Clinical Trial Communication Opportunities v2 · help to increase overall engagement with clinical...
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of patients indicated that they would discuss clinical trial participation with their physician or HCP before contacting a clinical trial location • Informed consent form (ICF) • Government-sponsored clinical trial registries • Sponsors’ own trial websites • Information submitted to patient advocacy groups • Brochures/leaflets in clinical trial site settings • Publicly accessible educational resources on clinical research • Discussion(s) with treating physician on clinical research as a potential option What is the purpose of clinical trials and how do they work? What does it mean to participate in a clinical trial and what does the experience look like? What is the difference between placebo and standard of care? What questions should I ask my doctor? 56% Current Methods of Information Exchange Key Patient/Trial Participant Questions Opportunities to Improve Communication GATHER INFORMATION ABOUT CLINICAL RESEARCH Individual is in the healthcare system STAGE 1 The top two concerns before a trial begins are identifying who to contact/ medical center’s contact information and what to do in case of an emergency STAGE 2 CONSIDER CLINICAL TRIAL PARTICIPATION Individual considers and decides about specific trial participation • Evaluation of potential clinical trial options with treating physician and/or site staff • Multimedia informed consent What is the purpose of the trial? What will it measure? Who is overseeing the trial? How does the investigational product being tested work? How will the investigational product be given to me? What is expected of me during the trial? How will participation in this trial impact my daily life? What questions should I ask the clinical trial staff? (e.g., possibility of placebo, reimbursement of expenses) Will I be able to obtain my lab/test data during the trial? Key Patient/Trial Participant Questions Opportunities to Improve Communication • Informed consent form (ICF) • Government-sponsored clinical trial registries • Sponsors’ own trial websites • Information submitted to patient advocacy groups • Brochures/leaflets in clinical trial site settings Current Methods of Information Exchange 81% of patients said that knowing the potential risks and benefits of the study is important before considering participation STAGE 3 52% of patients want overall clinical trial statistics and a visit calendar or reminders PARTICIPATE IN A CLINICAL TRIAL Individual enters and participates in a trial • Discussions with site staff • Downloadable and hard copy trial guide and visit schedule • Updates on the status and progression of the overall trial • Invitation for patient to provide feedback on experience What should I do if something goes wrong? Whom can I contact for support? When is my next visit and what can I expect? What will the experience look and feel like? Are there opportunities for completing tests remotely or at a local lab? How is the trial progressing? Am I responding to the investigational product? When will my access to the investigational product end? Key Patient/Trial Participant Questions Current Methods of Information Exchange Opportunities to Improve Communication of patients want access to their own data/results want overall results of the clinical trial STAGE 4 83% 80% CONTINUE HEALTHCARE JOURNEY Individual has completed/ended participation in a trial • Invitation for patient to provide feedback on experience • Expression of gratitude from site to patient (on behalf of the sponsor) for contributions to research • Research alumni community What are my next steps? Are other trials available? Did I receive the investigational product during the trial? What was my response? Where is my lab/test data? What should I know before trying other treatments? What was the overall outcome of the trial? Will the investigational product be available on the market? When and what is its name? When and where can I find more information about the clinical trial results? How can I share my trial experience with others? Key Patient/Trial Participant Questions Current Methods of Information Exchange Opportunities to Improve Communication • Public disclosure of trial result after a trial ends as per regulatory requirements Read more about TransCelerate’s proposal to improve information exchange with patients throughout their clinical trial journey in a paper published in TIRS, Improving Information Exchange with Clinical Trial Participants: A Proposal for Industry. http://bit.ly/2AnH1qH Examining how best to meet patients’ information needs along the clinical trial continuum – from understanding if a clinical trial is appropriate for an individual to the process of enrolling and, finally, understanding the patient’s response to the trial – can help to increase overall engagement with clinical research and clinical trial participation. Researchers have an opportunity to consider improved ways of ensuring key patient questions get answered along this continuum. Clinical Trial Key Communication Opportunities for a Patient’s Clinical Trial Journey Gather information about clinical research STAGE 1 The Patient’s Clinical Trial Journey Consider clinical trial participation STAGE 2 Participate in a clinical trial STAGE 3 Continue healthcare journey STAGE 4 Statistics presented in this infographic originate from a global survey of patient and caregiver respondents. From the population surveyed, the majority of respondents had not previously participated in a clinical trial. Such respondents would have answered questions based on how they feel as potential study subjects, without necessarily having specialist knowledge regarding how clinical trials work. Copyright © 2017 TransCelerate BioPharma Inc. All Rights Reserved. COMMUNICATIONS OPPORTUNITIES
Transcript of Clinical Trial Communication Opportunities v2 · help to increase overall engagement with clinical...
of patients indicated that they would discuss clinical trial participation with their physician or HCP before contacting a clinical trial location
• Informed consent form (ICF)• Government-sponsored clinical trial registries• Sponsors’ own trial websites• Information submitted to patient advocacy groups• Brochures/leaflets in clinical trial site settings
• Publicly accessible educational resources on clinical research
• Discussion(s) with treating physician on clinical research as a potential option
What is the purpose of clinical trials and how do they work?What does it mean to participate in a clinical trial and what does the experience look like?What is the di�erence between placebo and standard of care?What questions should I ask my doctor?
56%
Current Methods of Information Exchange
Key Patient/Trial Participant Questions
Opportunities to Improve Communication
GATHER INFORMATION ABOUT CLINICAL RESEARCH Individual is in the healthcare system
STAGE 1
The top two concerns before a trial begins are identifying who to contact/ medical center’s contact information and what to do in case of an emergency
STAGE 2 CONSIDER CLINICAL TRIAL PARTICIPATIONIndividual considers and decides about specific trial participation
• Evaluation of potential clinical trial options with treating physician and/or site sta�
• Multimedia informed consent
What is the purpose of the trial? What will it measure?Who is overseeing the trial?How does the investigational product being tested work?How will the investigational product be given to me?What is expected of me during the trial?How will participation in this trial impact my daily life?What questions should I ask the clinical trial sta�? (e.g., possibility of placebo, reimbursement of expenses)Will I be able to obtain my lab/test data during the trial?
Key Patient/Trial Participant Questions
Opportunities to Improve Communication
• Informed consent form (ICF)• Government-sponsored clinical trial registries• Sponsors’ own trial websites• Information submitted to patient advocacy groups• Brochures/leaflets in clinical trial site settings
Current Methods of Information Exchange
81%of patients said that knowing the potential risks and benefits of the study is important before considering participation
STAGE 3
52%of patients want overall clinical trial statistics and a visit calendar or reminders
PARTICIPATE IN A CLINICAL TRIALIndividual enters and participates in a trial
• Discussions with site sta�
• Downloadable and hard copy trial guide and visit schedule• Updates on the status and progression of the overall trial• Invitation for patient to provide feedback on experience
What should I do if something goes wrong?Whom can I contact for support?When is my next visit and what can I expect? What will the experience look and feel like?Are there opportunities for completing tests remotely or at a local lab?How is the trial progressing?Am I responding to the investigational product?When will my access to the investigational product end?
Key Patient/Trial Participant Questions
Current Methods of Information Exchange
Opportunities to Improve Communication
of patients want access to their own data/results
want overall results of the clinical trial
STAGE 4
83% 80%
CONTINUE HEALTHCARE JOURNEYIndividual has completed/ended participation in a trial
• Invitation for patient to provide feedback on experience
• Expression of gratitude from site to patient (on behalf of the sponsor) for contributions to research
• Research alumni community
What are my next steps?Are other trials available?Did I receive the investigational product during the trial?What was my response?Where is my lab/test data?What should I know before trying other treatments?What was the overall outcome of the trial?Will the investigational product be available on the market?When and what is its name?When and where can I find more information about the clinical trial results?How can I share my trial experience with others?
Key Patient/Trial Participant Questions
Current Methods of Information Exchange
Opportunities to Improve Communication
• Public disclosure of trial result after a trial ends as per regulatory requirements
Read more about TransCelerate’s proposal to improve information exchange with patients throughout their clinical trial journey in a paper published in TIRS, Improving Information
Exchange with Clinical Trial Participants: A Proposal for Industry.http://bit.ly/2AnH1qH
Examining how best to meet patients’ information needs along the clinical trial continuum – from understanding if a clinical trial is appropriate for an individual to the process of enrolling and, finally, understanding the patient’s response to the trial – can
help to increase overall engagement with clinical research and clinical trial participation. Researchers have an opportunity to consider improved ways of ensuring
key patient questions get answered along this continuum.
Clinical Trial
Key Communication Opportunities for a Patient’s Clinical Trial Journey
Gather information about clinical research
STAGE 1
The Patient’s Clinical Trial Journey
Consider clinical trial participation
STAGE 2Participate in a clinical trial
STAGE 3Continue healthcare journey
STAGE 4
Statistics presented in this infographic originate from a global survey of patient and caregiver respondents. From the population surveyed, the majority of respondents had not previously participated in a clinical trial. Such respondents would have answered questions based on how they feel as potential study subjects, without necessarily having specialist knowledge regarding how clinical trials work.
Copyright © 2017 TransCelerate BioPharma Inc. All Rights Reserved.
COMMUNICATIONS OPPORTUNITIES
