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| 4839205828 | What is Evidence Based Medicine? | It is integration of the best clinical evidence, pathophysiology knowledge, and pt preference to make a clinical decision. It leads to better outcomes and is widely viewed as the standard of care. | 0 | |
| 4839205829 | What is a Case Report? | In its simplest form: We learn from experience. So we write about how we do it and other people write about how they do it. And we learn from that. | 1 | |
| 4839205830 | What is a Case Series? | In simplest form: we get # of cases of pts with disease, summarize it 10-15 cases and publish it. ***helpful with rare disease, and you get literature on how to care/tx them | 2 | |
| 4839205831 | What is a Case Control? | In simplest form: We take cases and matches them with controls who don't have the disease | 3 | |
| 4839205832 | What is a Clinical Trial? | A study design allowing comparison of treatment outcomes vs. 2 or ore evaluated groups @ same time with same protocol. Layman: look at 2 or more groups to see which is best | 4 | |
| 4839205833 | What all goes into Pre-testing? | we start with test tube, work our way into 2 species animal studies, and then look at the kinetic and dynamic pharmacologic profiles of the drug and from that find what will work in human. | 5 | |
| 4839205834 | How many phases must we go through before we can have final product? | 4 phases | 6 | |
| 4839205835 | What happens in Phase 1? | Typically college aged 18yo and you give them drug to see what the max dose you can safely give someone. These studies evaluate how drug should be given and how often. Typically look at less than 12 pts. | 7 | |
| 4839205836 | What happens in Phase 2? | When you are looking at safety of drug and secondary efficacy. Usually look at healthy and sick folks. Wanna get around <200 pts and check for changes in pt status asking daily questions, drawing blood often, and asking pts how they feel. | 8 | |
| 4839205837 | What happens in Phase 3? | Testing now has a specific target. You are comparing the new drug to the standard of care. Usually will require between 250-10,000 pts w/ specific disease you are trying to treat. This is when drug is looking for FDA approval. ***Placebo vs. Drug*** | 9 | |
| 4839205838 | What happens in Phase 4? | this is known as post market surveillance on already approved drugs. Basically we monitor the drug in specific populations and look for new indications to use that drug. | 10 | |
| 4839205839 | Hx of clinical trial? First diet? | First diet clinical trial dates back to book of Daniel when the slaves were given kings rich food and wine vs. water and veggies. | 11 | |
| 4839205840 | What did Lind study in British Sailors? | Studied the effects of Vitamin C deficiency.... gave them all different kinds of fruits and veggies to see which one offered most improvement. | 12 | |
| 4839205841 | True or False? In a clinical trial you want to accept the null hypothesis? | False, our goal is to reject the null hypothesis. So if you say Tx A is better the Tx B.... and HO= Da = Db then you want to reject this because it would mean that Da is not = to Db | 13 | |
| 4839205842 | What is a type 1 error? | False + look at man and tell him that he is pregnant, when obviously he is not | 14 | |
| 4839205843 | What is a type 2 error? | False - look at woman (who is obviously pregnant) and tell her she is not pregnant, when she actually is | 15 | |
| 4839205844 | What are endpoints and why is primary and secondary endpoints important? | End points are events or outcomes that happen in a clinical trial that can show you if it was effective or not... ex: mortality tx response safety quality of life adverse events come in primary and secondary... but you want to for you question off of the primary endpoint (main thing you are looking at) | 16 | |
| 4839205845 | What is POWER known as? | ability to detect true difference between groups and relates to sample size.... smaller size = weaker power | 17 | |
| 4839205846 | Things that affect and control sample size? | difference in Tx type 1 error rate (drug worked, but it really didn't) power also important to see how many don't complete trial and ask why... did they drop out, did they die, ect. | 18 | |
| 4839205847 | Why do we randomize in clinical trials? | because it provides disassociation from confounders and we want to stay true to the PRINCIPLE that everything between two groups is same except treatment. | 19 | |
| 4839205848 | Types of Bias we face? | Investigator bias= when you know information about the drug or the participants and it sways you to investigate on or the other more closely study design bias= you stick to everything in guideline or standard and discover a difference that shouldnt be evaluated | 20 | |
| 4839205849 | What is the definition of the following? Any intentionally non effective medical treatment especially inactive or inert substances prescribed to replace meds that is desired by patient but are not given. | Placebo which is given to control group | 21 | |
| 4839205850 | What are the three forms of a placebo? | tablets= pharmacological placebo switching off of a device= physical placebo unspecific neutral discussion= physcological placebo | 22 | |
| 4839205851 | What is Blinding/ Masking? | it is a feature used to eliminate bias and if followed up schedule for tx and placebo will render sufficient results | 23 | |
| 4839205852 | Single Masked Study? | only pt doesn't know treatment | 24 | |
| 4839205853 | Double Masked Study? | both patient and doctor don't know treatment | 25 | |
| 4839205854 | What are the bad things associated with a Clinical Trial? | non compliance which you need to factor into sample size (get more numbers then needed) and calculate accordingly loss to follow up: FDA says these ppl marked as failure ethical issues | 26 | |
| 4839205855 | What is the 1947 Nuremberg Code of Ethics ? | - declaration of consent by trail participants - pt have right to know info of nature, purpose, and risk of study - pt have right to withdrawl at any time - trail must aim for beneficial results and that the risk involved must not outweigh the benefits gained from society for participation in study | 27 | |
| 4839205856 | How do we assess a clinical trial statistically? | RR Chi-Square= % comparison T-test= mean comparison | 28 |
