Patient recruitment for clinical trials continues to be a major problem for researchers today. By some estimates, up to 85 percent of trials fail to recruit an adequate number of patients. Furthermore, nearly 80 percent of trials can become delayed due to recruitment issues. These dreary statistics, combined with high patient dropout and poor retention rates, make optimizing a trial’s recruitment strategy a high priority.
Accomplishing patient recruitment success is a key factor of overall clinical trial success. Focusing on the patient and creating patient-centric, well-thought-out protocols while implementing available resources can go a long way towards achieving recruitment success. Here are a few strategies to optimize clinical trial recruitment:
Understanding Regulatory Requirements
Before beginning the recruitment process, a trial must meet all regulatory requirements established by the US Food and Drug Administration (FDA) or equivalent to conduct the trial. Different regulating bodies provide different guidance on the recruitment process in clinical trials, so it is important to know where recruitment is taking place and what rules will have to be followed.
The FDA recommends and even encourages early communication throughout the clinical trial design process. In addition, it provides guidance on media advertising and other tactics used to recruit patients.
Considering Financial Burden
Another consideration researchers should make prior to conducting a trial involves the expected financial burden of patient recruitment. Finding enough of the right, willing patients across multiple study sites and facilitating the patient to study completion can be financially troublesome.
It can cost thousands of dollars to recruit one patient to a study, and some studies estimate 30 percent of patients will drop out of clinical trials, leading to further recruitment and financial distress.
In the world of clinical trials, time is money. As previously mentioned, it costs money to enroll patients in a trial. Similarly, when patients drop out of trials, a large amount of study time and resources is wasted. Depending on the type and scope of the trial, as much as $600,000 to $8,000,000 per day can be lost for trials that are delayed.
Issues with recruitment can also result in lost patient data and advocacy involved with the trial, possibly further impacting trial-related costs. Insufficient data related to patient dropout can jeopardize the study results while costing exorbitant amounts of money.
Additionally, studies that provide incentives to enrolled patients need to account for the cost of compensation and ensure it is adequate for the given population to prevent patient dropout.
Optimizing Protocol
One of the most direct, effective ways to proactively streamline the patient recruitment and retention process is to design a well-optimized study protocol. The protocol should be patient-centric and encourage the patient to enroll and remain in the study.
Poorly optimized trials can lead to patients being less likely to enroll. For example, some protocols can be overly confusing or difficult to understand for some patients. Furthermore, some protocols may ask too much from patients to not be conducive to patient retention, such as too many unnecessary patient visits or phone calls.
What Are Some Ways To Optimize Trial Recruitment?
There are several methods commonly used to recruit patients. The most successful recruitment tactics involve clear communication and convenience. Let’s take a look at the best ways to optimize trial recruitment below.
Patient-Centric Protocol Designs
Providing patients with what they need and expect from participating in a trial can go a long way in promoting higher levels of recruitment and retention. One popular method to improve recruitment involves every patient receiving recruitment materials that are directed toward the patient.
Easy-to-read, patient-level health literacy materials have been proven to educate the patient about the purpose of a trial as well as make the patient feel more involved in facilitating the trial’s success.
Commonly, materials can be in the form of brochures, flyers, posters, or letters. Some patients may benefit from translated materials in their native language.
As a study progresses, participants may also benefit from a feedback loop. Gathering constant feedback during the trial can help identify problems proactively and assess how the study will solve them. Feedback can also help participants to continue to feel involved in the trial, which may benefit study retention.
Engage Family Members
Family members play a substantial role in patient healthcare. From moral support to literal transportation to and from appointments, the benefit of incorporating family into a patient’s healthcare plan cannot be understated. Including family members in the overall recruitment process and obtaining their trust and support can be invaluable.
Implementing a patient’s family into a recruitment plan can increase patient accountability and satisfaction in the study. Family members also improve the ability of patients to engage in open discussion about the study as well as increase the degree of understanding when obtaining informed consent. Often, caregivers are a family member and are essential to making sure a patient fully participates in a study.
Another way to involve a different kind of family is through community outreach. Studies have shown that support from the community can be just as beneficial to patient satisfaction in a study as their own biological family.
Implement Technology
Technology is integrated into nearly every facet of society today. It should be no surprise that researchers are capitalizing on this by advertising and optimizing patient recruitment through various technological sources.
Advertisements for many studies can now be found through social media apps and websites. Television, radio, and even newspapers are all also exploited for their large target audience to enroll patients. To further target and optimize this approach, media management companies employ media buying services to ensure the placement of advertisements are in the most appropriate advertising areas.
Provide Incentives
When confronted with the decision of whether to consent to a clinical trial, many patients will wonder what is in it for them. Incentives are an effective method of rewarding the patient for study participation. While many studies have shown altruism to be the most important reason patients want to contribute to research, patients still want to feel appreciated for their time and effort.
Incentives do not always have to be monetary in nature. Covering patient-visit travel expenses or offering to pay for any other logistical barrier to study participation can help. Incentives do not always have to be for the trial participant, either. Recruiters at study sites can be paid for performance in return for successfully recruiting eligible patients.
How Can You Improve Clinical Trial Feasibility?
Clinical trial feasibility is a term applied to the process of obtaining optimal completion cost, time, and target information when evaluating the prospect of performing a clinical trial in a given geographical area and patient population. Ultimately, identifying solutions to improve clinical trial feasibility in advance will improve trial recruitment, efficiency, and completion rate.
One of the largest challenges to the success of a trial is patient recruitment. Despite well-thought-out eligibility inclusion and exclusion criteria, studies commonly fail to recruit patients in a timely manner.
Site selection, poor selection of target numbers of patients in each site, unrealistic enrollment time estimation, improper protocol design, and competition with other study recruitment all contribute to common pitfalls in the process.
Some strategies to improve site feasibility include mathematical modeling, evidence-based feasibility, increasing the number of in-person site visits, developing better recruitment and retention strategies, and refining the site questionnaire.
Modeling and evidence-based feasibility implementation utilize computer software to simulate certain characteristics of the proposed study, such as how many countries and sites are needed to meet enrollment deadlines or what proportion of a site’s population needs to possess a diagnostic criterion.
Additionally, regular check-in and self-assessment during the recruitment phase can prove just as valuable as planning ahead. Tracking site enrollment closely can give study sponsors more insight into how enrollment is going.
They can then check a specific site and terminate sites early if recruitment is not on schedule. Closing randomization early or having a set randomization end date can help keep the trial on track as well.
The Bottom Line
Clinical Research Organizations (CRO) can be immensely helpful in orchestrating a clinical trial. CROs can considerably improve the efficiency, scalability, and overall success of a clinical trial. While utilizing a CRO is an investment, some CROs can provide global clinical trial support and expertise in the fields of pharmaceuticals, biotechnology, and medical devices that can prove to be invaluable.
CROs can help navigate some of the problems and considerations previously discussed, such as regulatory concerns and protocol optimization. At iProcess Global Research, you can expect exceptional teams and operations to provide cutting-edge research to help organizations with clinical trials.
With a constant demand for clinical trials, iProcess continues to meet the demand for specialists who can provide the high level of quality and competence required to facilitate clinical trial recruitment for success.
Sources:
How to Optimize Patient Recruitment | PMC
Optimizing Clinical Trials Recruitment via Deep Learning | NIH
