Preparation is critical before any successful trial commencement. We can overcome various recruitment challenges by focusing on the patient and creating patient-centric, well-thought-out protocols while implementing available resources.
Below we will discuss solutions to many of the most significant problems in clinical trial recruitment.
What Are the Most Significant Clinical Trial Recruitment Challenges?
There are several challenges to clinical trial recruitment. Let’s discuss the most significant, including cost, protocols, engagement, and more.
Challenge: High Cost
Quite possibly, the most upfront, obvious challenge in clinical trial recruitment is cost. The financial component of any clinical trial can be astronomical, but expenses directly related to recruitment can be deceptively high.
Where do costs occur within recruitment efforts? Hiring or contracting the right team of recruiters as a starting point can be expensive, especially if the study spans multiple sites and recruits over many years.
Study advertising and incentive payouts can add up, as well. Television, radio, social media, and even physical handout advertising can be costly depending on where and how often the study advertises.
Unfortunately, unforeseen costs are another expense clinical trial coordinators should consider. Trial delays related to recruitment issues can cost studies anywhere from thousands to millions of dollars.
Additional issues with recruitment, including lost patient data and lower-than-expected patient retention, can also severely impact a trial’s budget.
How To Prepare
Budgeting ahead of time can most directly prepare the trial for financial success. Still, a patient-centric protocol can often help keep a trial’s recruitment process on track with fewer surprises.
Facilitating easier patient recruitment and reducing patient dropout can keep a trial moving forward and avoid many unexpected expenses.
Additionally, utilizing a clinical research organization (CRO) can allow recruitment to be overseen by experienced researchers leading to even fewer financial setbacks.
Challenge: Poorly Optimized Protocol
Besides the high costs associated with clinical trial recruitment, a poorly optimized protocol can introduce a completely different set of challenges. Protocols that are overly confusing or unappealing to the targeted patient population will be a hard sell when it comes time for recruitment to begin.
The study protocol does not pertain to just the study design, either.
Site selection can be a significant issue when it comes to recruitment. Some sites simply are not conducive to recruitment, either from a logistical standpoint with study personnel or from a lack of sufficient patient perspective.
How To Prepare
Providing patients with what they need and expect from participating in a trial can promote higher recruitment and retention levels. One popular method to improve recruitment involves every patient receiving recruitment materials that are directed toward the patient.
An easy way to make a protocol more patient-centric is to provide study materials in an easy-to-read, appropriately written format. Many patients have low health literacy, so advertising materials should be designed with a 4th to 6th-grade reading level in mind.
Implementing physician referrals into the recruitment effort can be beneficial as well. Establishing a well-connected network of primary care providers can be more effective in recruiting patients than relying on word of mouth and advertising strategies.
Challenge: Failing To Engage Family and Friends
Family and friends form the foundation of the patient’s support group. Without them, many patients would experience dramatically decreased adherence to their care plan.
Outside of emotional and mental support, family members often physically support patients through home care and even transportation to and from appointments or follow-up visits.
How To Prepare
Patient satisfaction and accountability significantly increase when family members are involved in their participation in a clinical trial. Including the family in initial recruitment conversations can make a vital difference in the patient’s understanding of the study.
Be prepared to include family members who can translate essential details of a trial.
A family member’s approval to participate in a clinical trial can dramatically impact a patient’s decision to consent. Including the family member in the initial discussion of the study, if appropriate, can be an effective strategy to garner trust and ultimately facilitate recruitment.
Challenge: Failing To Implement Technology
The challenge of implementing technology is failing to take advantage of every cost-effective, efficient resource available to trial recruitment efforts.
Older, less robust advertising methods such as television, radio, and newspapers can be more expensive and less effective than current, more modern strategies.
Depending on the target demographic, failing to tap into social media and other widespread online formats can negatively impact your recruitment efforts.
How To Prepare
Digital advertising has never been more critical in the technologically integrated society we live in today. Social media reaches billions of people at any given moment and is used almost daily by the majority of the people in the world with access to it.
Despite how widespread social media and online advertising can be, it is usually much cheaper than less effective forms of older advertising.
For most potential patients, online advertising can effectively distribute information about the study and include direct links to websites where they can even enroll or learn more.
Challenge: Failure To Provide Incentives
Despite altruism being the number one reason patients participate in research, incentives can make a massive difference in recruitment and retention success.
Failing to offer adequate compensation for a study participant’s time and effort is an easily avoidable pitfall in the study recruitment process.
How To Prepare
Incentives in a modest monetary amount are the most common and effective way to promote clinical trial participation. However, they do not always have to be money.
Transportation to and from appointments, hotel stays, and rental car costs are other ways to help facilitate clinical trial recruitment outside of simply paying the participant.
In addition, financially compensating or incentivizing recruitment sites also plays an important role. Paying recruiters for performance at sites that adequately enroll study participants can be an excellent way to motivate the study team.
Challenge: Failure To Understand Regulatory Requirements
The United States Food and Drug Association (FDA) has an extensive list of federal regulations that study sponsors must abide by to perform a clinical trial.
Recruitment rules comprise a large percentage of these regulations, so it is vital to understand them before recruiting participants for a study. Failing to adhere to FDA rules can sometimes result in study termination.
How To Prepare
The FDA pledges to be as transparent and communicative as possible to study sponsors while planning a clinical trial. Early and frequent check-in can be very advantageous to ensure a clinical trial is on the right track for successful recruitment.
The FDA also provides guidance on specific recruitment tactics such as media advertising and other methods used to recruit patients. If the study team is not well-versed in federal regulations, sometimes enlisting a CRO can alleviate much of the stress of working with the FDA.
Challenge: Poor Clinical Trial Feasibility
Poor trial feasibility will negatively affect trial recruitment, efficiency, and completion rate.
Site selection, poor 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.
How To Prepare
There are many strategies to improve clinical trial feasibility, such as mathematical modeling, evidence-based feasibility, increasing the number of in-person site visits, developing better recruitment and retention strategies, and refining the site questionnaire.
Quite often, regular check-in and self-assessment during the recruitment phase can prove just as valuable as planning.
Setting benchmarks and periodically self-evaluating can keep a study on track. It can also be beneficial to check specific sites and terminate some early if recruitment is behind schedule.
The Bottom Line
Clinical Research Organizations (CROs) are an invaluable tool to help establish a clear path forward when designing a clinical trial in terms of efficiency and scalability.
While deciding to use a CRO can seem like a significant upfront financial investment, the benefits can be instrumental in ensuring a clinical trial’s success.
Deciding to proceed with a CRO can help navigate some of the most challenging clinical trial obstacles, such as regulatory concerns, protocol refinement, and feasibility issues.
At iProcess Global Research, you can expect to work with the most experienced, exceptional teams while utilizing operations to provide cutting-edge research to help organizations with clinical trials.
Sources:
How to Optimize Patient Recruitment | PMC
Optimizing Clinical Trials Recruitment via Deep Learning | NIH
