Module 1 Key: Flashcards
The only type of research that can establish a causal link between the exposure and the effect.
When properly executed, a clinical trial can establish a causal link between the exposure and the effect.
This is the only way, through a clinical trial. The best! Because you are testing on humans, real world.
it would be possible to conclude that the experimental treatment controls blood pressure better than standard treatment in patients with hypertension
RCT studies are generally prospective. What does that mean?
participants are recruited, treated, and followed for a certain time in order to evaluate the evolution of their state of health.
True or False:
(Biomedical) science before statistics, not the other way around.
True
When would it be unethical to use a placebo?
when there are other effective interventions, it is often unethical to use a placebo as a comparator: Concept of comparing to Standard of Care
Describe PICODE
- P: Population
- I: Intervention
- C: Control
- O: Main clinical outcome (O for “outcome” in English).Primary outcome endpoint (PRC)of the study.
- D: Area of Application (Therapeutic, Prevention, Depistage)
- E: design d’étude (randomisée, cohorte, observationnelle, double blind)
Thérapeutique, prevention vs depistage types of participants
Thérapeutique: patients atteints d’une maladie
Prévention and depistage: participants en santé
Describe what this means:
À noter que non-inférieur ne veut pas dire équivalent.
Un traitement équivalent n’est ni inférieur et ni supérieur par rapport à l’autre. Par contre, un traitement non-inférieur pourrait être supérieur au traitement standard.
What does this describe;
Prévenir ou reporter la progression de la maladie
Dépistage
What does this describe:
Prévenir ou reporter les conséquences de la maladie.
Thérapeutique
Prévenir ou reporter les conséquences de la maladie ou la guérir
Generally speaking, for what group are the risks more tolerated?
For very sick patients
Generally speaking, the risks are more or less acceptable depending on the therapeutic area.For example, significant adverse effects (e.g. hair loss) will be tolerated for terminally ill cancer patients if the intervention could double or triple survival.But this would not be tolerated for much less severe medical conditions (e.g. hypertension).
For therapeutic you are more likely to allow a higher risk but for screening and prevention (healthy people) the risk is less tolerated.
Would this require approval of Health Canada:
aspirin (approved as an analgesic) used for the prevention of cardiovascular diseases
Yes.A claim for another disease leading to a change of indication will require new approval.
Would this require approval of Health Canada:
prevention of certain cancers with vitamin D supplements
Nope
Can a vacinne or medication ever be used wihout approval?
Yes
In force majeure situations, such as a public health emergency (COVID-19), it is possible to allow the use of a vaccine or medicine before obtaining approval.
Clinical trial phases. Phase 1 type of participants, number of participants and goal. What determines is you can go to Phase 2?
- These participants are healthy
- Given that these are the first evaluations in humans, we proceed very cautiously by exposing very few participants
- The goal of a Phase I study is to detect common side effects. Phase I can be used to determine the maximum tolerated dose and the safe dose.
- If the safety profile is acceptable, we will then proceed toPhase IIstudies
Clinical trial phases. Phase 2 type of participants, number of participants and goal. What determines is you can go to Phase 3?
- Patients or people that can benefit from intervention
- More people but not a huge amount
- The objective of phase 2 is still safety (but in the** patients targeted by the treatment**) but we will also be interested in effectiveness.
- If the safety profile remains acceptable, Phase IIIstudies will be carried out.
