One of the greatest challenges facing clinical trials is recruitment. It can be extremely difficult to recruit enough participants to take part in a clinical trial. In fact, it is so difficult that the majority of clinical trials fall short of the number of people they need, with some trials even struggling to recruit a single participant.
There are a number of factors that either limit the patients who are available to participate or deter potential participants from joining a clinical trial. Specifically, the trial site burden and location of the clinical trial site can present major barriers to participation.
To counteract these challenges, more and more clinical studies are opting for decentralised trial designs. Decentralised trials can help improve patient recruitment drastically, by removing site and geographical limitations.
What are Decentralised Clinical Trials?
A decentralised clinical trial (DCT) involves performing some or all of the tasks linked to a clinical trial at sites other than the conventional clinical trial centre. These alternative sites could be at the participant’s residence, a nearby healthcare facility, or even a local laboratory.
Decentralised trials can improve patient recruitment by facilitating better access and convenience in clinical trials, ultimately enhancing the trial’s chances of success. It can result in a more extensive dataset due to a larger sample size and can also lead to cost savings in terms of recruitment expenses.
How Does a Traditional Clinical Trial Model Compare?
A more traditional style clinical trial model is focused around participants visiting a centralised location, where the trial takes place, and where the results can be analysed.
The Role of Patient Recruitment in Clinical Research
Participant retention plays a crucial role in the success of clinical studies, a widely acknowledged fact. About 85% of clinical trials fall short of their patient enrolment targets, leading 80% of all trials being delayed. The effectiveness of participant recruitment for a clinical trial can vary, ranging from resounding successes to complete failures. A shocking statistic is that 11% of all clinical research sites struggle to enrol even one participant.
The expenses associated with recruiting participants for clinical trials can be exorbitant. Delays of just one day can incur costs ranging from £450,000 to £6,000,000, depending on the trial’s scale. As a response to these challenges, a need has arisen to explore solutions that not only attract more individuals to participate but also ensure their continued engagement throughout the trial.
Enhancing both patient recruitment and retention significantly elevates the prospects of a successful clinical trial. This outcome not only leads to a larger sample size, resulting in more precise data, but also eliminates the need for additional recruitment drives, thus reducing costs.
A pivotal factor in augmenting recruitment success and retaining existing patients is alleviating the burden on trial sites. The dropout rate for clinical trials averages between 15-40%, a range that can profoundly impact a trial’s success. By streamlining the process and reducing obstacles, participants are more likely to see the trial through. This recognition serves as a driving force for the research community to prioritise participants and alleviate these challenges.
Common Challenges to Patient Recruitment in Clinical Trials
Due to the nature of the clinical trial process, there are often inherent challenges or barriers to entry that make potential participants less likely to join, or lead them to drop out part way through the trial. The factors that contribute to both of these, are commonly referred to as ‘site burden’. Some of the most common factors that create site burden are:
Lengthy Travelling
One of the major factors that can be off-putting for patients either before a medical trial or even during, is the lengthy commute to a clinical site. Around 70% of people live over 2 hours away from a clinical site, meaning that travelling to the site can significantly impact their daily schedule. This problem becomes even more cumbersome if a patient can’t drive or doesn’t have access to a car, as they would need to rely on public transport.
The commute can be very inconvenient, especially if multiple visits are required, and can often put people off joining in clinical trials, or make them drop out part way through. This impact on recruitment and retention can impact the success of the trial and possibly incur large financial costs.
No Flexibility in Participation Hours
A large factor that can reduce the number of participants who sign up for a clinical trial is a lack of flexibility. People have busy lives, often having to juggle both full-time jobs and their personal lives. A clinical trial that demands people can only participate at strict dates and times means people might have to take time off work, or have schedule clashes.
A lack of flexibility around this can cause people to pull out of signing up, or drop out part way through, as participating in the clinical trial would severely impact their day-to-day schedule.
How Decentralised Trials Address Patient Recruitment Challenges
One of the major features of a decentralised clinical trial model is that it, by necessity, addresses the lack of flexibility that can be seen in centralised clinical trials. Solutions had to be developed that would mean that clinical studies would still be able to go ahead, despite the lack of a central clinical trial location.
One of the results of using a decentralised clinical trial model is that the process is more convenient for participants, hopefully making the option more appealing. This can make patient recruitment easier, and encourage better retention of enrolled patient, which can result in larger sample sizes, boosting the chances of getting the data wanted from the trial.
Utilising technology
Embracing a decentralised approach can prove highly effective in easing the logistical demands on participants. The use of electronic forms for questionnaires and consent negates the need for unnecessary travel.
Moreover, researchers can explore remote options, such as video calls, when direct interactions between researchers and participants are needed. Implementing this approach substantially alleviates the multiple inconveniences participants may encounter, ultimately enhancing their overall study experience.
At-home visits
For clinical studies that necessitate biospecimen collections and quantitative data gathering, employing mobile nurses for data collection can be a strategic advantage. This method efficiently eliminates the need for participants to visit study sites. By deploying healthcare professionals to participants’ residences or arranging meetings at nearby healthcare facilities, researchers can seamlessly obtain the required data while minimising the logistical challenges participants face.
Multiple Site Locations
With so many patients living more than 2 hours from a dedicated clinical trial site, one of the advantages of a decentralised clinical trial approach is that it presents the opportunity to use multiple, temporary locations that participants can visit.
This means there is a higher chance of a participant not having to travel as far, reducing the logistical issues. In addition, it’s likely to take up less of their time, which can help if they need to juggle other elements in their schedule such as work or family commitments.
Enhancing Diversity and Inclusivity in Trial Populations
One of the biggest benefits that using a decentralised clinical trial model has for participant recruitment, is that it allows for not only more people to take part, but also a wider range of people. Not being centralised, and therefore either having multiple locations or remote capabilities, allows for people who can’t normally travel long distances to take part in a clinical trial.
This can enhance the diversity and inclusivity of a trial, giving the opportunity for people to join who might be restricted from doing so normally, whether that’s because of financial, medical, accessibility, or any other reason.
Enhancing Diversity
In the pursuit of inclusive patient recruitment, it’s crucial to ensure that under-represented patient populations are included in clinical trials. In addition to employing various strategies such as broadening eligibility criteria, collaborating with community-based medical centres, and engaging patient advocacy groups, there are two direct avenues through which patient diversity can be enhanced via decentralised clinical trials.
Establish Sites in New Communities
Leveraging decentralised clinical trial technologies empowers clinics that may not have previous research experience to conduct studies. This approach allows patients to stay under the care of their existing healthcare providers, fostering trust and minimising the need for distant clinic visits. Patients who may be hesitant to travel to major medical centres can enrol more conveniently.
Tailor Sites to the Patient
The traditional centralised approach involved setting up a trial site and then recruiting patients to that location. In the decentralised model, a “site” can be as simple as the connection between a single patient and their healthcare provider. In some instances, the patient’s own phone or laptop could serve as the ‘site’.
Ultimately, decentralisation facilitates hyper-local trials, liberating research from the confines of large medical centres and bringing it to locations where a diverse range of participants feel most comfortable and are therefore more likely to participate.
Eligibility criteria
Site visits can be exceptionally burdensome for patients managing medical conditions, creating substantial obstacles to their participation. Juggling the responsibilities of daily life alongside a medical condition is already challenging, and the inclusion of site visits and travel only exacerbates these difficulties. This issue can contribute as one of the foremost factors contributing to the burden placed on clinical trial sites.
To address this concern, researchers should proactively offer tailored solutions that align with the unique needs of patients. To gain deeper insights into your patient population, consider conducting focus group studies or collaborating with advocacy organisations to gain a comprehensive understanding of the genuine requirements of patients. Not only will this deepen the understanding of a patient’s needs, but should also increase how many people are able to take part in the trial, as you’ve eliminated potential obstacles.
Accessibility
To ensure that participants with physical disabilities or mobility limitations can comfortably engage in the trial, it’s vital to make the trial site fully accessible. This entails offering wheelchair access, installing ramps and elevators, and providing suitable assistance for individuals with visual or hearing impairments. An integral aspect of this effort may involve incorporating virtual check-in procedures, which serve to not only reduce the frequency of in-person site visits but also play a crucial role in reducing participation obstacles.
Benefits of Decentralised Trials for Patients
The biggest patient-facing benefits that come from decentralised clinical trials is a major reduction in site burden, and impact on their daily lives. A decentralised approach should make accessing a site more convenient, as more local healthcare centres or sites can be used, which can dramatically reduce a patient’s travel time.
In addition to this, virtual check-ins from a patient’s home when a “face-to-face” conversation is needed, not only eliminates the need to travel, but also makes it much more likely for the patient to be comfortable.
By eliminating factors that can cause stress, major impacts to their schedules, and any other inconveniences, patients are much more likely to remain happy throughout the clinical trial process. This can result in higher levels of patient recruitment and retention.
Benefits of Decentralised Trials for Sponsors and CROs
A decentralised clinical trial approach doesn’t just benefit patients, but also presents some significant benefits to a trial’s sponsors and CROs.
Increased Patient Recruitment and Retention
One of the biggest advantages that decentralised clinical trials presents for both sponsors and CROs is the increase in both patient recruitment and the retention of them. Because DCTs offer a more flexible approach to join clinical trials, more people are willing to join and stay on clinical trials, as there is less impact on their everyday lives.
This results in clinical trials being more likely to hit their recruitment targets, and therefore the study will present more accurate data, due to the larger sample size. This can contribute significantly to the success of the overall study.
Accelerating recruitment timelines
Due to decentralised clinical trials presenting the opportunity for more people to participate, not only can more people join, but hitting initial recruitment targets can be faster too. This can reduce the overall timeline of recruitment, and makes it less likely for delays to be incurred, which can result in massive financial costs.
Reducing costs and operational complexities
Another significant benefit to decentralised clinical trials for sponsors and CROs is that both the costs and operational complexities involved in a clinical trial can be reduced. The are 2 big contributors to this:
- By temporarily utilising existing local healthcare centres and labs, there is no need to pay for the use of a permanent location, which can save a lot of costs. Additionally the complexities of running your own site is eliminated, as instead you can communicate with existing sites and utilise their infrastructure.
- As recruitment is more likely to be successful, there is a lower chance of delays occurring, which as mentioned earlier, can bring about hefty financial costs.
Conclusion
Decentralised clinical trials offer a modern approach to conducting clinical studies, which make use of existing healthcare centres, sites, and technology to reduce the time and travel impact on participants. This can result in major benefits for both patients and CROs. Patients benefit from experiencing less site burden, and overall should be more comfortable throughout the trial process. Whereas sponsors and CROs benefit from reduced operational costs and complexities, along with an improvement to both patient recruitment and retention, which can contribute to the overall success of the study.
Interested in How a Decentralised Clinical Trial Approach Can Help with Your Patient Recruitment?
At Simbec-Orion, our team of experts are extremely proficient in clinical trial management. We tailor our clinical trial services to align seamlessly with your unique needs at every phase of the clinical trial journey. Whether you require support in patient recruitment, laboratory services, or data management, our team possesses the knowledge and resources necessary to ensure the successful execution of your clinical trial.
If you’re ready to collaborate with us, and to see how we can help design and implement a decentralised clinical trials model to your study, so you can experience the benefits, then get in touch with us today.