Everything you need to know about patient engagement in clinical trials
What does patient engagement mean to you? Getting feedback from patients about your clinical trial, or maybe making sure they’re motivated to take part? Officially, patient engagement is defined as the process of building the capacity of patients, families, carers and healthcare providers to facilitate and support the active involvement of patients in their own care, in order to enhance safety, quality and people-centredness. Patient engagement, which is not the same as patient experience, has been a topic of interest in clinical trials for some time, but there is still a long way to go.
As organisations in the pharmaceutical and healthcare industries strive to meet short term business goals, arguably the most important people involved in clinical trials, the participants, are often overlooked. And we know that this doesn’t go unnoticed. It is continually fuelling the negative perception of clinical trials by the public, including patients. One study captured the experiences of over 3,600 study volunteers and found that 96% would be willing to participate in another study. However, previous research demonstrated that general willingness to participate was lower among those who had not taken part in a study before (59% of clinical trial participants vs 25%).
So, what is influencing this willingness? There are numerous factors that influence whether someone wants to take part in clinical trials and their experience when they do, including:
Recommendation of healthcare professional
Previous healthcare experiences
If the opportunity is presented, and how the study is communicated
Study treatment deemed as the ‘better’ option versus standard of care
Convenience of travel to study site
Cost of travel (and reimbursement)
Number of appointments and time required
Overall duration of study
To thrive in patient engagement in clinical trials, you have to recognise that there’s no one size fits all approach. The significance of the factors listed above varies on an individual basis and people have different personal motivations for choosing to take part in a study. Even after the enrolment stage, each person has a unique set of preferences and needs; the extent to which these needs are met contributes to the entire patient experience. Engaging with patients before, during and after clinical trials can prove invaluable and help to shape recruitment and retention strategies. Implementing the right strategy and using effective tools can be the difference between meeting targets and deadlines and ultimately, study success and failure.
The importance of patient engagement in clinical trials
It has been estimated that approximately 70–90% of clinical trials fail to meet recruitment targets and some studies even close because of patient recruitment challenges. Perhaps this is an unwelcome truth for your study too. Further to this, once studies have successfully recruited patients, it is not uncommon for people to choose to stop taking part. With these patient recruitment and retention issues in mind, it is logical to consider that the issue may surround engagement with those at the very heart of clinical trials: patients.
The involvement of patients, carers and their networks in decisions about a clinical trial can contribute to its success. By gaining key insights and optimising the patient experience:
Patients are more likely to want to join the clinical trial
Patients are more likely to continue taking part
Patients and their network are engaged with the clinical trial
Patients have a greater understanding of their care and contributions to research
Patients feel valued and at the centre of the clinical trial (rather than financial outcomes).
To achieve these outcomes, it is crucial to effectively engage with patients throughout clinical trials, from the planning stages until after the study has ended. Firstly, you need to consider the patient journey, which is outlined in Figure 1.
Figure 1. Overview of the patient journey.
Currently, many clinical trials are already deterring patients based on decisions made on the early stages, such as during planning and design. But you can do things differently. Patients will be more likely to want to and be able to take part in a study if their voice has been considered in the planning stages. Engaging with patients early on can have a huge impact further down the line.
Patients need to be made to feel valued and supported from recruitment to when their time on the study ends. All aspects of your study (including the patient recruitment strategy) should be designed with patients at the centre. Carers, friends and family of patients may also routinely attend patient’s appointments and want to have a good understanding of the study and exactly what is involved. Therefore, it is essential that their needs are considered alongside the patients. If study participation is a negative experience for patients and/or carers, patients will be more likely to not adhere to treatment, miss appointments and drop out of the study. This will negatively impact the study data and ability to meet targets and endpoints, alongside worsening the reputation of clinical trials. Patient engagement is crucial for diversity and inclusion too. Your study needs to be culturally safe, from interactions with study staff, to recruitment materials.
The organisations responsible for conducting clinical trials have a duty to inform patients of progress at all stages from recruitment to the study finishing, irrespective of how long the patient takes part for. But do you know how people would like to receive that information and in what detail? Research shows that people want to be informed on study results and findings and would appreciate more detailed information. In 2013, updates were made to the Declaration of Helsinki to state that patients should have the option to receive information about the overall results of the study. Although this was a step in the right direction, information is not always being shared in an effective way. By conducting patient research, you can make informed decisions on how and when information should be shared, and increase patient centricity.
Overall, patient engagement is an instrumental element in clinical trials that is vital for achieving patient centricity but also helps to determine if a study starts on time, meets recruitment targets, finishes on time, and produces robust, high quality data.
How to engage with patients
It is evident that there are abundant opportunities for you to engage with patients and their networks throughout the patient journey. Various methods can be used to engage patients and obtain key insight, and each brings its own set of benefits. Every method outlined here ensures that patients and carers remain central. Understanding what patients truly want, need and feel provides rationale for decision-making regarding study design and strategy rather than reliance on assumptions.
Quantitative and qualitative surveys provide data that can inform the design of clinical trials and recruitment and retention strategies. Questions can be focussed on any of the different areas of study design, such as the schedule of assessments or eligibility criteria. Surveys can also be accompanied by specific materials (such as an informed consent form or patient information sheet) to see how well patients understand the information, as well as to gather their opinions on them. Surveys can also be conducted during and after a clinical trial to obtain feedback on the patient experience and overall process.
Interviews reveal more in-depth and detailed opinions compared with surveys. Interviews can be conducted with patients to increase understanding of a condition and what matters most to patients. Interviews are also a great tool to hear about the opinions of specific groups (e.g. ethnic minority groups) to see if any groups face additional barriers in clinical trials compared with others. During clinical trials, interviews are an opportunity to gain patient feedback on how their expectations are being met. If the logistics of a face-to-face interview are challenging, phone or online video meetings are a suitable alternative.
To gather information from different patients simultaneously, focus groups are a useful method. They allow for discussions and debates between patients about their condition or a clinical trial. Focus groups can be particularly interesting if a diverse group is brought together, so that you can hear potentially opposing opinions from all. Moderators can probe differing perspectives within these groups.
Patient and caregiver advisory boards
By organising advisory boards where patients and carers can input, you can gain vital insights that inform recruitment and retention strategies. Advisory boards are advantageous because they are a structured way of obtaining qualitative feedback over a longer period of time than an interview. In addition, materials and information can be presented to multiple patients at one time. Advisory boards are also an opportunity to educate people on a specific study or clinical trials in general. The result is that patients and carers will become more engaged with research and provide feedback that improves the patient experience for others, in turn positively impacting recruitment and retention rates. Virtual advisory boards offer the benefits of reduced costs and the ability to involve participants where geography or travel is an issue.
Patient and caregiver input workshops (co-design)
Co-designing workshops with patients and carers is a powerful approach that has various benefits, such as ensuring that workshops are run in a way that best meets the specific group’s needs. A collaborative approach can ultimately result in improved efficiencies and more representative outcomes, increased patient satisfaction and trust, and greater capacity for medical research. Such workshops can help with user testing and co-creating patient recruitment materials.
Patient journey mapping
As mentioned, recognising that each participant in a clinical trial has their own journey can have a huge influence on their experience during the study, and consequently how likely they are to continue taking part. Mapping the patient journey helps to understand patients’ expectations, helps support patients, and enables you to improve the clinical trial process to suit the patient’s specific journey.
Patient persona mapping
Persona mapping in clinical trials means getting to know more about the overall patient profile. Fully understanding individual patients can help improve the patient experience and maximise patient recruitment and retention. Completing patient persona templates provides information such as basic demographics and health-related, psychographic and ethnographic factors. This knowledge can support the development of recruitment and retention strategies, and allows you to better understand your target patient.
Social media listening
Social media listening utilises online conversations to gain valuable insights on people’s opinions about conditions, treatment options and research. Social media listening gives you a detailed analysis of patient groups, showing what they care about and where they discuss things on social media. A key benefit of social listening is that the data is pre-existing and not influenced by any research biases. Patients are freely expressing themselves online without any prompt or question. This data can be used to inform your patient recruitment strategy, making it tailored to your target patient population.
Ethnography is the study of social interactions, behaviours, and perceptions that occur within groups, teams, organisations, and communities. Mobile ethnography has become an increasingly popular way to understand a specific patient population. Instead of living within a community over an extended period (as traditional ethnographers would do), you are able to create private groups online to analyse group behaviour through assigning virtual tasks. This method can be used to set direction in early clinical development by providing a rich collection of information, which helps to determine endpoints for future research. Health behaviours and differences in healthcare delivery cannot necessarily be detected using quantitative methods, so mobile ethnography is a good alternative to better understand patients and healthcare delivery teams.
User testing has never been more important for healthcare organisations. Without receiving feedback from patients on different clinical trial materials, we cannot know whether the materials created are appropriate and effective in recruiting and retaining a specific patient group. User testing allows patients to assess if digital platforms or websites are optimal to use (from a design and navigation point of view). Patient can also test printed materials to assess how appropriate they are. This approach will save time and money later down the line for a clinical trial as you can identify and overcome issues early on.
Recommendations from patient research
By gaining insights from patient research recommendations can be made that eventually positively impact patient recruitment and retention.
Aspect of clinical trial
General study design
Understand how patients are impacted by their disease away from a hospital setting
Identification of unmet needs and potential targets for new treatments
Increase knowledge of disease symptoms and burdens to everyday life
Appropriate trial procedures and reduced burden
Ensure the study design is culturally safe
A more diverse study population
Factor the patient voice into the protocol (such as when deciding the frequency of appointments and the number of procedures or assessments required)
Minimised burden (on the patient and their network)
Determining study endpoints
Assess patient reported outcomes (PROs), as they can be more meaningful to patients than physiological or pharmacological outcomes
Patients feel more listened to and that study staff value their quality of life
Understand patient’s wants and needs
Endpoints are included that are valued by patients
Inclusion/ exclusion criteria
Consider of general characteristics of the intended patient population
Avoid overly specific inclusion criteria
Problems with finding suitable participants are prevented
Conduct patient research into population characteristics
Optimal inclusion and exclusion criteria
Identify potential barriers to study participation that can help inform patient recruitment strategies and increase the likelihood of people taking part
Improved recruitment strategy and rate
Conduct research into diverse patient groups to understand perceptions / barriers to clinical trials
Increased diversity in the study population and relationship building in different communities
Know how people like to receive information (platform, time, frequency)
People fully understand the clinical trial and can make an informed decision about taking part
Increased empowerment from patients. They feel like their thoughts are being heard and they’re making a positive difference
Increased engagement, recruitment rates and retention rates, and greater diversity
Implement feedback from patients on supporting materials (including design and format)
User testing of materials to ensure they are clear and in lay language
Use patient research to convey understanding of patients wants and needs
Create engaging materials (that are approved by patients), which can be referred to throughout study participation
Learn from patients on their thoughts to implement strategies that improve the patient experience
Increased retention rates
Follow-up and end of study
Understand patient expectations when a clinical trial ends
Improved patient experience and centricity
Positive learnings to take to future clinical trials
Thank patients (and/or carers) when their participation ends and when the study finishes
Gain patient feedback on the overall trial experience
Table 1. Potential outcomes following patient engagement and implementation of patient feedback.
Beyond the overarching goals of clinical trials to improve treatments, quality of life and healthcare, your study needs to start and finish on time, provide an optimal patient experience, improve the reputation of clinical trials, meet recruitment and retention targets and ultimately yield robust findings. While this can seem overwhelming when there are short term goals to meet, introducing changes early can produce dramatically improved results. Patient engagement is fundamental in meeting these goals and also ensures patient centricity. Using different methods to gain key patient insights and creative campaigns can make the difference between success and failure, and here at COUCH Health we provide the solutions you need to effectively engage with patients and carers. If you would like to find out how COUCH Health can help you with any of the items mentioned and meeting your clinical trial goals, contact us at firstname.lastname@example.org.