Consists of journals and other periodicals wherein medical
and clinical studies are published
Determine which studies are reliable and acceptable by certain
standards
✓ Use the wrong study design
✓ Use the right methods incorrectly
✓ Misinterpret their results
✓ Report their results selectively
✓ Reference other studies selectively or incorrectly
✓ Draw unjustified conclusions from their research
1. Safety and efficacy trials
2. Trials designed to evaluate:
1. Continuing education
2. Critically appraise or evaluate chemical studies
3. Develop skills in literature evaluation
4. Allows RPh to recognize which studies are important, reliable and
deserve attention
5. Used in other fields of pharmacy practice
A. Solving therapeutic dilemmas
B. Patient counselling and information interpretation
C. Other HCP contact RPh for opinions
D. Decisions on drug policy management
6. Not all biomedical literature pass the standards
Consolidated Standards of Reporting Trials
Provide standards, checklists, content suggestions for authors to
use when submitting manuscripts and medical journals
British Medical Journal
JAMA (Journal of American Medical Association)
Lancet
Annals of Internal Medicine
STARDS (Standards for Reporting of Diagnostic Accuracy)
I. Clinical Studies
A. N-of-1 Study
B. Stability or In-Vitro Study
C. Bioequivalence Study
D. Programmatic Research
II. Survey Research
III. Post-marketing Surveillance Study
IV. Overviews
V. Health Outcome Research
VI. Medical Studies
• Determine cause and effect relationship
• Researchers administer a drug or treatment and follow the subjects
forward in time to determine the effects of such treatment
❖ Prospective Study: watches for outcomes, such
as the development of a disease, during the study
period and relates this to other factors such as
suspected risk or protection factor/s.
Compare effects of the drug to the control during multiple
Researchers investigated whether paracetamol was as effective as
non-steroidal anti-inflammatory drugs
observation periods in a (NSAIDs) in the treatment of
single patient
pain and disability related to osteoarthritis of the hip or knee. A series
of double blind,Very effective“n
randomised in confirming causality
of 1” controlled trials was performed.
Each drug was taken for two weeks, administered for a maximum of
five cycles. Thirteen patients in primary care who had regularly been
using NSAIDS were selected. Patients received the same type of
NSAID and in the same dosage, if possible, as they were taking before
the start of the study. Outcome measures included severity of
complaints of pain, stiffness, and limitations in daily functioning,
together with satisfaction with drugs and side effects
Evaluate and determine the stability of drugs in various
preparations under various conditions
Assess the bioequivalency of two or more products
When are drugs considered bioequivalent?
If their rate and extent of systemic
absorption (in the body) “do not show a
significant difference” when administered
at the same dose by the same route and
under the same experimental conditions
Determine the impact of economic value of programs and
services provided by pharmacists in community and
institutional settings
Include an assessment of related research capacity and describe
how the proposed program will build on a strengthen that
capacity
Study the incidence, distribution and relationships of
sociological and psychological variables through the use of
questionnaires applied to various populations
Gathers information from a sample to generalize
findings to a larger, “target” population
❖ Pharmacy
❑ Determine how programs should be
implemented
❑ Understand the behavior of patient or members
of the profession
Evaluate use and adverse effects associated with newly approved
drug therapies
Review articles, analyze, assess and evaluate
previously conducted research studies
Narrative Reviews Qualitative Quantitative
“General Overview” Meta analyses
Nonsystematic Systematic Systematic
Subjective summary Qualitative and Results of conducted
of data from multiple objective summary of clinical trials are
studies data from multiple combined, statistically
studies where the evaluated and
results are not summarized
statistically combined
Medical Studies
Explanatory Descriptive
Observational Experimental Case Report Case Series
Case Control
Randomized
Cohort
CT/Experimental
Cross-Sectional
• Used to document and communicate experiences
• Investigator simply records data from observations made and
draws conclusions as to possible reasons for the events witnessed
• Describe unusual or new events
❖ Major Limitation: Do not provide definitive
explanations, determine causes or supply
evidence that one drug is superior to another
• Based on the observations of individual patients
• Describe and adverse event following the use of a particular drug
or group of drugs or to report a possible DI
• Frequently generate hypotheses to serve as the basis for more
rigorous studies
• Document observations from a group or series of patients
• Used to examine the prior histories of patients with the same
outcome in hopes of identify a possible cause and effect
relationship
• Useful for estimating the incidence of an adverse event of a
newly marketed drug when there is a limited information available
about the particular event
• Used to help ensure that a certain adverse event is
not associated with the use of a drug
More rigorous design to identify answers to questions that arise in
clinical medicine
Employed to determine the efficacy of medications or identify
whether there is a true relationship between the use of a drug
and the occurrence of an outcome
Investigators: Bystanders
Examine the natural course of health events, gather data about the
subjects included and classify & sort the data
Conducted when it is unethical or impossible to
perform clinical studies
“Trohoc Study”
Determines association between disease states and exposure to
various risk factors
Participants with a particular characteristic are
compared to a similar group of participants
without the characteristic to determine the risk
factors associated with the development of that
characteristic
“Follow-up Study”
Determine the association between various factors and disease
state development
A group of subject already exposed to a
certain factor are compared to an unexposed
group of subject and followed prospectively
Development of a disease state of interest is
observed during the study period
“Prevalence Study”
Identifies prevalence of characteristics of diseases in
populations, can be thought of as a “snapshot” because data is
collected and evaluated at a single point in time even if the
observations may cover a period of several months/years
Most ideally suited for generating, rather than
testing hypothesis
Surveys that evaluate opinions/situations
at a fixed point in time and studies focused
on description, diagnosis and mechanisms
of disease states
Prospective trials in which an attempt to regulate the variables
in a study occurs on the part of the investigators
Allows the investigator to help account for the
possible influence that other outside factors
could have on a study’s outcomes independent
of the drug being evaluated
