U12 CLINICAL TRIALS (EXPERIMENTING WITH HUMANS) Flashcards
What is a clinical trial?
Any research study that prospectively assigns HUMAN PARTICIPANTS of groups human to one or more HEALTH-RELATED INTERVENTIONS to evaluate the effects on health outcomes.
What are clinical trials of drugs?
a systematic study of pharmaceutical products on human subjects in order to determine or verify the clinical, pharmacological and adverse effects with the OBJECTIVE of determining their SAFETY and EFFICACY.
What do COHORT STUDIES consist on?
comparing the frequency of a disease between two populations; one that IS exposed to a particular exposure or risk factor, and another that ISN’T exposed
What is the objective of the methodolgy in a clinical trial?
- Detect real differences between compared drugs or therapeutic strategies and
- Eliminate non-real differences
What is the procedure of methodoly?
- Sample size
- Sample selection
- Masking
What does the sample size consist on?
- Variables involved: hypotheses (quatitative or qualitative)
- Magnitude of the effect: clinically relevan
- Variability of the main variable
- Possible errors
What are the 2 possible erros in the a clinical trial?
- Alpha: probability of a false positive (new drug better, but not true)
- Beta: probability of a false negative (we cannot demonstrate that the new drug is better than placebo, but it is better)
What are the 3 types pf sample selection?
- Simple
- By blocks (each half recives treatment)
- Stratified (by categories) ex: separate smokers and non-smokers and RANDOMIZE WITHIN EACH GROUP
What is the main objective of masking?
Concealing the treatment to avoid influencing its evaluation
What is the placebo effect and why is it useful?
- An inert product, with no known therapeutic effects, that the patient is offered in clinical trials to compare it with another therapeutically active product.
- An improvement of a patient’s symptoms when taking a substance without effects related to the treatment of the disease causing the symptoms
What are the 5 types of masking?
- open (unmasked)
- single blind (patient)
- double blind (patient + researcher)
- triple blind (patient + researcher + analyst)
- blind for third parties (patient and researcher know, but not a third analyst)
The classification of the types clinical trials is done according to…?
- Design
- Phase of the study
- Objective
According to the design of clinical trials, it can be…
- Controlled: comparison between two groups
- Not controlled: no comparison or historical comparison. There is no placebo group
The different types of controlled design can be…
- Parallel design
- Crossed design
- Factorial desgn
What does the parallel design consist on?
- one randomisation to separate two grupos; placebo and treatment
- Obtaning results from both groups
What does the factorial design consist on?
- two randomizations. first to separate placebo and treatment group and second to have a placebo and treatment group inside each of the previous groups.
We obtain 1 group that has had both tratments
What does the crossed design consist on?
one radomization but were all of the patients recieve both treatments in a different sequence
Which are the study phases?
1: studing safety and tolerability, healthy volunteers, small samples
2: studies efficacy, dise, form of treatment
3: studies the active principle for the specific disease –> Usually two of these phase are requiered
4: is done after commercialisation. studies new indicators, new ways pf administration, effectivess… Large sample
In EXPLANATORY studies what are the:
- goal of the study
- phase of clinical development
- inclusion criteria
- type of patients
- sample size
- randomisation
- objectives
- main variable
- statistical analysis
- knowledge concerning a treatment
- phase 1, 2 and early 3
- restictive
- homogeneous sample
- small
- conditions differ from clinial pratice
- pharmacokinetics, pharmacodymanics, dose…
- biological relevance
- protocol
In PRAGMATIC studies what are the:
- goal of the study
- phase of clinical development
- inclusion criteria
- type of patients
- sample size
- randomisation
- objectives
- main variable
- statistical analysis
- decide on clinical use
- phase late 3 and 4
- less restrictive
- heterogeneus sample
- big
- conditions similiar to clinical practice
- effectivity, tolerability, safety…
- clinical relevance
- treatment intention
What are the principles involves in ethical evaluation?
- Principle of non-maleficence
- Principle of justice
- Principle of autonomy
What are the limitations of clinical trials in CLINICAL TRIALS entaling:
- nº of patients
- duration
- type of patients
- indications
- associated pathologies
- interactions
- dose
- therapeutic compliance
- small
- short
- adults
- restricted
- no
- limited
- standarized
- controlled
What are the limitations of clinical trials in CLINICAL PRACTICE entaling:
- nº of patients
- duration
- type of patients
- indications
- associated pathologies
- interactions
- dose
- therapeutic compliance
- large
- long
- adults, children, elderly, pregnant
- less restricted
- yes
- broad
- variable
- non-controlled
What were the ethical problems in the 18th-19th C?
experimental research
What were the ethical problems in the 20 C?
experiments with prisoners, children and psychiatric patients
Why was the nuremberg code created?
because of the atrocities committed during the war
What does the nuremberg code state?
- Voluntary consent of participants
- Trial should not have alternatives for avoidance
- Procedure should avoid unnecessary suffering
- The degree of patient risk should be consistent with the humanitarian relevance of the study
- Study performed by skilled personnel
- Patients may interrupt participation at any moment without any reason other than a wish to do so
Under what conditions should clinical trials be carried out stated by the current legistation?
Conditions of respect for the fundamental rights of the person and the ethical postulates that affect biomedical research
A clincal trial can only be iniciated if there is…
(stated by the current legistation)
sufficient scientific, pharmacological and toxicological data on animals are available to ensure that the risks involved with participating people are admisible
Clinical trail can only be iniciated to…
(stated by the current legistation)
demonstrate the efficacy and safety of the proposed therapeutic modifications
The subject of the trial…
(stated by the current legistation)
shall give his written consent freely, after having been informed of the nature, importance, implications, and risks of the clinical trial. This subject can revoke their conest without any cause
If the person can’t issue freely their consent…
such consent must be granted by their legal representative after previous instruction of the scope and risks of the trial
Before incitating a clinical trial there must be a favorable report conducted by
Ethical Committee for Clinical Research
About offshoring clinical trials…
(Bad practice for clinical trials, doing clinical trials in places that don’t have a regulation for them)
- advantages for multinacionals
- advantages for the countries
- the risk of ethical transgression is higher under these conditions
Some of the ethical problems in places that don’t have ethical regulation for clinical trials are:
- Concerning informed consent
- Respect for culture and traditions
- Standard of care or usual local treatment
- Future availability of treatments
What are the ethical requirements in places that don’t have ethical regulation for clinical trials?
- The protocol for each trial must be ethically and scientifically evaluated first by the sponsoring country
- Ethical standards should not be less demanding
- The host country authorities and committees should ensure that research responds to the country’s needs and priorities and meets ethical standards
