer patients
• Reducing disparity and inequity across the EU
• Encouraging the advance of cancer research &
innovation & patient involvement in research
• Increasing cancer patients' influence over European
health and research policy

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European Cancer Patient Coalition’s Activities

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European Commission
• Joint Action on Cancer Control – CanCon
• Joint Action on Rare Cancers
• European Commission’s Expert Group on Cancer Control
• European Commission Initiative on Breast Cancer-Quality
Assurance Scheme Development Group (ECIBC/QASDG)
• Working Group on mHealth guidelines assessment
European Medicines Agency
• Patients’ and Consumers’ Working Party
ECPC: cancer patients’recognised voice

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What are clinical trials
Myths about clinical trials
What patients want
The role of patients in clinical trials
How to communicate trial
information
How to communicate trial results

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Questions clinical trials can answer
 Is a new treatment or combination safe? How
much?
 Is a new treatment effective?
 Is a new treatment better than or same to the
currently available treatments?
 Will all patients benefit? Or some will benefit
less?
 Are there biomarkers or other testing to
determine which patients will benefit most?

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Clinical Trial Design
Umbrella Trial -
lhttp://www.roche.com/media/store/roche_stories/as
co-2015-overview/asco-2015-story-2.htmla
www.institute-curie.org

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Myths about Clinical Trials
1st Myth: Clinical Trial as Last Resort
2nd Myth: Patients as Guinea pigs,
especially in Phase I
3rd Myth: Placebo
4th Myth: No stopping or Going Back

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Why patients enter Phase III trials
To do social good
Trust in his/her doctor
Favorable impression of the clinical research
associate
Lack of pressure to enter the trial
Sufficient information for decision making
Sufficient time to make decision
Favor for clinical trials
Expectation to do well
Support from family and friends
James R. Wright et al. 2004

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The Role of Patients in Clinical Trials
From research subject…
…to research partners…

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The Advanced Symptom Management System
(ASyMS)• Mobile phone-based
• Utilises an electronic
Patient-Reported Outcomes
(ePRO) measure, so ePRO
system
Sunday, 06 14
Patient completes ePRO
symptom questionnaire on
mobile phone on a daily basis
and whenever he/she feels
unwell
Data transferred to server and
subject to clinical risk algorithm
Alerts transmitted to
clinician’s handset
Evidence-
based self-
manageme
nt advice
Amber alert
(mild
symptoms)
Red alert
(severe or life-
threatening
symptoms)
E-Library
Symptom
graphs
Clinician logs onto website
to review alert
and contacts patient
Automated
message
prompts patient
to check self-
care advice
! !!
Real-time
Real-time Real-time
Real-time

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Trial results communication to patients
• Clinical trials results should be made available to
participants
• Providing results is the ethical standard
• Most patients want to know the results
• Women felt it should be their doctor who shares
the results
• Plan to share the results should be included in
the Informed Consent
• Guidelines needed for the optimum time to share
results
• Results should be shared before public disclosure

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Thank for your attention
Nothing about us without us!
email : kathi.apostolidis@ecpc.org
@cancereu
European Cancer Patient
Coalition
ECPCtv