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Drug Testing and Safety
Drug testing as part of clinical trials is an exhaustive process and one that bears consistent examination. There are clearly some barriers to effectiveness that need to be addressed: according to research by AstraZeneca, 60% of project closures in drug discovery between 2008 and 2012 were safety related. This data comes from Dr Will Redfern, Associate Director of the Cardiovascular and CNS Translational Centre of Expertise at AstraZeneca, who was kind enough to speak at our recent webinar with Inside Scientific.
The problems with testing the safety of drugs in the pre-clinical stage do not arise from negligence: they come from a lack of ability to correctly identify safety signals. According to Dr Redfern, one of the major shortcomings that impede the early and effective elimination of potentially unsafe drugs is a lack of safety hazard detection in the pre-clinical stages. Compounds that are “doomed” make their way into clinical development and are not removed until much later.
According to Dr Redfern and AstraZeneca, central nervous system (CNS) symptoms comprise the biggest safety factor that takes drugs out of development in the clinical stages. Unfortunately, they are also the hardest to detect in the pre-clinical phase.
This inability to remove unsafe compounds early costs drug companies billions, and severely hinders progress when it comes to getting safe, effective drugs to patients. If “doomed” compounds can be taken out of the running earlier, clinical trials will become more effective and the drug discovery process will become much quicker and smoother.
Actual Analytics offers companies the chance to tackle the lack of preclinical detection of unsafe compounds. The main problem with detecting CNS symptoms at the preclinical phase is that rodents have no way of communicating when they experience them. As we discussed last week, mice and rats do display telltale signs of issues like neurobehavioural conditions, but they are hard to spot using traditional methods like the Irwin Test or functional observational battery.
As Dr Redfern points out in our webinar, being able to test factors like locomotor activity without distressing the rodent makes a huge difference. Being able to pick up on abnormal behaviours quickly is another huge advantage that is held back by standard procedures (such as wading through hours of video footage looking for behaviours).
ActualHCA offers researchers the ability to monitor for these symptoms 24/7 and pick up on them before the study has progressed too far. The software is annotated to pick up on and flag unusual behaviour, so 24/7 recording does not have to mean 24/7 viewing. The indicators that signal CNS symptoms can be detected quickly with ActualHCA, meaning fewer unsafe compounds make it to the clinical stage.