Recruitment and retention continue to cause significant and costly delays for clinical trials worldwide. Globally, more than 80% of trials fail to enroll on time, and up to 40% of patients drop out before completion.
To improve recruitment rates, sponsors and CROs should consider how they might remove barriers to participation and ensure that patient-centricity is at the heart of trial design.
In this article, we consider how, through the use of decentralization and technological advancements, we can further close the inequity gap in clinical research while maximizing outcomes for participants and sponsors.
Financial burdens are often cited as one of the biggest barriers to clinical trial participation, with 30% of patients enrolled on a cancer trial reporting financial concerns as a result of trial participation. Patients are deterred by the perceived cost of research participation, even if their expenses are covered. This is often due to concerns over slow or complex reimbursements and a fear of being left to pay expenses out of their own pockets.
Traveling to and from study sites can understandably put a financial strain on patients and their families. They often have to pay upfront for transportation, accommodation, and related expenses, and they may be forced to wait a long time to be reimbursed. In addition, patients may also lose money if they have to take time off work.
Broadening participation to improve health equity
To produce optimal results, clinical trials need to be accessible to everyone. However, the statistics show that participation isn’t equal. In the US, for example, people of color make up 40% of the population, but around 80% of clinical trial participants are white.
Historically, evidence from clinical trials has shown that drugs affect people of different ethnicities in different ways. Certain drugs, such as antidepressants and blood pressure medication, can be less effective in some population groups.
Underrepresented racial and ethnic communities often face critical barriers for participation, including the following::
- Mistrust of the medical community
- Lack of familiarity with the clinical trial process
- Lack of information about the existence and importance of clinical trials
- Time and resource constraints associated with clinical trial participation
To address these issues, sponsors, and CROs must design trials to be inclusive for all participants from the start. Trial organizers should first seek to engage with local communities to build trust and awareness before the trial begins. As a result, organizers can also better understand the needs of the communities and potential participants through important contacts, including influential figures who represent these communities.
Secondly, education is especially important to help overcome barriers to participation. By engaging with community leaders, cultural ambassadors, and trusted local voices, trial designers will be well placed to answer questions and provide support both before and during the trial.
Decentralization to improve access for all
The landscape of clinical trials has significantly evolved as a result of the global COVID-19 pandemic. In particular, decentralized and hybrid models have drawn attention.
Hybrid and decentralized trial design can make clinical trials more accessible, breaking down the barriers to participation for patients who aren’t able to attend study sites. This barrier could be the result of complex travel and/or logistical arrangements, financial burdens, or the impact of their disease or lifestyle requirements.
Mobile research or nursing units are an innovative solution to such barriers. Mobile units offer fully functional clinical study facilities and act as an additional, more accessible trial site. These facilities can bring people and technology together effectively and conveniently while easing the burden of travel. The result is a win-win for sponsors/CROs and patients; not only will outcomes for both be maximized, but the health equity gap too will continue to close.
Patient-focused health technology
Decentralization is possible through improvements in health technology. The use of convenience-enhancing solutions, such as apps and digital platforms, can improve trial participation and reduce barriers for underrepresented populations.
Emerging technologies have been shown to reduce barriers to accessing treatment and expand inclusivity in trials. The right technology can enhance the “human touch” in patient services while streamlining operations across the health ecosystem.
Automated financial payment platforms can support patients on their clinical trial journey by providing an integrated system to quickly and simply manage their expenses and reimbursements. These platforms provide patients with a high degree of control while reducing barriers to trial participation and retention.
A mobile app can help clinical trial patients manage their own payments and expenses, view travel and logistics, learn more about the study and their visits, and receive personalized support in real-time.
Addressing patients’ logistical and financial challenges not only improves recruitment but also increases patient satisfaction and improves the overall experience of research participation.
By incorporating patient input and focusing on their needs and priorities, we can create more patient-centric clinical trials.
Happier patients are more engaged and far more likely to stay on the trial until completion, which has a vital impact on study outcomes. Importantly, when we remove the barriers to participation for underrepresented patients, we create a more fair and equitable healthcare system for everyone.
We’re on a mission to break down barriers to participation in clinical research and make clinical trials accessible to everyone. To find out more about how we’re revolutionizing the patient experience, click here.