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What is Considered Basic Safety Testing these Days?

Posted by Kathy Murray, August 23, 2010, 2:36 AM

I want to open the discussion of what we now consider “basic safety testing.” With increasingly complex protocols and regulations comes an inevitable evolution in what we consider this term to mean. I’ll preface this discussion with a brief synopsis of obvious advancements I’ve seen, and would enjoy hearing about your observations over time in regards to this subject.

It used to be that performing the main concentrations of basic safety testing, bio-chemistry, hematology, coagulation and urinalysis testing encompassed industry standards to ensure no clinically significant variations from baseline were due to the pharmacodynamic of the study article.

However, ACM Global is now addressing the shifting focus to more esoteric exploratory essays. Protocols are now including more esoteric and molecular based assays. The use of our multiplexing instrumentation and increased utilization of flow cytometry is serving to address the evolving identification of biomarkers to aid in the treatment and tracking of disease progression. We are adding new markers to our test menu on a regular basis in response to this focus on esoteric biomarkers from our clinical trial clients.

Yet we have encountered sponsors that are still requesting gold-standard assays found in dated literature, which in many cases are archaic and often no longer offered on standard laboratory platforms. These assays have since been replaced by more sensitive, reproducible and economical assays on automated platforms, which offer standardization and improved turn around time.

Therefore, we see the role of central labs evolving to collaborate with sponsors and adjust expectations to keep in line with new assays. The use of automated platforms has also had an impact on what is now considered basic safety testing. What were once considered esoteric testing, for example PSA and CRP, have now become routine for certain indications. This allows the lab to provide advanced basic safety testing, which of course, is always in the best interest of the sponsor and their subjects.

So the question is, what is considered basic safety testing?

Please let us know what you consider as basic safety testing and other changes in industry standards that you’ve observed. Join the discussion by leaving your comments below.

Category: Clinical Trials Testing