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M.PHARM ( PHARMACOLOGY )
2ND SEMESTER
CLINICAL RESEARCH AND
PHARMACOVIGILANCE
PHARMACOEPIDEMIOLOGY
Pharmacoepidemiology is the study of interactions between drugs and
human populations, investigating, in real conditions of life, benefits, risks
and use of drugs. Pharmacoepidemiology applies to drugs the methods
and/or reasoning of both pharmacology and epidemiology.
PHARMACOEPIDEMIOLOGY
• Advantages of pharmacoepidemiologic research are the availability
of data from larger groups of patients, and coverage of under-
researched subpopulations, allowing more diverse populations to be
looked at compared to clinical trials.
• Drawbacks of observational pharmacoepidemiologic studies come
from the non-randomised nature of group selection, leading to
various kinds of possible interference by confounding factors
(variables).
• Potential methods for managing this drawback include for instance
active comparison groups, within individual designs.
• Many of the more rigorous pharmacoepidemiology studies have been
strengthened through multiple analytical approaches to improve
confidence in inferred causal relationships.
Epidemiologic studies often are divided into two types, descriptive and analytic,
and each of these uses specific kinds of studies.
 Descriptive studies examine patterns of disease occurrence, with a focus on
person, place, and time. These studies use relatively accessible data to estimate
caseloads, to determine the amount of public health resources needed, or to
identify high risk groups. Descriptive studies are useful if very little is known
about a new disease or condition. They can be used to generate hypotheses on
risk factors and causes of disease that need to be confirmed or ruled out by
analytic studies. The most basic types are: a case report, a case series, and an
incidence study. These types of study involve no comparison group. They are
merely descriptive.
 Analytic studies aim to identify and evaluate determinants, causes or risk
factors of diseases or health-related events. In contrast to descriptive studies,
which generate hypotheses, analytic studies are used to test hypotheses. They
are often employed to analyse the distribution of exposures and diseases and to
look for and measure associations. These types of studies typically require
more resources and expertise and can be rather complex. A key feature of
analytic studies is that they involve comparison groups.
TYPES OF EPIDEMIOLOGY
 Experimental studies have the distinguishing characteristic that the intervention being
tested (e.g., preventative or therapeutic measure) is allocated by the investigator to a
group (sample) of study participants drawn from a population (individuals, households,
communities). Participants are followed prospectively to compare the intervention vs.
the control (standard treatment, no treatment or placebo) and detect the effects of the
intervention (exposure). The main interventional study design is the randomised
controlled trial (RCT) (randomised, meaning the participants are grouped by chance).
 Observational studies take place in a real-world setting, and it is not possible for the
researcher to control all possible variables. Observational studies therefore lack the
‘manipulation’ of an independent variable, control of extraneous variables through
random assignment of study participants, or both. Researchers observe the effect of risk
factors, or health interventions, without trying to change who is or isn’t exposed.
Observational studies come in four main types: Cohort, case-control, cross-sectional,
and ecologic. Observational studies tend to be more flexible and allow for a greater
range of topics to be studied.
TYPES OF ANALYTIC
THIS FIGURE SHOWS :
Pharmacoepidemiology through medicines development and post
approval
THIS FIGURE SHOWS :
Illustration of the relationship between pharmacoepidemiology and several contributing
disciplines. PK: pharmacokinetics; PD: pharmacodynamics.
APPLICATION
• Prediction of the magnitude (frequency and size) of the likely effects of the
medicine, both intended and unintended.
• Development of measurement scales to capture patient-reported outcomes
(PRO) that are linked to efficacy and safety measures.
• Design of clinical efficacy trials.
• Development of an expected safety profile.
• Development of risk management plans and post-marketing safety studies.
• Reassurance about medicines safety
• Supplementing the information available from premarketing studies – better
quantitation of the incidence of known adverse and beneficial effects, e.g.,
 in patients not studied prior to marketing (e.g., the elderly, pregnant women);
 as modified by other medicines and other illnesses;
 relative to other medicines used for the same indication
REFERENCES
1. https://learning.eupati.eu/mod/book/tool/print/index.php?id=664
2. https://learning.eupati.eu/mod/book/tool/print/index.php?id=642
3. https://doi.org/10.1016/j.therap.2018.08.001
4. https://en.wikipedia.org/wiki/Pharmacoepidemiology
Pharmacoepidemiology Studies

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Pharmacoepidemiology Studies

  • 1. M.PHARM ( PHARMACOLOGY ) 2ND SEMESTER CLINICAL RESEARCH AND PHARMACOVIGILANCE PHARMACOEPIDEMIOLOGY
  • 2. Pharmacoepidemiology is the study of interactions between drugs and human populations, investigating, in real conditions of life, benefits, risks and use of drugs. Pharmacoepidemiology applies to drugs the methods and/or reasoning of both pharmacology and epidemiology. PHARMACOEPIDEMIOLOGY • Advantages of pharmacoepidemiologic research are the availability of data from larger groups of patients, and coverage of under- researched subpopulations, allowing more diverse populations to be looked at compared to clinical trials. • Drawbacks of observational pharmacoepidemiologic studies come from the non-randomised nature of group selection, leading to various kinds of possible interference by confounding factors (variables). • Potential methods for managing this drawback include for instance active comparison groups, within individual designs. • Many of the more rigorous pharmacoepidemiology studies have been strengthened through multiple analytical approaches to improve confidence in inferred causal relationships.
  • 3. Epidemiologic studies often are divided into two types, descriptive and analytic, and each of these uses specific kinds of studies.  Descriptive studies examine patterns of disease occurrence, with a focus on person, place, and time. These studies use relatively accessible data to estimate caseloads, to determine the amount of public health resources needed, or to identify high risk groups. Descriptive studies are useful if very little is known about a new disease or condition. They can be used to generate hypotheses on risk factors and causes of disease that need to be confirmed or ruled out by analytic studies. The most basic types are: a case report, a case series, and an incidence study. These types of study involve no comparison group. They are merely descriptive.  Analytic studies aim to identify and evaluate determinants, causes or risk factors of diseases or health-related events. In contrast to descriptive studies, which generate hypotheses, analytic studies are used to test hypotheses. They are often employed to analyse the distribution of exposures and diseases and to look for and measure associations. These types of studies typically require more resources and expertise and can be rather complex. A key feature of analytic studies is that they involve comparison groups. TYPES OF EPIDEMIOLOGY
  • 4.  Experimental studies have the distinguishing characteristic that the intervention being tested (e.g., preventative or therapeutic measure) is allocated by the investigator to a group (sample) of study participants drawn from a population (individuals, households, communities). Participants are followed prospectively to compare the intervention vs. the control (standard treatment, no treatment or placebo) and detect the effects of the intervention (exposure). The main interventional study design is the randomised controlled trial (RCT) (randomised, meaning the participants are grouped by chance).  Observational studies take place in a real-world setting, and it is not possible for the researcher to control all possible variables. Observational studies therefore lack the ‘manipulation’ of an independent variable, control of extraneous variables through random assignment of study participants, or both. Researchers observe the effect of risk factors, or health interventions, without trying to change who is or isn’t exposed. Observational studies come in four main types: Cohort, case-control, cross-sectional, and ecologic. Observational studies tend to be more flexible and allow for a greater range of topics to be studied. TYPES OF ANALYTIC
  • 5.
  • 6. THIS FIGURE SHOWS : Pharmacoepidemiology through medicines development and post approval
  • 7. THIS FIGURE SHOWS : Illustration of the relationship between pharmacoepidemiology and several contributing disciplines. PK: pharmacokinetics; PD: pharmacodynamics.
  • 8. APPLICATION • Prediction of the magnitude (frequency and size) of the likely effects of the medicine, both intended and unintended. • Development of measurement scales to capture patient-reported outcomes (PRO) that are linked to efficacy and safety measures. • Design of clinical efficacy trials. • Development of an expected safety profile. • Development of risk management plans and post-marketing safety studies. • Reassurance about medicines safety • Supplementing the information available from premarketing studies – better quantitation of the incidence of known adverse and beneficial effects, e.g.,  in patients not studied prior to marketing (e.g., the elderly, pregnant women);  as modified by other medicines and other illnesses;  relative to other medicines used for the same indication
  • 9. REFERENCES 1. https://learning.eupati.eu/mod/book/tool/print/index.php?id=664 2. https://learning.eupati.eu/mod/book/tool/print/index.php?id=642 3. https://doi.org/10.1016/j.therap.2018.08.001 4. https://en.wikipedia.org/wiki/Pharmacoepidemiology