WCCT Global

The success of a Phase 1 clinical trial can come down to how optimally you assign clinical site personnel. Without strategic planning, a study could potentially incur high costs or face other obstacles for trial sponsors. How, then, can you ensure that the staff chosen for your Phase 1 clinical trial units is being assigned correctly to keep costs down and create efficient processes? Here are some tips for evaluating the variables at your clinical trial location. Utilize General Training Each Phase 1 clinical trial unit will have general training and onboarding for new staff. This may consist of reviewing the employee handbook, completing coursework and certification requirements, competency testing before receiving a procedural assignment, ICH (E6) and GCP guidelines, and other types of training. However, what’s most important is that staff are trained for specific procedures in your clinical trial protocol. For optimal efficiency, staff should be familiar with protoco...

When moving to a Phase 1 clinical trial, your company might decide that you want to include a specific population for several reasons. Whether it’s targeting a particular trait for a cohort(s) of the study or the study is using Ethnobridging , you might have more variables to factor into the study than the average Phase 1 clinical trial. Here are some additional participant-related considerations to keep in mind when planning for your clinical trial. Consider the Study Design Are you planning on enrolling the specialty population simultaneously as the general participants? It can be challenging to randomize a full cohort of over 8 participants concurrently in the same way a normal healthy volunteer cohort would be structured. In our experience, allowing for flexibility in scheduling confinement and follow-up visits can be beneficial and attractive to patients and in turn make the study easier to enroll. If the specialty population cohort won’t be enrolled until all NHV cohorts have b...