The success or failure of a clinical trial hinges on many factors, but one of the most critical is patient recruitment. According to research, an incredible 85% of clinical trials fail to meet their recruitment goals – putting study data quality and development timelines at risk. Inefficient trial recruitment efforts can add almost 11 months of delays for late-stage trials, driving up operational costs and delaying time to market.
Knowing that robust patient recruitment contributes to the development of better drugs and better options for patients, how can pharmaceutical organizations improve patient recruitment in clinical trials? And how can technology make the recruitment process even easier?
Why is clinical trial recruitment important?
Recruitment and enrollment are time-consuming – so much so that these activities often cause missed trial deadlines. According to the National Center for Biotechnology Information:
“Insufficient or untimely patient recruitment into [randomized clinical trials] has serious consequences. The trial length may need to be extended, increasing resource use and costs. Lengthy trials delay the availability of potentially beneficial treatments to the public. The integrity and validity of the study also rely on adequate sample size. If the sample size is not achieved, there is an increased chance of committing a type II error (e.g., you are more likely to find no difference between treatments when one actually exists). The trial may have to be abandoned, and the results may not be publishable.”
Improving patient recruitment is one way that pharmaceutical companies can avoid such costly delays and accelerate the time to market for new drugs. For safety reasons, the drug development process includes clinical trials that take place over four phases, each with a different purpose:
- Phase I trials typically include 20 to 80 healthy volunteers to test the drug’s safety and side effects and determine the proper dosage
- Phase II trials include 100 to 300 people who have the disease or condition the drug is designed to treat, to test the medication’s efficacy
- Phase III trials are done with a large group of people (300 to 3,000) for further safety and efficacy testing
- Phase IV trials are conducted once the drug obtains FDA approval and typically include several thousand volunteers from diverse populations who have the condition or disease
Even when executed perfectly, this process can still take several years to complete.
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Why do studies fail to hit their recruitment targets?
There are numerous reasons why studies might fail to hit their recruitment targets. A recent study published in the National Library of Medicine identified 29 different reasons for recruitment failure. Chief among those reasons is poor engagement among trial sites, recruiters, and trial teams:
“Many interviewees had encountered challenging collaborations with colleagues from their own department, other departments within the hospital or other hospitals, which significantly affected their ability to recruit trial participants. They also described the perceived hierarchical relationships among various health care professionals as well as ambition and ego of individuals which prevented trial implementation as planned.” – Briel, Elger, et al
This study makes it clear that effectively engaging trial sites, teams, and recruiters is essential if a study is to meet its recruitment goals, and ultimately prove successful.
How can pharma companies improve patient recruitment?
Effective trial recruitment is difficult, but as we’ve seen, failure to recruit effectively can result in costly delays or even outright failure. However, many Within3 clients optimize their recruitment efforts through the Within3 insights management platform.
One global pharmaceutical organization was looking to recruit 700 patients for a phase-3 randomized breast cancer trial slated to run across multiple countries simultaneously. The client company saw this trial as an opportunity to improve outcomes for patients with hormone receptor-positive HER2-negative breast cancer – the most common form of the disease.
Breast cancer is a historically challenging area for patient recruitment. Resource scarcity, patient concerns around side effects, and lack of awareness of trial opportunities contribute to lower than average recruitment rates. According to a recent study published in BMC Women’s Health, just 2–3 % of all breast cancer patients participate in clinical trials throughout the course of their treatment.
The client wanted to tackle one of the primary reasons for recruitment failure: poor site engagement. Using the Within3 insights management platform’s virtual asynchronous engagement capabilities, the client team could quickly train and onboard sites across multiple locations. Live and in-platform translation functionality meant that all participants could engage in their native language asynchronously, at a time and place that worked for them.
By ensuring trial sites were well trained and properly engaged, our client not only met their recruitment targets but did so earlier than expected. Since 85% of clinical trials fail to meet their recruitment goals, what the client team achieved via the Within3 platform was nothing short of remarkable.