April 14, 2016
Patient recruitment – A critical factor in your clinical trial
During a clinical trial, it is important, that patient recruitment will progress as anticipated and in accordance with predefined timelines. Involved investigators often know or have a list available with potential subjects who may be interested in participation, which can result in a good enrollment start. However, once these (pre-listed) subjects have been contacted and, when interested, screened, a drop in the inclusion rate could be faced. Such a delay in the enrollment rate may endanger your timelines, which could result in an extended trial length, delayed market entry with associated costs.
In a clinical trial one has to deal with strict predefined inclusion and exclusion criteria, looking for an eligible subject in a selective patient group. Besides that, not all potentially eligible subjects are willing to participate in a clinical trial. Therefore, it is may be valuable to assist your sites with recruitment and to look for options to boost enrollment. For example, using social media, newspaper advertisements, radio commercials, etc.
The most appropriate recruitment method will depend on the target population, specific trial requirements, and the time you have for completion of enrollment. For instance, a radio commercial or newspaper advertisement might be more valuable compared to the use of a Facebook banner when you are looking for an elderly population. The implementation costs differ per strategy, but also the average response time of potential subjects varies. So it is good to examine the different possibilities and define what would be the best enrollment strategy for your trial.
Another key factor in the recruitment process are your (potential) sites. Before study start they may have provided an estimation of subjects numbers they expect to enroll. If they overestimate the amount, you risk that anticipated target numbers and timelines might not be reached. Obtaining realistic expectations on forehand is therefore essential. Besides, the sites need to have the time and staff available. You can help your sites to boost the recruitment and reaching potential subjects, but a good follow-up of interested subjects is essential.
Recommendation: Patient recruitment plays a crucial role in your clinical trial. Consider exploring the different recruitment methods while planning your study. An investment that can pay back in later stages of the trial! Start sooner – Finish faster.
By Marije Moek