the role of patients & their challenges in clinical trials
TRANSCRIPT
1The 2nd EORTC Cancer Clinical Research Methodology Course
for Patient Advocates – Brussels – March 4-5, 2016
The Role of Patients & their Challenges in
Clinical TrialsHow 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 trialsMyths about clinical trialsWhat patients want The role of patients in clinical trialsHow to communicate trial
informationHow 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/asco-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 Resort2nd Myth: Patients as Guinea pigs, especially in Phase I3rd Myth: Placebo4th Myth: No stopping or Going Back
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Why patients enter Phase III trials
To do social goodTrust in his/her doctorFavorable impression of the clinical research associateLack of pressure to enter the trialSufficient information for decision makingSufficient time to make decisionFavor for clinical trialsExpectation to do wellSupport from family and friendsJames 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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14 Monday 1 May 2023
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The Advanced Symptom Management System (ASyMS)• Mobile phone-based• Utilises an electronic
Patient-Reported Outcomes (ePRO) measure, so ePRO system
Patient completes ePROsymptom 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-
management 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 : [email protected]
@cancereu
European Cancer Patient Coalition
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