Clinical trial success is greatly dependent on patient recruitment success.
50% of all randomized control trials (RCTs) fail to meet their recruitment goals.
However, the actual statistics may be slightly worse than that.
A review of 41 RCTs listed in the National Institute of Health’s 1979 inventory shows that only 34% reached1 their recruitment goals with a staggering 66% failing to do so.
Recruitment issues can arise for many different reasons but without proper analysis it is hard to prevent them from recurring in subsequent studies and even more difficult to correct in real-time.
In all honesty, there is little that can be done regarding study design by the time you are responsible for the success of managing it, but the impacts of a poorly designed study can be numerous and usually quite visible in overall study recruitment.
Recruitment depends on a voluntary desire for study participation. When study procedures occur in an inefficient manner, it often leads to frequent and/or lengthy clinic visits. This can make study participation less desirable which will greatly affect enrollment.
That is why it is critically important to focus on both what needs to occur during the study as well as what any one person will have to endure during the life of the study. It is a delicate balancing act that can be crucial to the overall recruitment. Having the ability to see where challenges may have derived, (easily accomplished with the use of recruitment analysis), can be invaluable in showing your due diligence during ‘lessons learned’ meetings.
Even when a study is well designed, there could still be challenges faced when it comes to enrollment. Precision is required in order to identify the target patient population for any study. However, having inclusion criteria that is too narrow or having wide exclusionary criteria can greatly limit the number of qualifying people available for study participation.
Site selection is another area that could have a direct impact on recruitment. During the feasibility phase, properly assessing which locations have the greatest chance for serving the target population becomes integral. This is not to say that all sites should be in heavily congested areas. Nevertheless, Study Managers should consider whether sites are reasonably accessible to the desired patient population.
Trials360 simplifies the tracking of enrollment allowing you to address these challenges as they present themselves.
Sometimes the problem may simply be that recruitment methods are not varied enough. Sites may solely rely on centralized recruiting provided by the study-chosen vendor. Centralized recruiting is great for casting a wide net when it comes to finding a large amount of possible study participants, but it generally produces a smaller number of actual qualified candidates. This is because centralized recruiting tends to use a narrow version of the full eligibility criteria during pre-screening.
Once these possible study participants have their screening visit, unfortunately many of them do not qualify for the study. Due to past experiences with centralized recruitment efforts, some sites will solely rely on doing a pre-screening review of their current patient database. This method is good for finding possible study participants that are more likely to qualify for and be willing to enroll in the study.
Yet, it greatly limits overall enrollment to just the patients with which you are already familiar. When sites go this route, study recruitment comes to a halt once they have exhausted their patient database options.
It is not always easy to identify the many possible recruitment pitfalls prior to the start of a study. Sometimes the answer to these challenges is best addressed in real-time or by looking into what went right in past trials that met their recruitment goals.
Recruitment analysis helps by highlighting relevant patterns that can be beneficial for redirecting efforts. Active tracking and analysis of study recruitment via Trials360 can help by providing real-time data for solutions to recruitment challenges.
Trials360 solutions are efficient and are custom fit so that they can be combined with your existing operations. Using advanced analytics can both reduce costs associated with clinical trials and save time.
Let Trials360 take recruitment analysis off your To-Do list so that you can focus your time and efforts elsewhere. Click below to learn more about Trials360: