Solving clients’ biggest clinical trial patient recruitment challenges
Clinical trial success is often determined by patient recruitment and retention strategies. Currently, many trials take longer than expected to enroll the necessary participants and poor recruitment and retention can lead to the discontinuation of clinical research.
A poll conducted before the webinar highlighted that more than 85% of respondents have faced clinical trial patient recruitment challenges and two in five (40%) said they find participant retention difficult. Issues included:
- understanding the patient perspective, including the need to appreciate cultural and socioeconomic differences
- overcoming obstacles that prevent people from participating in clinical research
- ensuring information is accessible and easy to understand for each patient population
- providing consistent care to patients across different geographical areas. This could involve patients in different states or counties, or completely different countries
- post-trial engagement with participants and maintaining follow-up calls.
At Innovative Trials, we have an impressive track record of accelerating patient recruitment in clinical trials, including for complex trials and those that had been or were at risk of, falling behind.
Understanding the patient perspective
As Laura notes during her opening presentation, a key component of our ability to recruit clinical trial patients is understanding their individual needs, motivations, and concerns.
“What we have to remember is that every patient is different. They have their own personality, their own expectations, their own motivations, cultural backgrounds and influence…”
For us, this ideally begins at the study design stage. Thinking deeply about the realities of living with a specific health condition, the psychological, physical and social impact a trial may have on participants, any perceived burden that might fall onto caregivers’ shoulders and the information they would want and need to ensure they are fully informed throughout the study will help ensure each clinical trial is built with the patient at its core. This, in turn, will make clinical trial patient recruitment and retention easier and more meaningful.
This thinking lies at the heart of everything we do, particularly our Navigator service. Designed to ensure clinical research patients get the tailored support they need throughout their clinical trial journey, our Navigator team is a direct patient-facing service that is already boosting clinical trial patient recruitment and retention for our clients.
Do not underestimate cultural influences
A person’s culture is integral to who they are. It is important to recognize this and ensure engagement with patients is culturally and linguistically appropriate. For some, they may not want others to know they are participating in a clinical trial. Others may want to consult family, friends and possibly community leaders before deciding whether or not to enroll.
Some patients may sign up because they want more time with a doctor in a hospital. Some may prefer a more local setting for their appointments. Some may welcome at-home visits while others may not.
Clinical trial patient recruitment challenges vary from country to country, but they can also vary between diverse populations within the same country. Having in-country experts available to engage directly with patients, such as our Navigators, can help overcome this barrier. Each Navigator will:
- speak the local language,
- understand the local healthcare landscape,
- be an expert in the local clinical trials arena,
- have insight into cultural factors that may influence clinical trial participation.
Overcoming obstacles to trial participation
Clinical trials can last several years and require ongoing commitment from patients. This can present various challenges to those participating. For example, all studies will require some form of monitoring. For those that are not 100% remote, this will include appointments with healthcare professionals. This may mean that participants need to arrange time off work, organise childcare or other forms of support, and consider how they will travel to those appointments.
It is also likely that they will be required to complete other tasks between such visits, such as:
- keeping samples at home
- using an electronic diary to record their progress
- reporting back to site staff regularly.
“Commitment and burden [are something] we see all the time,” says Kari. “Time commitment, distance to the site, number of study visits and length of study…that’s a lot of patient burden. Now if you pair these reasson with difficult-to-use study devices or study platforms, retention will be at risk due to the burden and commitment involved.”
Other obstacles could include local or global events, such as economic instability and uncertainty. Anxiety at the thought of participating in a clinical trial, driven by a lack of understanding of what clinical research involves, can be another obstacle.
Being aware of these challenges ahead of time and developing a strategy and tactics to mitigate these barriers will make a tangible difference to a patient’s clinical trial experience. Our global network of Clinical Enrolment Managers (CEMs) support sites to put effective trial optimization plans in place while our patient-facing Navigator service ensures participants get the information and support they need. This ranges from assisting in the set-up of study-related technology and troubleshooting any issues to being a listening ear, answering questions and helping to reduce feelings of anxiety, uncertainty and isolation that participants or caregivers may have.
Ensuring information is accessible and relevant
The general public’s knowledge of clinical trials remains low despite an uptick in understanding due to the COVID-19 pandemic. Too often, the materials designed to recruit clinical trial patients are long, complex and filled with scientific jargon. They can be overwhelming to read and understand.
From our own experience, we know people value information that is simple, written in their local language and presented in an easily digestible format. Materials should always address the key questions potential participants and caregivers are likely to have:
- What kind of study is this – decentralized / site-based / hybrid / fully remote – and what does this mean?
- What will be expected of me if I participate in this study?
- If I need to use an e-diary or a mobile app, will I be given a device to access these?
- If I need to complete site visits, how often and how long will these be? Where will I have to travel to and what will these visits be for?
- Is there any reimbursement available for costs incurred due to the trial (e.g. travel or childcare)?
- What is a placebo and what does it mean if I am given one?
At Innovative Trials, we develop bespoke patient materials for each study, tailored to diverse patient populations. And of course, our Navigator team can be commissioned as an ongoing source of information and support for patients throughout their clinical trial experience.
Providing consistent care across different geographical areas
A frequent question we are asked by sites is about ensuring patients receive consistent care if they are moving between states in the US or between countries. This includes making sure that they can continue that study in an alternative country.
Our global network of in-country Clinical Enrollment Managers (CEMs) and Patient Navigators means seamless continuity of care. Our teams can work closely together to ensure all relevant information is shared internally and with the sites themselves.
And of course, our Navigators will continue to provide a consistent point of contact for clinical trial participants, ready to answer their questions, listen to their concerns and support them throughout the entire clinical research experience.
Ongoing engagement with participants
With so many trials finding the process of enrollment difficult, it can be easy to think that the hard work is complete once all necessary participants are recruited. However, ongoing patient engagement has challenges all of its own.
Kari says, “We all know study sites are so so busy. They have multiple studies [and] multiple hats that they’re wearing every single day. If our Navigators can actually help the patients and have [a] quicker response to queries and issues and concerns that they’re having. You know, patients and sites ultimately will be happier.”
For Helen, our Navigators have been “instrumental” in overcoming some of the challenges associated with clinical trial patient recruitment and retention.
For one fully decentralized study that required participants to use an inhaler device and pair it with an online platform to record the data, our Navigator service was commissioned to support patients in how to use this equipment.
“It could be very difficult and challenging, even for the most tech-savvy individual to be able to pair and get the data to go into the portal,” admits Helen. “So, quickly [the Patient Navigator] came on board and became a subject matter expert for us.
“They have fielded multiple questions, patient stipends…and they quickly became an extension of our own staff.”
“I can’t say enough about my particular experience with the Navigators. I’ve worked very closely with them for a year now and our study is going to continue for a little bit longer, but has really changed the trajectory of the trial.”
Such glowing feedback is not uncommon for any of our services, but particularly our Navigator offering. Sites appreciate the support we provide, removing the burden of ongoing and time-consuming patient engagement from sites to allow them to focus on other areas of patient care. Clinical trial patients value this support too, which ensures they have a positive experience that will inevitably have implications for the future.
As Laura says, “We know that if we engage those participants throughout that journey of clinical research, then they’re more likely to speak about this to friends and family and tell them the importance of participating in the future, sharing that widely between people that they know. And crucially, they have that warm and fuzzy feeling that they’ve made an impact to the lives of others…and are therefore more likely to participate again.”