It’s becoming more and more common for Sponsors and CROs to establish shortlists or preferred providers, even for Clinical Phase 1 Units. When this happens, the site selection and site qualification process is expedited significantly, meaning that study start-up can take place more swiftly. Because time reductions are so important in clinical development, it’s no wonder that more Sponsors and CROs are turning to this practice.
However, by taking this approach to site selection, Sponsors and CROs can overlook some key factors regarding their clinical Phase 1 units’ capabilities and operations. While the “preferred provider” approach can be helpful and save time, Sponsors and CROs should still be asking some targeted questions to ensure that their pre-selected Phase 1 sites can execute the specific study under discussion. We have come up with a list of ten of these questions.
10 Questions to Ask Clinical Phase 1 Units
No two studies are ever quite the same. There is a great deal of variation, both large and small, that can significantly impact study conduct as well as impact a Phase 1 site’s ability to successfully perform the study as outlined in the protocol. When using preferred sites, Sponsors and CROs can afford to breeze through most of the basic information during site selection and qualification, but shouldn’t neglect to ask these important questions:
1. Has your team developed an optimal plan to conduct the study that is specific to the protocol?
Some sites may simply look at basic information such as the number of subjects, visits, and procedures, and develop a high-level plan for conduct. Instead, you should ensure that sites have evaluated the protocol in detail and developed a plan that is specific to its requirements. Here is an example of the type of feedback sites should give, showing critical review of required assessments, assumptions made, and points of clarification.
2. What are the staffing needs for this protocol?
In many cases, clinical Phase 1 units will apply blanket assumptions for study conduct without considering the different levels of resourcing that is necessary for a specific protocol. This can lead to improper staffing, increased costs, and significant risk for subject safety. Here is an example of a master procedure of events that sites should produce, demonstrating that they have thought through the “stagger” of assessments and resourcing requirements.[Read this blog for some suggestions on decreasing costs of Phase 1 trials]
3. What is the process for maintaining your site’s volunteer database?
Sponsors should have a clear understanding of how a site maintains their database of volunteers. Request information such as how often the database metrics are updated, what type of system is used to run queries and reports (for feasibility purposes), and how the data is segmented. Obtaining this information will provide insight into how quickly and efficiently a site will be able to recruit for your study.
4. What measures is your site taking to minimize risks during clinical conduct?
Protocol deviations can pose potentially serious threats to the overall success of a Phase 1 clinical trial. This being the case, sites should be doing all they can to prevent these risks before they occur. This involves a detailed analysis of the protocol and top-level insight from all who will be involved with the study. Ask your sites about their policy or SOP on Risk Management Planning, to understand how they Identify, Evaluate, Control, Communicate, Review, and Report risks. [Learn more about our approach to Risk Mitigation in Phase 1 Trials]
5. Should a protocol deviation occur, what steps will your staff take to resolve the issue?
In some cases, deviations aren’t preventable. When they occur, clear guidance for resolving those deviations is required. Your Phase 1 sites should have a response plan assigned to as many deviations as possible, to prevent any serious repercussions for your study.
6. Are there any special considerations which need to be made regarding vendors or supply chain?
You’ll want to ensure that not only the site, but the vendors they choose for the study, can handle the risks associated with the study and that vendors are versed on how to handle specific situations that could arise during study conduct. For vendors that contribute to critical process or trial data, consider asking your site for a joint meeting with the vendor to talk through such risks. This can happen during the Site Qualification and/or Bid Defense processes.
7. Have vendors been adequately assessed by qualified site personnel? Just because a site has sent personnel to inspect the vendor, the personnel themselves may not know what’s needed from the vendor if they aren’t qualified to handle the inspection. Ask your sites about their policy or SOP on vendor selection and qualification. Additionally, you’ll want to examine that site’s previous experience with that vendor.
8. How are various functional areas of the trial managed?
Does the site utilize staff that may or may not have expertise in overseeing certain functional areas (e.g. assigning the same staff to both Screening activities and Data Entry)? Or, can you expect that the personnel in charge of performing certain tasks will instead be dedicated to those functional areas and thus will not need be required to split their focus? In this model, it is imperative that the site also assigns personnel to coordinate cross-departmental staff to support the Primary Investigator. There is no “right answer” to how the different functional areas are covered, but it is important to know how a site operates before selecting a site for your trial.
9. Have site staff been trained to execute the specific procedures as outlined in the protocol? If not, how will training be handled prior to clinical conduct?
Research and medicine aren’t the same. If the site’s staff have experience with procedures, but not in a research setting, this could negatively affect your study. If the staff isn’t trained to do the procedure, the site will need to have a clear training program to ensure that the staff can conduct the procedure effectively and within the requirements of the protocol.
10. Does your site contain all the necessary equipment to conduct the specific procedures or assessments outlined in the protocol?
If the site has the necessary equipment to conduct the specific procedures and has worked with the equipment extensively in the past, you probably won’t have anything to worry about. However, if the unit needs to rent the equipment, the staff may not be familiar with how to operate it, necessitating training and posing a potential risk to your study due to inexperience with both the staff and a potential vendor. Ask your site to explain how they will manage this.
Asking these simple questions of your clinical phase 1 units before selecting them as a study location can go a long way to improving the safety, quality, and overall success of your Phase 1 program. Consider having these detailed discussions with your current and prospective sites during your next selection and qualification process.