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Trial Patient and Site Engagement Playbook – co-created with patients and clinical trial sites, the Trial Patient and
Site Engagement Playbook provides the roadmap for patient & site engagement initiatives that will ensure the
voice of our customer is elevated and incorporated into the way in which we development of medicines


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Vision Statement:
This playbook was designed with insight from real patient and site experiences globally with the intention to elevate the patient voice in end to end clinical development.
To ensure successful patient engagement, we encourage teams to collaborate cross-functionally across BI and co-create with patients and organisations as early as possible, across all stages of development.
This will ensure greater inclusion of the  patient and customer voice, adoption and engagement of co-created content to position BI as a preferred partner of choice. This playbook is continually evolving and will become more complete over time.
Vision Statement:

This playbook was designed with insight from real patient and site experiences globally with the intention to elevate the patient voice in end to end clinical development.

To ensure successful patient engagement, we encourage teams to collaborate cross-functionally across BI and co-create with patients and organisations as early as possible, across all stages of development.

This will ensure greater inclusion of the  patient and customer voice, adoption and engagement of co-created content to position BI as a preferred partner of choice. This playbook is continually evolving and will become more complete over time.
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Positive Experience
Excitement, positivity and hope around the potential of a new treatment option which is largely generated by HCPs (more pronounced in oncology)
Low awareness in general public, concerns around being a ‘guinea pig’ & system/process feel mysterious and even taboo
CT awareness and enrolment is mostly HCP driven (in CT naïve) as patients are hesitant towards CTs – considering only when ‘running out’ of options
Patients will supplement their knowledge and understanding with a second opinion or seek online resources for more information
An underlying sentiment that trials have been designed around the science and data - but not the patient (e.g. when inconsistent monitoring occurs)
Initial awareness & understanding of clinical trials is low, fear of receiving placebo, safety concerns
Often have to be encouraged to learn more (unless previous CT experience), however trial info materials can be hard to find / understand / don’t give the right info
HCPs are not always knowledgeable about trials so initial conversations can leave patients requiring additional support & information
Limited involvement in design stage – yet desire for a site & patient centric focus
Can BI help to raise CT awareness generally and dispel any myths – or focus on true positives e.g. access to high quality care?
Disconnect between initial interest of CTs vs. experienced patients desperate for another CT – can BI leverage this gap?
Patients could be better supported in their initial understanding of CTs – how can BI offer early stage support?
Getting representation from the patient or key sites could improve the overall design process
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Positive Experience
Involvement in trials is seen as being at the forefront of improving patient outcomes whilst also increasing physician credibility and notoriety.
An underlying sentiment that trials have been designed around the science and data - but not the patient (e.g. when inconsistent monitoring occurs)
Some frustrations when CROs respond slowly, don’t have the expertise or have high turnover
Ethics committee approval is seen as non-standardised, which often creates extra work and considerable delays = frustrations for the site
Limited involvement in design stage – yet desire for a site & patient centric focus
Minimal relationship with sponsors – somewhat bridged by CRO, but need for pharma support
Ethics committee approval is not consistent between trials
Getting representation from the patient or key sites could improve the overall design process
A highly accessible, knowledgeable and consistent contact whether pharma co or CRO can have a significant impact on experience
Ensuring consistency either within BI or in partnership with other sponsors could remove some frustrations
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Positive Experience
Patients appreciate the opportunity to access potential new treatment and help future generations
Mixed feelings about starting – generally content with initial steps, but only later fully realise the seriousness of potential side effects when they start treatment
Patients are presented with many pages of information to review, often written in technical language and filling out many forms is demanding.
Less likely to fully understand the potential risks or impact of AEs
Excessive paperwork (informed consent) is overwhelming
Is there a way to provide simpler ways of communicating to supplement the detail – such as videos and patient friendly language summaries?
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Positive Experience
There is a team approach to recruitment, with HCPs appreciating referrals from colleagues and building strong relationships between the trial team and the patients from the outset
A significant pain point – HCPs question the need for some criteria that is too strict and inflexible – this can result in HCPs being ultra selective in the patients they approach
Frustration among both HCPs and patients. HCPs find that setting up a trial is exhausting, balancing patient support vs. paperwork.
HCPs have so much to cover with limited time – everything is discussed but not in high detail for patients to truly understand
Frustrations around inflexibility & strictness of criteria
The screening process (and esp. the excessive paperwork) is a time burden
Limited time to fully explain process
Increasing awareness of tactics and tools that can support the recruitment process will decrease the pressure on sites
Click to access the Digital Handbook for Clinical Trial Recruitment
Any way to streamline the burden of screening patients will improve the experience of both site and patient
Allocating more time and space to early conversations can minimise stress for HCPs and overwhelming patients
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Positive Experience
As part of a trial, patients perceive their level of care to be much higher and describe themselves as being treated like “royals” and “VIPs”.
Patients are unsure what to report (mirrored by HCPs) and can lead to worry if they withhold from reporting, or share too much
High anxiety in the first 1-2 weeks, as patients wait to see if they experience any adverse effects.
Whilst trial retention is not affected, some patients esp. frailer can miss some appointments, and monitoring can be burdensome
Initial lack of confidence around reporting ‘correct’ AEs
Initial period of anxiety about ‘unknowns’ of response to treatment
Patients can miss some appointments and may even drop out if the trial impacts life more than they can handle
Giving patients the confidence around what to look out for could reduce anxiety for both HCP and patients
Managing the process from an early stage can help patients mitigate any major concerns they have prior to starting the treatment
Ensuring the design and protocols are conscious of the impact logistically on patients can minimise burden
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Positive Experience
The high quality of care and strong patient relationships mean most don’t see trial retention as an issue. Investigators and coordinators feel that as long as the patient is well-informed, most want to stay in the trial and are grateful to take part.
Practical challenges and emotional stresses for the site team – worry of patients not appropriately reporting AEs, and can be uncertain around dose management
Practical challenges of AE monitoring causes HCP worry/concern
Incorporating digital initiatives as part of the data collection process can support AE monitoring
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Positive Experience
Emotional payoff for patients who feel they have contributed towards a ‘higher purpose’ and supported others in the future with the same condition.
Patients are sad to end the trial. It means the end of high quality care, monitoring – and some had made close relationships with nurses and other participants
Few patients were offered the results, or followed up with the publication. There was a desire to see how other patients did on the trial
Emotionally difficult to move away from high care and an effective treatment
Rare to be offered trial outcomes – despite a desire for this
A process that helps the site manage the end to the trial will help HCPs and patients prepare for life afterwards
Offering patients a chance to see the results is extremely meaningful
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Positive Experience
HCPs feel like they have been part of a process that is emotionally rewarding (if patients have benefitted from treatment) whilst also supporting their personal development (gaining experience with new treatments) whilst also contributing to science.
Closing conversations can be difficult emotionally for HCPs, and some try to help by offering replacement treatments, other CTs or applying for compassionate use
If not clearly signposted, data cleaning at the end of the trial process can create a “mad dash” to get the information ready for sponsors
Little to no information is provided to both HCPs and patients after they finish the clinical trial, and HCPs feel the need to be recognised in these outcomes
Challenging to manage patients off a clinical trial – esp. if abrupt closure
Limited notice on submission deadlines can put teams under pressure
Rare to be offered trial outcomes & experience little recognition
A process that helps the site manage the end to the trial will help HCPs and patients prepare for life afterwards
Ensuring submission deadlines are planned for as far in advance as possible takes pressure off the site
Sharing publications with HCPs is important, and can be part of a wider recognition for their efforts
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Summary of Experience: Patients
Low awareness in general public, concerns around being a ‘guinea pig’ & system/process feel mysterious and even taboo
CT awareness and enrolment is mostly HCP driven (in CT naïve) as patients are hesitant towards CTs – considering only when ‘running out’ of options
Patients will supplement their knowledge and understanding with a second opinion or seek online resources for more
Mixed feelings about starting – generally content with initial steps, but only later fully realise the seriousness of potential side effects when they start treatment
Patients are presented with many pages of information to review, often written in technical language and filling out many forms is demanding
Patients are unsure what to report (mirrored by HCPs) and can lead to worry if they withhold from reporting, or share too much
High anxiety in the first 1-2 weeks, as patients wait to see if they experience any adverse effects
Whilst trial retention is not affected, some patients esp. frailer can miss some appointments, and monitoring can be burdensome
Patients are sad to end the trial. It means the end of high quality care, monitoring – and some had made close relationships with nurses and other participants
Few patients were offered the results, or followed up with the publication. There was a desire to see how other patients did on the trial
Summary of Experience: Patients
Low awareness in general public, concerns around being a ‘guinea pig’ & system/process feel mysterious and even taboo
CT awareness and enrolment is mostly HCP driven (in CT naïve) as patients are hesitant towards CTs – considering only when ‘running out’ of options
Patients will supplement their knowledge and understanding with a second opinion or seek online resources for more
Mixed feelings about starting – generally content with initial steps, but only later fully realise the seriousness of potential side effects when they start treatment
Patients are presented with many pages of information to review, often written in technical language and filling out many forms is demanding
Patients are unsure what to report (mirrored by HCPs) and can lead to worry if they withhold from reporting, or share too much
High anxiety in the first 1-2 weeks, as patients wait to see if they experience any adverse effects
Whilst trial retention is not affected, some patients esp. frailer can miss some appointments, and monitoring can be burdensome
Patients are sad to end the trial. It means the end of high quality care, monitoring – and some had made close relationships with nurses and other participants
Few patients were offered the results, or followed up with the publication. There was a desire to see how other patients did on the trial
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Summary of Experience: Clinical Trial Site
An underlying sentiment that trials have been designed around the science and data - but not the patient (e.g. when inconsistent monitoring occurs)
Some frustrations when CROs respond slowly, don’t have the expertise or have high turnover
Ethics committee approval is seen as non-standardised, which often creates extra work and considerable delays = frustrations for the site
A significant pain point – HCPs question the need for some criteria that is too strict and inflexible...
Frustration among both HCPs and patients. HCPs find that setting up a trial is exhausting, balancing patient support vs. paperwork
HCPs have so much to cover with limited time – everything is discussed but not in high detail for patients to truly understand
Practical challenges and emotional stresses for the site team – worry of patients not appropriately reporting AEs, and can be uncertain around dose management
Closing conversations can be difficult emotionally for HCPs, and some try to help by offering replacement treatments...
If not clearly signposted, data cleaning at the end of the trial process can create a “mad dash” to get the information ready for sponsors
Little to no information is provided to both HCPs and patients after they finish the clinical trial...
Summary of Experience: Clinical Trial Site
An underlying sentiment that trials have been designed around the science and data - but not the patient (e.g. when inconsistent monitoring occurs)
Some frustrations when CROs respond slowly, don’t have the expertise or have high turnover
Ethics committee approval is seen as non-standardised, which often creates extra work and considerable delays = frustrations for the site
A significant pain point – HCPs question the need for some criteria that is too strict and inflexible – this can result in HCPs being ultra selective in the patients they approach
Frustration among both HCPs and patients. HCPs find that setting up a trial is exhausting, balancing patient support vs. paperwork
HCPs have so much to cover with limited time – everything is discussed but not in high detail for patients to truly understand
Practical challenges and emotional stresses for the site team – worry of patients not appropriately reporting AEs, and can be uncertain around dose management
Closing conversations can be difficult emotionally for HCPs, and some try to help by offering replacement treatments, other CTs or applying for compassionate use
If not clearly signposted, data cleaning at the end of the trial process can create a “mad dash” to get the information ready for sponsors
Little to no information is provided to both HCPs and patients after they finish the clinical trial...
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Index
Early planning of the trial
Starting the trial
During the trial
Finishing the trial +
Case Studies
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Initial steps and setting up / Becoming aware
Perspective
Patient
Patient
Site
Site
Site
Site
Site
Topic
Clinical trial awareness
Next steps after learning about the trial
Reasons for involvement
Trial and protocol design
Ethics committee approval
KO meetings
DCTs, digitalisation and innovations within clinical trials
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Starting the trial
Perspective
Site
Site
Patient & Site
Patient
Patient & Site
Site
Topic
The recruitment process
Screening and inclusion criteria
Capturing informed consent
Reasons for enrolment
Initial conversations around clinical trials
Connecting clinical trial investigators and patient treating physicians
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During the trial
Perspective
Patient & Site
Site
Patient & Site
Patient
Site
Patient
Topic
Trial retention
Trial retention and patient monitoring
Adverse events
In trial care – patient questions
Relationships with the CRO
Patient empowerment
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Finishing the trial
Perspective
Site
Patient & Site
Patient & Site
Patient
Site
Topic
Data cleaning
Feelings at the end of the trial & closing conversations
Communication of results
Follow-up
Feelings post-trial
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Case Study Topics
Topic
Early Planning of the Trial – Representation of Patients & Sites in Trial Design
Early Planning of the Trial – Diversity, Equity & Inclusion
Initial Steps & Setting Up – Awareness and Education
Starting the Trial – Informed Consent
During the Trial – Minimise Burden
During the Trial – Patient Surveys / Trial Experience Surveys
Finishing the Trial – Sharing Results
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