Lecture 3
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what is clinical research?
-medical research that involves people like us it involves human participants and helps translate basic research into new treatments to gain insight on how disease and health progress
volunteer participation in investigations with the objective of……
discovering better ways to treat, diagnose and understand human disease
clinical trials are sponsored by what?
-by various organizations like physicians, foundations, medical institution and pharmaceutical companies
what is randomization?
process by which treatments are assigned to participants by chance to avoid any bias aka double blind
what do clinical trials compare
they compare new therapy with existing therapy to determine if the new is as better or better than the existing treatment
true or false in all studies there is a placebo
false it is in some
why is there unique eligibility criterias in each study?
to identify appropriate participants and keep then safe and to ensure researchers xan find the new information that they need
all trials have guidelines about who can participate called the…..
inclusion/exclusion criteria
what are criteria based on…
age, gender. stage of disease. current medications, previous treatment and other medical conditions
what are the main infos on the 4 phases?
-is it safe -does it do what it is supposed to do -how does it compare -what happens in the long term
Phase 1: is it safe? purpose and number of peeps
-find out whether a medical approach is safe and can be tolerated: we assess side affects
phase 2: does it do what it is supposed to do: purpose and number of peeps
-start testing whether a medical approach works. Continue monitoring for side effects, determine opportune dose and collect data -between 100-300 peeps
phase 3: how does it compare? purpose and peeps
-confirm whether a medical approach works: continue monitoring side effects -usually 1000 or more
phase 4 what happens in the long term: purpose and number of peeps
-when a medical approach goes to a market, continue gathering info for long term effects -number of peeps: thousands
why participate to a study
-gain access to new research treatments before widely available -receive regular and careful medical attention from a research team -help other by contrinuting to medical research -play an active role in your own health care
what are adaptive trial designs
-basically you can put phase 1-2 together and 3-4 -allos trial flexibility by using accumulated results
true or false: adaptive trial designs are more efficient, informative and ethical
true they use less participants and better use of time and money
what is a part of the clinical research uni
-neurologists -raters: questionnaires -nurses: blood draws and vitals -imaging center aka mri
what is nusinersen used for
treatment of spinal muscular atrophy
what is tofersen used for
as for a rare form of ALS: usually hits older people
what is the gene for ALS
sod1 and it is genetic
why was valor not a slay for tofersen
-thet thought it would be a huge slay -They got fucked and failed to meet primary disease -Indicators of the disease were getting better tho -People that were normal progressors are regaining normal function -Mistake was on the clinical designs -They got recovery from the disease
how does insurance works after the drug is approved by health canada
After drug approved by canada our province has to decide if it is gonna be available for us and through insurances and if its in hospitals