After being in the draft stages for approximately three years and continuing to receive industry feedback, the FDA CDER has just released final Guidance for Industry Title Testicular Toxicity: Evaluation During Drug Development in October 2018. There are numerous challenges with conducting multi-center clinical trials focusing on testicular toxicity and yet remaining within the realm of guidance from the FDA per their statement:
"A single central laboratory should process and analyze all semen samples for the purposes of consistency and quality assurance."
The primary challenge with this is the stability of semen specimens themselves (<1 hour), as well as the lack of trained semen analysis technologists/andrologists at clinical trial sites and significant inter-laboratory, as well as intra-laboratory variability with processes and procedures.
Eurofins Central Laboratory has been providing the industry a solution to these challenges for over three years now with our Mobile Laboratory Technician service offering. This allows our clients a pathway for compliance with the FDA Guidance document, by having certified Eurofins Laboratory Technicians perform standardized and qualified semen analysis within the stability time window, at sites located globally.
But first, let's explore the significant elements of the final Guidance Document surrounding Testicular Toxicity.
The FDA has highlighted the following outcomes in nonclinical trials, that would increase the likelihood of testicular toxicity monitoring in the clinical phase protocols:
If any of the above mentioned criteria are observed during nonclinical phases, the FDA Guidance document recommends the following for clinical phase study design:
To overcome the challenges with limited specimen stability, lack of qualified semen analysis technicians at majority of clinical trial sites and significant variability with both inter- and intra-site laboratory results, Eurofins Central Laboratory has been providing our Mobile Laboratory Technician solution to the industry. Emulating the CRA model abundant within the clinical trial industry, we have built a department of Mobile Laboratory Technicians (MLT) that are available on-call for those patients wth upcoming screening visits for baseline analysis, as well as the planned follow-up visits during week 13 and end-of-drug treatment. Our dedicated MLTs bring the standardized and certified analysis required by the FDA, to each of your clinical site locations globally via our staffed locations in:
Licensed and certified Laboratory Technicians worldwide
Performs standardized analysis at clinical trial site, under Eurofins CAP/CLIA certifications from our four global locations
Includes CAP/CLIA required oversight from Eurofins Laboratory Supervisor, Director and Medical Director ensuring submission ready data results
Proficiency testing at defined intervals based upon Sponsor criteria
Travels with calibrated equipment to each clinical site, reducing costs for hardware placement and calibration at each clinical site globally
To learn more about our Mobile Laboratory Technician solution for short stability specimen analysis (semen, PBMC processing), please reach out to our scientific team here and we can explore your requirements and Eurofins Central Laboratory solutions together.