How a Clinical Trial Liaison Team accelerated Patient Recruitment
A global pharmaceutical company conducted a clinical trial with patients suffering from a rare disease. The successful conclusion of this study on the way to approval of a drug for the treatment of this rare disease was very important for the company. However, the company apprehended that the trial sites could not be able to recruit the required number of patients sufficiently quickly and wanted to minimize the risk of patient recruitment.
Here our team of Clinical Trial Liaisons (CTLs) could help.
In their analysis, the CTLs paid particular attention to whether patients could integrate the study visits well into their normal daily routines and whether they had to go through unpleasant or even painful procedures.
The lumbar punctures, which can be painful and lead to post-functional headache, were identified as a particularly critical point. However, if the doctors used a special cannula type - the ball-point cannula or ball-tip cannula - this could be largely avoided.
Furthermore, the technical guide for a micro scale to be used by the trial sites was difficult to understand. The handling of the scale, however, was actually very simple, once you had tried it and understood its function. There was, however, the risk that the trial sites did not use the scale because of the difficulties to understand the handbook. Therefore a practice-oriented manual was newly developed.
After analysing and solving these two critical points, the Clinical Trial Liaisons visited all sites to discuss the solutions found with the investigators. These talks met with a very positive response. The micro scale was now accepted as study equipment to be used by the study teams. The result of the discussions on lumbar puncture was the launch of an advertising campaign in order to make the advanced methods of lumbar puncture used in the study known within the patient community.
Patients accepted these advertisements very well. As a result, the rate of patient recruitment increased strongly and the recruitment target could be achieved with only marginal delay.
If the Clinical Trial Liaisons team had already been involved in the study planning, these measures could have already been commenced at study start and with high probability the recruitment target would have been reached as planned.