Lecture bioinformatic databases - Tuesday - Theory of clinical trials
18 important questions on Lecture bioinformatic databases - Tuesday - Theory of clinical trials
How to deal with confounding by indication (when randomization is not possible)?
--> usually, adjustment in statistics cannot remove all confounding
What are the phases of a clinical trial?
- phase I = safety study (20-80 people)
- phase II = side effects and effectiveness (100-300)
- phase III = effectiveness and monitor side effects (1000-3000)
- phase IV = monitor long-term side effects
What is tested in the phase I of a clinical trial?
- Higher grades + faster learning
- Never study anything twice
- 100% sure, 100% understanding
For my 1st exam I got a C. Then, I started looking for ways to learn better and I came across Study Smart. Since then I have scored a A+, A, A- and another A. I highly recommend it to everyone who wants to hear it. I am so happy with it!!
I was struggling to finish all my first-year subjects for 3 years. Then I discovered Study Smart, which helped me to finish all of them within 3 months.
Because of StudySmart, things are going well in many ways. Before, I always had study stress and no time for anything. Now I feel calm and confident (because of the program). I used to score a B, now I usually score an A or A+.
Hey Chris, I really want to thank you very much for developing the platform, I usually got around C for my exams, now I scored an A+, an A and a A- !!
Since using Study Smart, my average has increased significantly. I even completed a statistics course with a A+ while I'm bad at statistics. I took on extra courses this year, because of Study Smart. Thanks so much!
Ever since I started studying with StudySmart I passed all my exams !!! No more re-sits!! At first, I was happy with a pass and now I only get good grades. Many thanks!
I aced all the courses I studied with Study Smart. For law, I first scored a D, and now an A! I’m 100% sure that I’ll pass all the courses I study with Study Smart.
I always thought I studied well. My grades were fine. I could never have imagined that applying these study skills would have such a huge and direct impact on my grades, my speed and the pleasure I have in learning.
For the first time, I finally feel totally confident about the way I learn. I have the perfect overview and make great progress in terms of speed and the grades I get. Thanks, Chris!
I immediately started to enjoy learning again, and my grades soared. All of a sudden, everything went better. I highly recommend Study Smart to all students..
Being able to create my materials online made the process of studying so much smoother and quicker. I no longer have to spend a huge amount of my time on creating my summaries.
At first, my notes were a mess. Now I use Study Smart to take my notes in a perfectly structured way. It helps me to save a lot of time and do other things I enjoy.
Students that study with Study Smart get better grades. The system applies all the learning methods in such a way that both well-performing students and students who struggle perform much better.
Hi Chris, I would like to thank you very much. Last year I scored C on a course, and this year I got an A+ thanks to your method! Thank you very much!
The largest effect is that my child is more enthusiastic about school! Every parent wants their children to be happy at school, Study Smart made it happen.
In high school, I failed several exams, and that has really changed now. I actually needed this tool very much back then. Since I started studying with StudySmart, I haven't had any D's. My average score is now an A and those are results I would have never had in the past
With my old method, I passed only 3 out of 8 courses. Since I started taking my notes digitally in Study Smart, I have passed all my courses on the first try. For me, StudySmart takes away the stress of wondering if I will pass or not.
Thanks to StudySmart, I passed all my exams, and with better grades than before! On top of that, I have mastered a very good study method now, which I am confident will help me earn my degree.
What is tested in a phase III trial of a clinical trial?
What is tested in a phase IV trial?
What is a placebo?
Difference medication, prosthesis and surgical experiment
Prosthesis = new material versus old
Surgical = new technique vs classical
What is the index group and what the control group?
Control = placebo or standard treatment
Why is a control group necessary?
What is a cross-over experiment?
There is a wash out period in between the two treatments.
What is the problem with simple randomisation?
In case of interim analysis, unequal distribution of subjects
Treatment groups not balanced with respect to risk factors of prognostic factors
What is block randomisation and what is the advantage?
Advantage: Equal number of subjects in the treatment groups (even if study is terminated early). Is used in multicenter trials.
Randomization of blocks of subjects of even size (4, 6 8 etc.)
Half of the patients of each block are assigned to treatment A and other half to B
Termination of trial: always approximately equal number of subjects
What is stratiefed randomisation and what is the purpose?
Before study entrance subjects are subdivided in groups, strata, based on baseline characteristics.
Subjects in each stratum are randomly assigned to a treatment group.
Use stratified randomisation in combination with block randomisation.
Knowledge of treatment will influence the evaluation of the outcome, how can this be solved?
- single blind = participants are given no information about the identity of their treatment
- double blind = neither participants nor investigators are aware of the identity of the assigned treatment
What are open label studies?
What is internal validity and external validity?
External = generalizability of results, clinically important outcomes, benefit vs harm
What are two types of clinical trials?
- how does treatment work and what is the efficacy (werkzaamheid) of treatment
Pragmatic = effectiveness trial
- How should I treat patients with this disorder?
- Effectiveness (doeltreffendheid) of treatment
How can one present effect sizes?
Relative risk (hazard ratio)
Absolute risk difference
Relative risk reduction
Number needed to treat / number needed to harm
Try our study magic for free
a PDF, study it super fast
- No sign up, email or credit card needed!
- AI makes unlimited flashcards
- Get unlimited quizzes and tests
- Ask AI anything
- No sign up, email or credit card needed!
- Have and keep perfect overview
- Make flashcards, notes and mind maps
- Review, test and score!
The question on the page originate from the summary of the following study material:
- A unique study and practice tool
- Never study anything twice again
- Get the grades you hope for
- 100% sure, 100% understanding
