The decision to take part in a clinical trial ultimately lies with patients or caregivers. And with a number of factors influencing consent or assent to participate, it’s important that any barriers are addressed from the very beginning. Diversity, socioeconomic, geographic and financial factors are just a few of the many barriers that can influence a patient or caregivers’ decision when it comes to clinical trial participation. And these will undoubtedly impact patient recruitment, unless a well-planned and effective recruitment strategy is developed.
A well-planned recruitment strategy should include:
By following the points above, an effective patient recruitment strategy will best equip study sites and successfully inform and target the right patients, so that the likelihood of them choosing to take part is maximised. Furthermore, study sponsors and organisers must recognise that studies can place a large amount of burden on sites and their staff.
Therefore, as part of the planning for your patient recruitment strategy, action should also be taken to minimise this burden as much as possible, and to provide site staff with the knowledge and resources they need to efficiently identify and recruit patients. It is also worth noting that a patient recruitment strategy needs to be refined and considered, so it targets patients who are deemed ‘high quality’, meaning those who are most likely to meet the inclusion and exclusion criteria. In this way, efforts are not wasted by trying to target or recruit people who are unlikely to be eligible to take part.
Patient recruitment strategies also need to directly consider the patient persona, and both online and offline activities are therefore essential. In something as simple as producing either a printed leaflet or a website, we can recognise that different patients and caregivers like to digest information in different ways.
At the time of writing, there are over 300,000 studies listed on clinicaltrials.gov, meaning that millions of patients need to be recruited and take part. There is evidently a huge demand to recruit patients, but many studies are failing to do so. According to a GlobalData analysis of all terminated trials within the Clinical Trials Database, enrolment issues are the top factor in clinical trial terminations, with 55% of trials terminated due to low accrual rate. Enrolment issues and protocol amendments can also cause delays, resulting in huge costs for study sponsors.
Sponsors are faced with the challenge of not only understanding the patient and caregivers’ experience at different points of the patient journey, but the need to provide optimal support and tools every step of the way, to ensure their experience on the study is the best it can be. And with intense time pressures being an additional challenge that study sponsors face when it comes to managing a study from start to finish, this means that time is often not taken to gain key insights from patients and site staff, and patient recruitment strategies are not well thought-out or are non-existent. Without mapping the patient journey to understand their experience, and without creating a well thought-out strategy, patient recruitment and the overall outcome of the clinical trial can be affected. Plus, if sponsors do not prioritise the patient experience, this can dampen people’s perspectives of clinical research and will not help build trust or reputations within the industry.
Study site staff are also faced with challenges and conflicting priorities when trying to recruit patients. Many site staff mix clinical trials with their main clinical roles, so do not necessarily have the time to invest in learning about individual studies and the potential participants. If they are presented with lengthy documents, they may not have time to read them due to other priorities. In addition, if sites do not have specific study teams or a set process for patient recruitment, potential participants may frequently be missed. Furthermore, in terms of how the study is planned and executed, site staff do not input on study design so are unable to suggest changes that would aid recruitment. They also don’t usually have enough presence within the community and are not involved in outreach activities, which means they may have less of an understanding of diverse populations and how to target them.
At the patient level, lack of trust in clinical trials is a huge barrier to participation, especially among ethnic minority groups. Recent research from Demand Diversity showed that mistrust due to negative clinical trial experiences in the past (e.g., the Tuskegee Syphilis Study) is deeply rooted in society. Previous research has revealed this many times, and shows how the deep and justified mistrust is still having an impact today. A more recent example of this includes the underrepresentation of Black people in COVID-19 clinical trials. While Black people make up 13% of the U.S. population, they account for 21% of deaths from COVID-19, but only 3% of enrolees in vaccine trials.
Lack of trust can also stem from the belief that HCPs do not have the knowledge and insights in certain disease areas or diverse populations, therefore contributing to patient and caregivers’ hesitancy to take part in clinical trials. Especially if lack of education among HCPs has led to longer diagnosis times, or lack of understanding around their quality of life has led to negative experiences.
The pharma industry needs to understand that mistrust in healthcare and clinical trials still exists in society today, and that it is the industry’s responsibility to build upon this trust by improving their knowledge, gaining patient and caregiver insights, and taking action to provide positive patient experiences.
Practical barriers such as having time to attend frequent appointments at the study site are also a reason why patients opt not to take part in clinical trials. Studies that have been designed without considering the patient voice may risk creating high patient burden, and this can be off-putting even at the enrolment stage.
When you plan, you plan to succeed. Therefore, taking the time to think carefully about developing a robust recruitment strategy can save time further on and improve the chances of meeting targets. It’s important to address the need to recruit diverse populations, and how you will do this, as part of your planning. This thought process alone shows that you are taking everyone into consideration and doing your part to build an inclusive study. Your strategy should also be multifaceted, covering not only all channels to reach patients, but also considering other stakeholders and sites. As discussed, sponsors are faced with increasing time and costs challenges, so failing to prepare and implement the best strategy will only exacerbate these challenges. By predicting potential problems or barriers to patient recruitment, the best strategy will be prepared for all eventualities, show fluidity and longevity, and in the long term, help you meet targets more efficiently.
Investigator site support is a key element of any patient recruitment strategy, whether this support aims to boost recruitment or retention. With the challenges sites face, it’s important for study sponsors to equip and support sites as best they can. Investigator site support starts with education and awareness. Are the site staff ready to embrace your study and do they have sufficient knowledge to be motivated and recruit patients? It’s important to build relationships with sites from the start of your study and provide informative materials that are quick and easy to digest. This means that the sites will be fully prepared when recruitment starts. By providing a full suite of patient-facing materials, burden is removed from site staff when it comes to explaining the study. A full suite of materials should encompass both offline and online resources that site staff can refer patients too. Patient engagement solutions, particularly those encompassing the latest technology, also offer a way to maximise the patient experience while creating no extra work for sites. And in turn, patients will be more likely to continue taking part in the clinical study. Providing cultural safety training to sites can also help with patient recruitment, as well as achieving a diverse study population.
Participants have very specific drivers for joining a clinical study. They need to see that your study clearly understands their concerns and hopes, and keeps these central throughout their interactions. At the same time, each individual will have their own barriers that may limit their ability to take part. It is vital to fully understand these drivers and barriers before creating and implementing a patient recruitment strategy. Gathering this kind of insight can be done through developing patient personas. A typical patient persona would include basic demographics, and health-related, psychographic and ethnographic factors. It is important to gain insights and track experiences at every stage of the patient and caregiver journey, from pre-diagnosis to leaving a study. By tracking their experience and gaining feedback throughout their time on the trial and at the end, you can use these results to make necessary improvements, which in turn will create better patient experiences.
Conducting patient research can be made simpler by working with patient groups. It’s therefore essential to develop strong relationships with patient groups and patient advocates, globally, and across different conditions. Forming these relationships gives access to networks of patients who are willing to sharing insights that can lead to informed decision-making and positive outcomes.
Once these key insights are obtained and analysed, they can be used to guide the recruitment process and supporting materials. For example, the informed consent process needs to be simplified and clear to make the decision-making process easier for patients and caregivers. It is easy to lose potential participants at this stage by providing overwhelming scientific information, and if the study design is too demanding. All recruitment materials should support people in making an informed decision and provide accurate, clear information, without complex medical language and jargon. Simultaneously, content needs to truly speak to your audience and relate to how they feel, and thus be impactful, engaging and persuasive on an emotional level. Lastly, the targeting of patients and caregivers needs to be focussed and avoid mass communications, both offline and online.
Patient-facing materials are an important resource that can attract potential participants and provide information that is easy to digest. It is vital to balance creativity and compliance, and while design is important to get people to read the materials, the content is how you get your message across. Examples of print materials that can boost recruitment efforts include posters to attract potential participants, and information brochures or leaflets.
People are spending more time online than ever before, and it is often the first port of call when people are seeking health information. Furthermore, with 43% of patients using a ‘general internet search’ to look for clinical study information, it is critical to create an online presence for your study. This online presence should cover a website for your study, as well as advertising, to engage with the right people in the right way. All content needs to be easy to understand and consider that everyone has different levels of health literacy.
A website dedicated to your study is a perfect way to provide information that people can easily digest in their own time. But if it is not executed correctly, it could in fact hinder the digital patient recruitment process.
A huge factor that can determine the success of your website is whether it is inclusive and diverse, which can be reflected in your branding and the creatives on the website. When a patient lands on your study website, they want to be able to see themselves and understand whether this study is relevant for them. If the branding and creatives do not consider all genders, ages, ethnicities, learning abilities, and more, it is likely that some patients will click off your website because it is not relatable.
There are ways that you can ensure your study website is diverse and inclusive for successful patient recruitment:
The usability, appearance and information on study websites can also be a barrier if they do not align with patients’ or caregivers’ expectations. One study found that 94% of patients reject or mistrust healthcare websites due to design factors, including:
Therefore, it is essential to consider the patient voice in the design and copy of the website, alongside more technical aspects such as search engine optimisation (SEO) and user experience (UX).
SEO seeks to increase the quantity and quality of traffic to websites through organic search engine results. Simply, more relevant users will visit a clinical trial website, such as a patient who may have the relevant condition. It is important to consider SEO at the website build stage by selecting keywords that the patient and/or caregiver are searching for.
UX design is the process used to create products that provide relevant experiences to users, and considers branding, usability and functionality. Credibility and establishing trust are fundamental within recruitment strategies, and strong UX design is a vital part of this.
When done well, digital advertisements can help you reach the right audience, increase awareness of your study and help you boost recruitment numbers. However, if targeting a specific group, insights should first be gained into whether spending is prioritised in the right areas. For example, if your target patients are known to have a greater presence on Facebook vs other social media, it makes sense to prioritise promotional spending there first.
Social media is a powerful tool when it comes to your patient recruitment strategy, and can help you to engage with the “hard-to-reach” patients. There are many community leaders and patient groups that you can reach out to with the click of a button online, as well as the general population. However, before you do engage online, it’s important that you’ve done your research to ensure your messages are constructive and your adverts are in the right places. Your presence online can also help you to build trust and influence within communities. So remember, it is essential to invest time in the research phase prior to creating any adverts, to maximise understanding of your audience and create a strategy and advertisements that suit their ever-changing needs. As mentioned above, your content needs to be diverse and inclusive to ensure your content is relatable to all audiences.
Sequential advertising can be seen as a form of storytelling, by showing ads that best resonate with your target audience at specific points in time. This method helps to build trust and convey multiple messages to patient pools. This may be relevant if you want to try different ways of engaging with a broad patient population.
Retargeting can be used as a method of targeting a patient or caregiver who has already visited a study website but did not fill in the pre-screener. It is possible to monitor where the patient or caregiver has left the website and provide tailored content to persuade them to revisit the website and fill out the pre-screener. For example, an advert that states some of your study appointments can be done remotely may be a good way of targeting caregivers — who are often needed to accompany patients and/or organise travel to and from the study site.
Once potential participants have been identified through the advertising process, it is advantageous to ensure they go through an online pre-screening questionnaire. This avoids wasting time or effort on speaking to patients who do not meet the main eligibility criteria for the study. Following this, patients who meet the criteria should be followed up promptly by a nurse call centre to go through a screening process. This further reduces site burden as it leads to high quality patients being referred to sites. Patient recruitment is not a short process; an end-to-end solution is required to ensure patients are supported on their journey, right from the beginning to the very end. Utilising platforms that contain all of the relevant information in one place can be a great solution for patient recruitment and helps to keep patients and potential participants engaged throughout the process. For example, a unified platform that enables patients and caregivers to learn more about a disease area, the relevant clinical trials that are recruiting and who can qualify, all in one place, could boost patient recruitment. Furthermore, a virtual engagement app that provides “a one-stop-shop” for all the information patients need regarding the study they’re enrolled onto, and ways to communicate all in one place, can contribute to a positive patient experience. It is vital to nurture and follow up with patients to ensure they are not lost and that they continue through the recruitment process, and platforms like these can certainly help.
One of the most important elements of a recruitment strategy is to continually analyse and update accordingly. All digital campaigns should be monitored for performance, and materials A/B tested at all times.
However, the analysis is not only through data, but also through obtaining quantitative and qualitative feedback from patients and caregivers on the supporting materials they were given, and the entire recruitment process. This helps to inform any changes that need to be made that will improve the recruitment strategy going forward.
This recommended patient recruitment process can be summarised in 5 key steps:
It’s crucial to remember that the patient recruitment strategy must be adaptable to change based on ongoing analyses. Once recruitment begins, it’s important to constantly reflect and refine the approach to make sure the strategy is the best it can be. Well planned strategies will consider all channels to recruitment, but to achieve the greatest success, these channels will be focussed on different strengths, to ensure the chances of reaching the target audience are maximised. Patient recruitment strategies also must consider the investigator sites and ways to reduce burden, through efficiently educating site staff, equipping them with recruitment tools and enabling them to refer patients to engagement solutions in order to minimise dropouts.
It is clear that there is much to consider for a well-rounded, robust patient recruitment strategy and this guide simply touches on some of the main elements. To discuss this more, get in touch with our specialists at firstname.lastname@example.org.