Clinical trials are inherently complex undertakings, and external factors can derail them. Not only are 80% of all timeline delays for an ongoing study attributed to recruitment difficulties, but 85% of trials overall fall short of their recruitment targets. However, it is possible to prepare solutions for these challenges from the beginning to minimize their negative impact on your project. We’ll explain how patient enrollment can affect a clinical trial and provide four key strategies to avoid missing your clinical trial patient enrollment goals.
How Patient Enrollment Can Affect a Clinical Trial
Randomized clinical trials are a gold standard for providing evidence-based research, particularly in the medical field. However, the value of the data generated from these studies directly depends on effectively meeting expected recruitment goals. Insufficient patient numbers carry serious implications, which can lead to the early closure of the study.
Slow enrollment requires the study to be open for longer than expected, which increases its cost in both time and materials for the sponsor. More importantly, if the required sample sizes are not reached, the resulting data becomes compromised because there is an increased chance of failing to detect existing statistically significant conclusions, also known as a type II error.
Researching and understanding how to meet patient enrollment targets adequately will better protect your trial from these massive implications before it even begins. Here are our top four foolproof strategies for keeping your patient enrollment goals on track.
1. Have a Strong Site Network
The first point to keep in mind when building your trial is to select the right clinical research sites. Although the sponsor is ultimately responsible for a study’s outcome, the quality of their enrollment and data hinge upon choosing the best sites. Trials that exceed performance expectations are comprised of sites sufficiently equipped with relevant experience, skilled and trained staff, and appropriate patient pools.
Devoting proper attention during the feasibility stage can save sponsors time and money down the road when their chosen sites can generate the required volume of patient recruitment. The site start-up process is also costly for the company; therefore, developing a strong network from the start is essential for meeting key goals.
2. Be Patient Centric From Start to Finish
Patient centricity is an approach that incorporates in the trial design the needs and perspectives of human patients participating in the clinical trial. Often, study protocols can be complicated and demanding for subjects, resulting in poor patient retention throughout the clinical trial.
One method of reducing drop-out rates is utilizing an easy-to-use U.S.-based call center that provides essential trial information for interested patients and efficiently conducts screening for the best candidates.
Additionally, sponsors can also develop materials, such as brochures or pamphlets, to provide patients as a way to keep them informed on every stage during a trial. Overall, incorporating patient-centric strategies help individuals understand these studies better and facilitate more substantial relationships with site staff. They also improve follow-up communication with patients, especially with assistance from relevant automated tools.
3. Use Multi-Channel Strategies Backed by Powerful Technology
The right technology can change everything for a trial, from streamlining management processes to simplifying patient communications. AI-assisted pre-screening or tech-enabled screening products can select potential candidates more quickly than manual data mining, saving sites valuable time.
Innovative CROs like Vial also provide dedicated recruitment platforms, various marketing campaigns, and smart filtering for a site’s existing EMR. These tools assist with selecting appropriate subjects and allow for hyper-specific demographic targeting to reach motivated patient subjects from diverse backgrounds.
4. Create Realistic Trial Plans & Timelines
Most trials overestimate their enrollment projections, as they are developed based on best-case scenarios. However, conducting clinical studies naturally lends itself to many pitfalls which may delay its timeline.
Sponsors must take care not to move too quickly through study start-ups, as significant planning gaps become apparent later on and can ultimately result in missing patient enrollment goals. Successful recruitment efforts start with creating a trial plan that incorporates an honest, patient-centric study design, realistic timelines with conservative patient number estimates for sites, and clear, organized project management goals.
Finding the right people for your clinical trial can be a challenge. Still, sponsors can minimize the obstacles they may face by taking the time to establish a quality site network, adopting a patient-centric approach supplemented by the right technology, and creating realistic plans.
The Vial CRO is steadfast in discovering & testing the most effective and efficient combination of strategies that works for its sponsors. Our services and products step outside the box of traditional methods to provide sponsors access to a broader subject population. Connect with a team member today to discover how we can help you meet your clinical trial patient enrollment goals!