lecture 22 Flashcards
What are the two key questions in clinical pharmacology and how might they be answered?
Is this drug effective when compared to controls and alternative medications? This can be answered through compounds being tested against drug libraries of already existing drugs
Is this drug safe? This can be tested through clinical trials
What are the key steps in clinical trials and how do they relate to testing if a drug is safe?
Phase 0 is testing to predict how the drug will act in humans
Phase 1 is testing the tolerability of the drug
Phase 2 is testing the effectiveness of the drug against placebos
Phase 3 is testing safety
Phase 4 is post marketing monitoring
What are the two type of drug treatments and where do they act in the disease process?
Disease modifying drugs which aim to reduce the pathology of the disease to prevent it from progressing
Symptomatic drugs such as pain releave whic do not influence the pathology but instead try to treat the effects of the pathology
What is a biomarker?
A readily measurable marker that reflects an important feature of the disease, and therefore reliable show biological responses to drugs for example tumour size
Not the same as a therapeutic response which is how the patient feels
What is an a surrogate endpoint and why are they useful?
A surrogate endpoint is a biomarker which is not an outcome (like a stroke or death) but is supposedly closely related to the disease and therefore are able to be used to reflect the eventual clinical outcomes. These are useful as they allow for faster, cheaper and easier clinical trials as outcomes which may take a long time to develop are not needed to be measured
What are the features of biomarkers?
Repeated measurements are possible usually cheap often give high content information often give a rapid indication of response can be of prognostic or diagnostic value
What are the features of clinical out comes when measuring drug response?
They are subjective Often may happen only once Can frequently be only one binary digit (eg death vs survival) May take a long time to develop Provide low amounts of information
What are the potential problems with biomarkers?
Surrogate endpoints may not always be accurate of clinical outcomes for example blood pressure lowering is predictable however it rarely predicts individual beneficial clinical outcome this occurs as Disease processes are complex, and outcomes are subjected to many variable which may not always be appropriately reflected through measurement of a simple biomarker
Why can generic drugs avoid going through a full scale clinical trial process?
Drug concentration can be used as a surrogate endpoint so if the drug concentration is similar it is assumed the generic drug will have act in a similar way to the original
