These days, if a CRO offers to run a global antibiotic clinical trial without presenting a network of qualified and trained microbiology labs, the sponsor should be suspicious.
These days, if sponsors don’t see clear metrics from a CRO on isolates identification rates in, lets’s say, CABP or ABSSSI compared to standard routine rates of isolate identification by microbiology labs, the sponsor should be suspicious.
These days, if sponsors don’t receive straightforward examples of consistent on-time delivery of antibiotic trials, with references from fellow sponsors, they should be suspicious.
How many months of enrollment were assumed from FPI to LPI in previous studies in the discussed indication? What actually happened? That timeline should be similar, with a deviation of no more than 10% in both directions. Consistently, time after time.
How many sites were initiated and how many remained inactive, per region?
Eyes on Microbiology Labs
Microbiology assessments produce key parameters in antimicrobial studies validating trial endpoints and outcomes. How micro labs will function around the world in your pivotal trial is a key question that any sponsor needs to get to the bottom of when selecting a CRO. So just keep digging deeper.
For microbiological confirmation (the so-called MITT population):
- How do you plan to provide a sufficient level of pathogen identification to meet the FDA and EMA requirements?
- How will you ensure collection of a necessary variety of pathogens, including typical and atypical pathogens, both aerobes and anaerobes, effective isolation from mono- and mixed cultures, causing the specific infection?
- How will you ensure collection of pathogens with different and representative antibacterial resistance patterns (for example, specific to each involved geographical region or even a particular hospital)?
- For a cUTI trial, how will you ensure standardization of pathogen quantification across different sites and laboratories?
- For a CABP trial, how will you ensure minimal time between sample collection and culturing, especially for pathogens (e.g., pneumococcus) that can only survive for a short time post sampling?
- For an ABSSSI or Septicemia trials, how will you ensure that the laboratory identifies anaerobic pathogens correctly?
These are important questions to make sure complex microbiology assessments are addressed with the necessary level of attention by the CRO’s microbiology experts (and an antibiotic-focused CRO should have those on staff). Without this deeper understanding and level of expertise, you run the risk of many roadblocks along the way.
After all, the success of your study largely hinges on the success of the microbiology arrangement. Be sure to thoroughly evaluate it.