Clinical Research Blog Series: Reducing Start-Up Time in Early Clinical Development—Pre-Screening Volunteers
Even though most early clinical development trials only incorporate a limited number of patients as research subjects, subject recruitment can still be challenging for certain protocols. In this clinical research blog, we will introduce a novel approach known as “pre-screening” for making subject recruitment more efficient, producing both time and cost savings and resulting in an optimized Study Start-Up time frame overall.
Implement a Pre-Screening Strategy for Unique Eligibility Requirements
Some early clinical development trials will require that study subjects meet very specific criteria related to laboratory values, genotypes, or other specialized evaluations. In these cases, it is more efficient to conduct only those screening procedures or assessments which are related to those eligibility criteria, wherein only those subjects who meet the stringent criteria will be advanced to more general and time-consuming screening activities.
By doing so, a Phase 1 site can proactively cull-out subjects that would be ineligible based on those criteria and focus their screening efforts only on the best candidates. Additionally, by reducing the number of subjects that would need to be fully screened as per protocol specifications, the site can save both time and costs for the Sponsor.
In order to do this, sites will need to create Informed Consents that are pre-approved by IRBs for use in these scenarios (non-study specific) and administer them in advance of protocol-outlined screening activities.
With careful planning and the availability of quick turnaround times for lab results, some studies may even allow for full screening to occur directly after confirmation that a subject has met the specific criteria being assessed during pre-screening. If you will be exploring the possibility of implementing a pre-screening strategy, discuss these logistics with your Phase 1 site to determine if this a possibility for your study. If possible, this tactic can result in further time and cost savings.
We will complete this clinical research blog series with the next article, which will focus on strategies that can be used to shorten a study’s screening window while still achieving the necessary enrollment numbers.