phase 1 clinical trial unit

To review, there are a number of standard criteria which Sponsors and CROs look for when evaluating a current or prospective Phase 1 clinical trial unit and determining its ability to conduct a large Phase 1 clinical trial. These criteria are:

  • Experience of the PI and Nursing Staff
  • Bed space
  • Access to the patient population
  • Access to necessary equipment
  • Experience in similar studies
  • Geographic location
  • Enrollment capability
  • Regulatory history
  • Contract/Budget negotiation structure
  • Overall costs

While these items are important for selecting the correct Phase 1 clinical trial unit, only evaluating these standard criteria can leave Sponsors and CROs with less-than ideal sites to take on their early clinical development projects. By overlooking a few critical factors, Sponsors and CROs can end up paying far more than they should be, as well as put their study at higher risk for failure and adverse events due to shortcomings in training, experience, quality of staff, and vendor usage. But what are these critical factors?

Critical Factors for Selecting a Phase 1 Clinical Trial Unit

1. Internal costing exercises: Sponsors and CROs will want to make sure that their current and prospective clinical Phase 1 units are assessing procedural and staffing fees to come up with an appropriate fair market value. If sites are not researching fair market value to find the price points at which an agreement can be made, value cannot be passed along to Sponsors. Additionally, there are some protocol specific considerations involved, such as determining the number of cohorts necessary to efficiently run the study.

2. Staff optimization: Are sites using updated algorithms in order to align the correct number of staff with the forecasted daily activity of the unit? Furthermore, has the Phase 1 clinical trial unit compared its forecasted activity for other studies against the forecasted activity for your study and looked for ways to remove redundancies, increase efficiency, and ensure that there is no congestion of staff or patients which could cause unnecessary risks to occur? It is typical for Phase 1 units to apply blanket assumptions to budgets and not consider how different types of studies will require different levels of resourcing, so this exercise can be complex. Overall, sites should be assessing the overall efficiency of their personnel.

3. Risk mitigation and contingency planning: Does the Phase 1 clinical trial unit have a clear plan for preventing adverse events and deviations during clinical conduct? Furthermore, should they occur, does the site have guidelines for responding to these issues in a timely fashion without jeopardizing the overall study? Involved in these measures are ensuring patient safety, which should be paramount during all stages of study planning and conduct.

4. Vendor usage and selection: By taking a close look at the relationship between the site and its vendors, Sponsors can ensure that key study components aren’t overlooked and internal deadlines aren’t missed due to poor management or selection of vendors. Has the site qualified its vendors? Was the qualification conducted by someone who is actually qualified to do so? Will additional time need to be spent to train vendors due to the specifics of the protocol, or are they already familiar with key study components and requirements? Evaluating these factors can help Sponsors determine whether the site should manage vendors at all or if vendor management and selection will need to be done in-house, which can be burdensome.

5. Ability to execute complex procedures: Research and medicine are not necessarily the same. While a procedure may be the same and the physician can do it in the same way, there may be aspects that need to be considered uniquely for clinical studies. It is imperative that Sponsors are clear on whether or not the key staff at a Phase 1 clinical trial site are trained do execute procedures and are informed on whether the staff has performed the procedure in a clinical setting only or for research. Additionally, the site should have a clear understanding of the risks associated with the procedure and be able to mitigate those risks. Lastly, there will be multiple ways in which a complex procedure can be performed, but does the Phase 1 site plan on doing it in the most effective way for the protocol?

By evaluating these critical factors, Sponsors and CROs can make better decisions when selecting a new Phase 1 clinical unit or re-assessing their current list of preferred providers.