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 is everything 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 CRO’s should still be asking some targeted questions to ensure that their pre-selected Phase 1 sites are capable of conducting the specific study in question. 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 exactly the same. There are a great deal of variations, large and small, that can significantly impact study conduct as well as effect a Phase 1 site’s ability to successful 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 patients, 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.
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 patient safety.
3. When was the last time your staff optimization model/algorithm was updated? Phase 1 units should strive to constantly improve the overall efficiency of their personnel. This can be accomplished by monitoring the activity of specific positions, and then aligning the correct number of employees with the forecasted activity. Sites should be re-evaluating this fairly frequently, to ensure that they are assigning the best staff possible to handle clinical conduct.
4. What measures is your site taking to minimize risks during clinical conduct? 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.
5. Should a deviation occur, what steps will your staff take to resolve the issue? In some cases, deviations aren’t preventable. In those cases, clear guidance for resolving those deviations is required. Your Phase 1 sites should have a response plan assigned to every possible deviation that could occur, 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, are capable of handling the risks associated with the study and that vendors are versed on how to handle specific situations that could arise during study conduct.
7. Have vendors been adequately qualified by qualified personnel? Just because a site has sent an auditor to inspect the vendor, the auditor themselves may not know what’s needed from the vendor if they aren’t qualified to handle the inspection. Additionally, you’ll want to examine that person’s previous experience with that vendor and the results from previous studies.
8. What does the escalation tree look like between the site and vendors in the event that there are issues which need to be resolved quickly? Should a deviation occur, there should be clear steps to resolve the deviation and a clear delineation of responsibilities between the site and the vendor and the response should be clearly identified.
9. Has 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 exactly 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 safely. However, an inexperienced staff may result in less-than quality results.
10. Does your site contain all of the necessary equipment to conduct the specific procedures 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.
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.