Clinical Research Blog Series: Reducing Start-Up Time in Early Clinical Development—Reducing the Screening Window
Most early clinical development protocols utilize a standard 28-day screening window to identify eligible subjects to be enrolled in the first cohort of the trial. In this clinical research blog, we will focus on the ways in which this initial screening period can be reduced for the first and subsequent cohorts.
Reduce the Screening Window
Below are some methods which Phase 1 sites can utilize in order to truncate the screening window in order to conduct dosing of the first cohort on an earlier date, which will also impact the timeframe in which subsequent cohorts begin:
- Create a Subject Waitlist: If a site maintains a large database of available and interested research volunteers, that database can be filtered for high-level parameters based on eligibility requirements. Then, instead of sifting through indiscriminately, the site can proceed with a targeted approach to recruitment activities as soon as the study has been approved by the IRB.
- Implement a Large Screening Effort: Since this tactic may be limited to Phase 1 sites that are larger and with access to a larger staff pool, it is valuable to keep this capability in mind during the selection process. Sites that can regularly screen up to 50 subjects a day will obviously be able to identify subjects faster than sites that are limited to lower numbers. The ability to do so not only requires a larger staff pool, but also that the time needed to screen any one individual can be optimized as much as possible. This can be done by assigning the individual tasks involved in the screening visit across multiple staff. Finally, sites can screen more potential subjects if they maintain flexible hours for screening or are even available to perform screening weekends.
- Ensure Quick TAT for Lab Results: Make certain that your Phase 1 studies are being conducted at sites which maintain streamlined relationships with local labs, or (ideally), operate a lab on-site. The ability to obtain lab results for standard early phase protocols within 24 hours or less will be crucial in the site’s ability to not only screen potential subjects, but quickly clear them for enrollment.
In our experience, if the above strategies are implemented, the screening window for many early clinical development projects can be reduced by half or more in some cases. We hope that this clinical research blog series on reducing Start-Up timelines has been insightful and that you will utilize these tactics when planning your next Phase 1 trial.
Clinical Research Blog Series: Reducing Start-Up Time in Early Clinical Development
In this clinical research blog series, we will focus on how Sponsors can reduce start-up timelines in Phase 1 trials through various creative tactics. The first of these strategies is to utilize a Start-Up Agreement (or contract).
Functional and Flexible Staffing
In this blog, we will highlight some traits that Sponsors can look for at study sites which are likely to optimize the time needed for Study Start-up. One such characteristic is a site that maintains both functional and flexible staff to perform tasks related to IRB submissions.
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.