Improving patient recruitment and retention in China
8 min
Results of a Parexel Study of Patients’ And Healthcare Professionals’ Attitudes to Clinical Trial Designs and Participation
Patient recruitment and retention are challenging for clinical trials in China, and researchers have been slow to adopt tools and techniques for decentralized trials (DCTs), such as wearables and home nursing visits.
To examine these problems, Parexel conducted a qualitative survey of 20 patients and 24 good-clinical-practice compliance officers, principal investigators (PIs), and external and internal clinical research coordinators (CRCs) in China. We followed this with a quantitative survey of 76 patients and nine caregivers.
Challenges to recruitment and retention
We found a number of challenges to patient recruitment, including limited access to trial information or misunderstanding of what a particular trial was about, alternative treatment options, fierce competition among trials for patients, high screening failure rates against strict inclusion criteria, and low confidence of family members or caregivers that the patient would benefit from the trial.
Challenges to patient retention included fear of a poor outcome or adverse event, family or caregivers’ lack of confidence, lack of caregiver support, unexpected site-visit frequency, and inadequate support and communication from the PI or CRC.
Patients fall into three categories
Every patient is unique, and each has different expectations of a trial and impediments to participating. However, we grouped those in our survey by some common characteristics using a clustering method and found three distinct attitudes toward clinical trials.
1. Desperate help-seekers
Patients who see clinical trials as their last option to sustain their life. They have a relatively high disease burden and perceive their disease as very serious. They may have disabilities related to their condition. On the whole, they have a relatively low household income and education level.
2. Active trial hunter
Patients who are knowledgeable about their disease and eager to seek the best-matched treatment. They have moderate disease severity and may have disabilities related to their condition. They are more likely to have a higher education level and household income, as well as better access to information about clinical trials. They are open to multiple recruitment sources.
3. Peaceful observer
This segment consists of patients who like to learn about trial opportunities and are willing to explore treatments that might be better than they are on. They have a relatively light disease burden and perceive their disease severity as relatively low or moderate. They may have disabilities related to their condition. Their household income and education levels vary.
Participation in clinical trials
We discovered that the most important motivator for patients to participate in a clinical trial is to find a treatment for their condition, either because they have no other option or because the trial offers a better option than existing treatments. Other motivations include contributing to the cause of medicine and earning compensation.
The top reasons to participate in a trial differ subtly by segment. Sixty-two percent of desperate help-seekers believe a trial they choose to participate in is their last chance, 76 percent of active trial hunters believe a trial is the best match for their condition, and 81 percent of peaceful observers believe a trial is an opportunity to try a better treatment than their current one.
Obstacles to clinical trial participation for three patient segments (Figure 1)
The obstacles to participation vary by segment (Figure 1). Overall, the most significant is patients not being aware of the availability of clinical trials. Second, they may find it difficult to understand the process of signing up for a trial, especially if the sponsor does not provide clear guidance. Finally, patients may be concerned about the effectiveness and safety of a trial.
The most critical decision point for patients is enrollment. Patients can be positively influenced by affirmation and reassurance from a healthcare provider, principal investigator, or clinical research coordinator, emotional support from family or friends, and positive online feedback about the trial drug.
The case for decentralized trials
Diversity and inclusion in trials can be negatively affected by inadequate accessibility. Patients living in remote areas may have limited access to trial opportunities and, therefore, may not be considered in the first place. Those with disabilities may face exclusion or difficulties participating in and adhering to trial activities, while patients from minority ethnic groups may be naturally excluded from trials because of smaller population sizes or language barriers.
Sponsors can help overcome these barriers and increase participation by reducing patients’ need to travel to a medical center. Patients value the convenience of avoiding travel to trial sites, while site stakeholders see it as beneficial for patients who live far away but may help with retention. All stakeholders favor remote solutions for recruitment and remote data capture (Figure 2) where practical.
However, stakeholders have concerns that impede the adoption of DCTs. Patients and professionals express concerns about the lack of face-to-face communication, limited personal contact, and the risk of privacy breaches. Patients are wary of remote sampling and home health services, and professionals worry about regulatory compliance, communication, and privacy. Furthermore, the perceived lack of a formal regulatory framework governing DCT solutions is a roadblock for some hospitals.
Stakeholders have concerns that impede the adoption of DCTs. Patients and professionals express concerns about the lack of face-to-face communication, limited personal contact, and the risk of privacy breaches.
Stakeholder's interest in decentralized clinical trial tools (Figure 2)
Improving recruitment and retention
Because the patient segments have different concerns around recruitment and retention, the best strategies for improving them vary, too. But overall, the most important for recruitment is to leverage HCPs’ influence on patients by making the HCPs more aware of trials. Sponsors can also make trial information more visible in hospital-related channels, such as their website or WeChat account. They should also share comprehensive trial information and easy-to-read inclusion criteria on specialized recruitment platforms. And they can encourage the sharing of patient success stories and the exchange of trial information in online patient communities.
To retain patients, it’s important to provide tangible logistics support, such as car service or subsidies, to overcome issues of disability or distance, especially for those without adequate caregiver support. Engaging closely with participants through exclusive medical services provided by top physicians, optimizing the trial process through schedules that minimize the impact on participants’ daily lives, and leveraging digital platforms and CRCs to address communication needs are also key.
And remember, not all patients or segments are equal. Desperate help-seekers most need opportunities to be brought to them, active trial hunters are most influenced by HCPs, and peaceful observers most value being kept aware of trial progress, results, and future research.
The main hurdles to participation by patient segment are:
- Low awareness of trial opportunities
- Limited knowledge about enrollment
- Concerns over logistics
- Trial efficacy and safety concerns
- Trial efficacy and safety concerns
- Mismatch between trial drug and disease condition
- Low awareness of sign-up method
- Other treatment options available
- Low awareness of trial opportunities
- Trial efficacy and safety concerns
- Low awareness of sign-up method
- Limited reserve patient pool in general hospitals
Contributing Expert