The Dilemma of Patient Recruitment
Do you know this? You as the sponsor have invested a great deal of time and effort in the preparation of a clinical study. The feasibility analysis delivered good results, the investigational sites are initiated, but patient recruitment doesn’t get off the ground?
Patient recruitment shapes up as shown in the graphic below. Your trial sites recruit only a few patients, and before you know where you are the first months have gone by. After quite a few web conferences with your monitors and the investigators you decide to issue an amendment to the clinical trial protocol, to overcome the apparent difficulties in patient recruitment. Until the amendment is approved and implemented at the trial sites another two months pass by. Subsequently patient recruitment rises slightly, but still stays significantly behind your expectations.
In the discussions with the investigators additional obstacles come to light which up to now haven’t been an issue. Now they do! You conclude to move forward with another amendment and again you lose valuable time until the amendment is approved and implemented. Indeed patient recruitment gathers pace now, but you realize that you will reach the case number required for the study presumably 12 months later than initially planned.
It doesn’t have to be that way! Our Clinical Trial Liaisons (CTLs) help you to identify the challenges for your clinical study early on, to select the trial sites matching your study, and to support the investigators and their study teams in a way that they are highly motivate to work on your study.
Thereby significant savings in time and costs can be achieved compared to constraining to pure monitoring of the trial sites. Because the delays in clinical studies cost a lot of money because the entire study logistics must be maintained during this time and additional monitoring visits are required.
As shown in the table below for the example of a neurological Phase III study with 375 patients at 42 sites in three countries and a duration of 31 months, additional costs of 39.5% emerged, which could have been avoided with a combination of monitoring and clinical trial liaison. Compared to the original monitoring plan, even a slight cost reduction of 3.4% could have been achieved. This result delivers calculating the study costs with our budget calculator.
Potential additional turnovers and profits through an earlier market launch and a better utilisation of the remaining patent term of your medication or medical product are not yet taken into account.
|Concept of Clinical Trial Site Management||Share|
|Monitoring incl. feasibility analysis and site management as originally planned||100,0%|
|Monitoring incl. feasibility analysis and site management delayed by 1 year||139,5%|
|Clinical trial liaison incl. feasibility analysis and site management||32,5%|
|Monitoring excl. feasibility analysis and site management||64,1%|
|Clinical trial liaison plus monitoring||96,6%|
|Concept of Clinical Trial Site Management and their Costs|