Patient engagement is vital for successful clinical trials – from recruitment all the way to completion. In our recent mdWebinar series, many of our panellists highlighted the need to improve patient engagement at every stage of the clinical journey and why it matters.
From increasing awareness of opportunities to take part in studies, through to treating patients as stakeholders in trial design, there are multiple opportunities for the industry to engage more effectively with patients at every touchpoint. As decentralised or fully virtual trials become more common, and with technologies replacing much in-person communication and home healthcare replacing site visits, effective patient engagement is more vital than ever.
In this in-depth guide, we look at all aspects of patient engagement across the entire clinical trial journey, and why it’s important in ensuring diversity amongst participants and looking after patients’ mental wellbeing. We also look at why effective communication is vital in delivering a remarkable patient experience, and how to communicate with patients in a way that keeps them engaged throughout the process.
Raising Public Awareness of Clinical Trials
Research has shown more than 75% of the general public are willing to participate in clinical trial studies. If this is the case, why do so many studies still struggle to meet their enrollment targets?
More effective engagement with eligible patient and volunteer populations is needed.
Lack of clinical trial awareness is one of the biggest barriers to engagement globally. Most people aren’t aware of what clinical trials involve, why they’re important, or how they can contribute. Most patients don’t realise they are eligible to participate in trials, or where to find out about opportunities to enrol.
If patients don’t fully understand what clinical trials involve or the benefit of taking part, why would they engage with the industry? A few key ways we can improve engagement with clinical trials amongst the wider public and patient populations are:
- Using plain language in clinical trial literature which speaks directly to a patient’s needs, addresses their concerns, clearly outlines study goals, and is transparent about risks and commitments
- Sharing information with healthcare practitioners and media in a way that’s straightforward and jargon-free, ensuring information about specific clinical trials is clear and accurate
- Encouraging patient and volunteer advocacy by asking trial participants to share their experiences via social media, online patient forums, or word of mouth
Raising awareness and knowledge of clinical trials amongst Health Care Practitioners (HCPs) is also an essential part of the picture. Few patients are informed by their doctors or consultants of clinical research studies they might be eligible for, simply because the majority of HCPs don’t have this knowledge.
Furthermore, most patients aren’t aware that clinical trial participation can be an accessible and viable treatment option. If we work on raising awareness of these options, we will improve both public engagement with and perception of the industry.
Raising awareness of clinical trials and ensuring public engagement is more important than ever. Our goal should be for studies to be viewed favourably by patients around the world. They should be seen as a way of accessing exceptional healthcare and ongoing monitoring – especially as usual healthcare routes might be experiencing delays, cancellations, or less regular reviews for a significant while post-COVID.
Addressing Barriers to Clinical Trial Accessibility
Raising awareness amongst the public and within patient communities is only the first step in increasing patient engagement with clinical trials. The crucial next step is to address barriers to accessibility, which will take a collective commitment from us as an industry.
As we work to engage more patients and volunteers, we must simultaneously work to break down socioeconomic, geographic and financial barriers that limit the ability to participate.
The biggest barriers to clinical trial participation currently are:
- Geography – more than half of patients don’t have access to clinical trials at their local treatment centres, meaning most have to travel long distances to a specific institution to participate.
- Finance – clinical trial participation comes with associated costs and time commitments. As a global recession looms post-COVID, and more people are worried about finding jobs or requesting time off from work, financial barriers to clinical trial participation will only increase.
- Education – if patients and volunteers simply don’t know about clinical trials, they don’t have any opportunity to engage at all.
To overcome these barriers, we need:
- Decentralisation of trials – clinical research can be brought to specialists in smaller, local institutions. Where an appropriate local trial is not available, travel could be minimised by introducing home visits to replace some site visits.
- Reducing financial burden – some site visits can be replaced with home visits to reduce upfront travel costs. Where costs are incurred by participants, processes must be in place and technologies used to ensure swift reimbursement.
- Promote better health literacy – education can be provided through public events, awareness campaigns, as well as providing resources to allow for participants to educate themselves. This includes education around particular diseases and how the clinical industry is working to improve treatment.
Patients are more likely to engage with and enrol in clinical trials when they are well-informed and can see an effort on the part of the study organisers to reduce potential barriers and make participation as easy as possible through models including decentralisation, home healthcare, and use of technology.
Improving Diversity in Clinical Trial Participants
Historically, a key issue in patient engagement has been a failure to engage diverse patient populations. As a result, people of white, European descent are over-represented in clinical trial participation. They’re also less likely to be stopped by the barriers outlined above.
The key problem this presents to the clinical industry is that a less diverse participation base to work with can impact the advancement of health research, as treatments may be developed without being tested on people from different genders or ethnic backgrounds.
This makes engagement with, and recruitment from, diverse populations essential for research organisations to make progress that benefits everyone.
To make clinical research more diverse, we need to:
- Engage with minority communities – bringing clinical trial knowledge and expertise into the places minority people are seeking care. Armed with this knowledge, primary care physicians and consultants can have conversations with eligible patients and make recommendations of clinical trials which are accessible and beneficial to them.
- Increase diversity amongst researchers – patients are more likely to trust and participate in clinical research when they can relate to those involved with the studies
- Invest in targeted outreach – CROs and sponsors should co-create clinical trial communications with patient groups and minority communities, and work together on outreach programmes.
Engaging diverse populations is vital for progression. Differences in age, gender, and racial background can lead to different effects from the same treatment, and some groups may experience completely different results from the majority.
For clinical studies to be truly patient-centric and for drug development to be effective for the highest number of patients, diversity must be a key focus. And that starts with engagement.
Looking After Patient Mental Health
Mental health has been brought to the forefront of many peoples’ minds in 2020 – and the clinical industry is no exception. As patients generally express more anxiety around clinical trial processes – especially those who are more vulnerable or at risk – it has been vital that we engage in these conversations with patients.
The demands of a clinical trial may be too much for some patients to deal with, especially dealing with complex or rare diseases. For example, stressful travel and intrusive assessments are key reasons patients cite for dropping out of clinical trials – therefore, we can ask where these might be replaced by home health visits or technology-based solutions.
As well as leading to disengagement and impacting retention, poor mental health can also impact on reported side effects which might affect the outcome of a drug trial.
Opening up conversations with participants and engaging with them around their mental health will increase our understanding of the links between mental health and clinical trial impact. It should be best practice to conduct a ‘mental health impact assessment’ on each element of the trial, attempt to reduce potential negative impact wherever possible, and record and assess behavioural changes as the study progresses.
By understanding external triggers for mental health issues, extending compassion towards participants suffering from mental health problems, and looking at where negative mental health impact can be mitigated CROs will see a positive effect on participant attraction and retention in clinical trials. Furthermore, including patients who are more diverse in terms of mental health will reflect positively on trial outcomes overall for the same reasons as age, gender, and racial diversity.
If our collective processes for recognising and looking after patient mental health were more robust and effective, we wouldn’t need to exclude patients with known mental health issues from participating in clinical trials. Instead, if we can accommodate mental illness, we can develop research that not only takes care of its participants but also results in drugs that have more effective real-world application.
Involving Patients in Clinical Trial Design
We know the most common reasons patients cite for dropping out of clinical trials. The question is, how many of these issues might have been avoided if patients had more input in informing the end to end design? And what better way to ensure patient engagement than when patients have had input into study processes and protocols?
According to the UK’s National Institute of Health Research, involving patients in the clinical development process has the potential to significantly improve study design and delivery, resulting in better recruitment, retention, and engagement throughout – including protocol adherence.
To effectively engage patients in clinical trial design, CROs and sponsors will need to work closely with patient advocacy groups and informed patients. When these groups are brought in as consultants and partners, study organisers can better understand and address patient concerns and are better equipped to support them through the clinical journey.
However, the right patient groups must be involved at the right stages. There will be times when it’s necessary to speak to ‘expert’ patients and highly informed advocacy groups, and times when it’s vital to speak to patients who don’t have as much knowledge of their condition, general health literacy, or advocacy experience.
Broadly, patients fall into three groups as potential consultants*:
- Patients by experience who can offer feedback on elements of the trial process such as travel and logistics which have a direct impact on their lives
- Expert patients who know a lot about the wider patient community, and can anticipate other patients’ needs and share anecdotal advice from theirs and others’ experiences
- Pro patients who know different patient communities, are aware of issues affecting the healthcare system and can offer advice on the entire journey from recruitment through to completion
*From Patient Experience Pyramid – Copyright Trishna Bharadia.
Consulting with patients on the clinical trial journey is all well and good – but then study designers must ensure patient input is integrated into trial design.
To bridge the disconnect between gathering patient input and putting it into action, sponsors and CROs must be willing to increase their budgets for a longer-term gain. For example, they may need to commit to creating more formal patient-led roles within their teams, ensure the consultancy process allows for additional rounds of feedback to fully translate patient input into the trial endpoints, or invest in necessary technologies and home health solutions to introduce virtual trial elements that reduce patient burden such as travel and up-front costs.
Communicating with Patients Effectively
Effective communication is essential for patient engagement and retention during a clinical trial – especially as more trials are moving to virtual or decentralised models where face to face contact with patients is limited.
While patient safety has always been paramount when it comes to clinical trial design, effective communication and the overall patient experience hasn’t historically been prioritised in the same way. Now, this has to change.
Confusion around processes and protocols is a key reason patients drop out of a study, meaning poor communication can cost sponsors in lost time and revenue as well as jeopardising trust between study organisers and patients.
The core principles of exceptional patient communication are:
- Minimising jargon – avoid clinical terms and always use the simplest explanation of any process or procedure. If the patient wants more in-depth or complex information, make it clear that they can request this.
- Being specific – provide clear, step-by-step instructions for every process and always specify exactly what will be involved and what’s expected of the patient.
- Using repetition – repetition helps reinforce key information. Ensure that core messages are highlighted and stated more than once.
- Checking patient understanding – when you’ve explained something or provided information, check-in with patients. Perhaps ask them to repeat back what they understood, sit with them as they walk through the process, and ensure they have a contact who is available for them 24/7 during their participation should they run into any issues.
- Leveraging technology effectively – from video calling to automated SMS reminders to dedicated apps for sharing essential information and facilitating regular check-ins. In order to work as an enabler rather than a barrier, technology must be intuitive, integrate into patients’ existing lives and routines, be reliable, and be easy to use.
Above all, patients want to be treated as investors in clinical trials, not as guinea pigs. CROs must ensure processes are in place to check-in consistently with patients, creating a feedback loop that addresses and issues or concerns as they arise.
Key points in the patient journey where communication matters most are:
- Explaining processes in depth while onboarding, including additional or unfamiliar measures that may be in place for decentralised trials.
- Checking in with patients at regular intervals to offer a space for questions, explicitly enquire about any issues, and make them aware of additional support.
- Showing appreciation at the end of the trial – acknowledge the role patients have played in their trial, thank them for it, and ensure they know they’re appreciated.
- Sharing results – patients are investors. Keep participants updated on the outcome of the study, so that they can see the difference they have made.
True patient-centricity means patients feel involved, heard and appreciated for their role in the clinical journey. Expecting patients to simply follow processes and be subject to procedures they don’t fully understand isn’t enough. Patients expect better – and that starts with communication.
Patient engagement is vital for clinical trial success, impacting everything from recruitment to advocacy. To recruit more diverse patients, a wider pool of patients needs to be engaged in clinical research as a concept – which means more public education drives are needed.
Engagement with a wider population isn’t enough though. We need to actively address barriers to participation from a geographical and socio-economic perspective, as well as ensuring clinical trial protocols put patient wellbeing at the forefront and don’t exclude participants who believe the toll on their mental wellbeing would be too much. The increasing movement towards decentralised trial models is going some way towards addressing many of these barriers.
Patients must have their mental health looked after throughout the clinical journey in order to engage fully with trial protocols and not drop out, and there needs to be a deeper understanding and willingness as an industry to engage patients with existing mental health conditions.
Patients will also be more engaged with a clinical trial when they and their communities have been actively consulted from the beginning as co-creators and stakeholders. In seeing their opinion listened to and translated into action, they’ll feel like investors rather than guinea pigs.
Above all, effective communication end to end is vital in ensuring patients are engaged – and this is especially important when face to face contact is reduced or eliminated in the case of decentralised or fully virtual trials, where technologies replace real life interactions in many scenarios. Good communication underpins the entire patient journey, reducing the chance of dropouts and increasing the chance of patients becoming active advocates for trial participation in future.
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