PHARMACOEPIDEMIOLOGY & CLINICAL TRIALS 1700-1900 Thu

PRELIM

Pharmacovigilance documents intended to provide a safety update resulting in an evaluation of the

impact of the reports on the risk-benefit balance of a medicinal product.
 Spontaneous reporting
 PASS
 PAES
 PBRER/PSUR
 RMP

Studies intended to show that the investigational drug is not worse than the control.
 equivalence trials
 bio-equivalence studies
 superiority trials
 non-superiority trials
 non-inferiority trials

The use of cross-over study design is applicable to:

 case-control studies
 case series studies
 cohort studies
 randomized controlled clinical trials
 bio-equivalence studies

Which phase of the drug approval process does bio-availability studies commence?
 phase 3 clinical trials
 phase 1 clinical trials
 pre-clinical phase
 phase 2 clinical trials
 post-marketing surveillance

Amlodipine is already an established off-patented drug available only as a 5 or 10mg tablet. If a

parenteral formulation of amlodipine is to be develop, it is then considered a new drug application and
will require a clinical trial to establish its efficacy and safety,
 True
 False

Identify and characterizes ADRs in special populations

 active surveillance
 passive surveillance
 cohort event monitoring
 targeted clinical investigation

Epidemiological methods are used for data analysis

 PAES
 Spontaneous reporting
 PBRER/PSUR
PHARMACOEPIDEMIOLOGY & CLINICAL TRIALS 1700-1900 Thu

 RMP
 PASS

Genetic study
 variables measurement
 therapeutic orphan
 medication error review
 new born screening
 drug-drug interaction analysis

A company, firm or non-profit organisation that has been granted a marketing authorization and,
therefore, allowed to market that specific medicinal product
 marketing authority holder
 inventory
 marketing authorization holder
 patent owner
 innovator

The highest in terms of quality of information

 meta-analysis
 randomized controlled clinical trials
 systematic reviews
 cohort studies
 expert opinions
 cross-sectional

In silico drug discovery

 drugs of natural origin
 synthetic drugs
 drugs discovered using biotechnology
 computer aided via computational chemistry

All of the following are true of new drug applications (NDA), except:
 the preparation is usually the innovator
 exempted from post-marketing surveillance
 has satisfied clinical trials phase 1, 2 & 3
 a premarket submission to the US FDA requesting to obtain approval for marketing a new drug
 patents can be applied

Mitigates the risks in which the ADRs caused by drug products can be explored, minimized or prevented
 PSUR
 risk management
 post-marketing surveillance
 drug safety monitoring
 monitored release
 pharmacovigilance
PHARMACOEPIDEMIOLOGY & CLINICAL TRIALS 1700-1900 Thu

In the case control study "Is vitamin D deficiency associated with higher hospitalization risks from
COVID-19", the intervention used was cholecalciferol tablets
 False
 True

The most convenient dosage form to be used to facilitate blinding of treatments during clinical trials:
 tablet
 syrup
 suspension
 capsule? – feeling ko
 lozenges

If a drug product is a new fixed dose combination or has a new indication, it is considered a new drug
and will, therefore, require clinical trials
 True
 False

These studies are examinations of the use of drugs at one specific point in time
 case-control
 cross-sectional
 crossover
 hybrid
 case series

Gold standard in drug efficacy and safety

 randomized placebo-controlled double-blind clinical trials
 crossover studies
 bio-equivalence studies
 parallel study designs
 cohort designs
 case-control series

In clinical trials, all the following will help reduced bias, except:
 the use of placebo
 the use of inclusion & exclusion criteria
 blinding
 the inclusion of confounding variables
 homogenization
 randomization

The comparison of the efficacy of combined apremilast and calcipotriol compared to calcipotriol
monotherapy in moderately severe psoriasis is a blind study
 True
 False

The discipline of pharmaco-epidemiology encompasses all stages of the drug approval process
 True
PHARMACOEPIDEMIOLOGY & CLINICAL TRIALS 1700-1900 Thu

 False

All of the following are pre-clinical studies, except:

 acute, sub-acute and chronic toxicity studies
 teratogenicity, carcinogenicity and mutagenicity studies
 pharmacokinetic studies
 pre-formulation studies
 small-scale manufacturing of non elegant dosage forms
 solid state analysis of the new drug

COVID-19 vaccines are expedited for their registration at the Philippine FDA due to the urgency of their
use by the public and, therefore, should be exempted from pharmacovigiance monitoring
 True
 False

All of the following are observational studies, except:

 hybrid
 case series
 cross sectional
 randomized clinical trials
 case control
 cohort

QUIZ 1

Pharmacovigilance studies can continue even if the patent of a drug expires

 False
 True

The Forest plot below is typically seen in:

 retrospective cohort trials
 case control studies
 expert opinions
 systematic reviews
 placebo-controlled double blind randomized clinical trials
PHARMACOEPIDEMIOLOGY & CLINICAL TRIALS 1700-1900 Thu

 meta-analysis

The data given below shows that the generic drug is just as bio-available as the innovator preparation
 True
 False

Has the highest quality of information due to filtration of data and information
 Randomized, double-blind, placebo-controlled clinical trial to assess the safety and effectiveness
of a novel dual-action oral topical formulation against upper respiratory infections
 Prospective Study: Definition, Examples…
 Case Reports – the CARE Statement | Evidence-Based Dentistry
 A Case-Control Study Of Preeclampsia And The Future Development Of Cardiovascular Risk
Factors | Journal of the American College of Cardiology
 The effect of raloxifene augmentation in men and women with a schizophrenia spectrum
disorder: a systematic review and meta-analysis

Amlodipine is an oral calcium channel blocker that is long off-patent and is used as an antihypertensive
and anti-arrhythmic. If a new injectable formulation of amlodipine is available, it still has to be
registered with the Philippine FDA as a NEW drug application
 False
 True

COVID-19 vaccines are approved by the Philippine FDA as:

 monitored release
 new drug applications
 accelerated approval
 emergency use authorization
 orphan drugs

The design of bio-equivalence study will prefer a parallel design over a cross-over study
 True
 False

Healthy human volunteers are enrolled during:

 post-marketing surveillance
 phase 2 clinical trials
 phase 3 clinical trials
PHARMACOEPIDEMIOLOGY & CLINICAL TRIALS 1700-1900 Thu

 phase 1 clinical trials

In the Philippines, regulatory pharmacists working as pharmacovigilance officers are well adept in the
preparation of documents during the
 post-marketing surveillance
 phase 2 clinical trials
 drug discovery stage
 pre-clinical studies
 phase 3 clinical trials
 phase 1 clinical trials

In terms of reliability of information, this is an example of the GOLD STANDARD:

 A longitudinal and case-control study of dropout among drug users in methadone maintenance
treatment in Haiphong, Vietnam
 Substance Abuse: A Literature Review of the Implications and Solutions
 A Phase Iii, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of The Efficacy
And Safety Of Neucardin™ In Patients With Chronic Heart Failure | Journal of the American
College of Cardiology
 Case report and case series
 Study protocol title: A prospective cohort study of low back pain

QUIZ 2

if a drug product is claimed to have a NEW clinical indication, it still has to be registered with the
Philippine FDA as a new drug application
 True
 False

The practice of monitoring the effects of medical drugs after they have been licensed for use, especially
in order to identify and evaluate previously unreported adverse reactions.
 pharmaco-epidemiology
 pharmaceutical regulatory affairs
 pharmaco-economics
 pharmacovigilance
 public health pharmacy

Clonidine is a centrally-acting antihypertensive drugs used to lower blood pressure in hypertensive

urgencies. However, some developmental pediatrician use this among children with ADHD who have
difficulty sleeping. Is this an off-label use of the drug?
 Yes
 No

Strategy/ies used to reduce bias:

 Both A & B
 the use of placebo and controls
 randomization
PHARMACOEPIDEMIOLOGY & CLINICAL TRIALS 1700-1900 Thu

 blinding
 A, B & C are correct

In pharmaco-epidemiology, both efficacy and safe-use of a drug product in a given large population
must be studied
 True
 False

Representation of parallel study design | Download Scientific Diagram

 non-inferiority trials
 placebo-controlled
 bio-equivalence studies
 cross-over study design
 parallel design

Making a new, unapproved drug available to treat a seriously ill patient when no other treatments are
available
 emergency use authorization
 compassionate drugs
 orphan drugs
 new drug applications
 investigational new drugs

The off-label uses of a drug should be considered in its inclusion in a formulary

 True
 False

If the test drug and a comparator drug do not look alike physically, blinding during RCTs is not possible.
However, blinding is possible if both test and comparator drugs are super-encapsulated to fit in large
capsules that look the same.
 Both statements are false
 The first statement is true and the second is false
 Both statements are true
 The first statement is false and the second is true

An INVESTIGATIONAL NEW DRUG application is performed:

 during the formulation of non-elegant dosage forms
 prior to the commencement of clinical trials
 during post-marketing surveillance
 during the drug discovery process
 after satisfactory phase 3 clinical trials

MIDTERMS

Question 1
4/4
PHARMACOEPIDEMIOLOGY & CLINICAL TRIALS 1700-1900 Thu

In this Forrest plot, which Canadian province are fluroquinolones neither harmful nor beneficial?

 British Columbia
 Alberta
 Saskatchewan
 Nova Scotia
 Ontario
 Manitoba

Question 2
7/7
Which of the following is true regarding the figure below:

 The informed consent does not apply to those who have withdrawn from the study
 Out of the 17,163 patients with pulmonary TB, 382 MDR-TB volunteers were finally enrolled into
the study
 After inclusion criteria was applied, 286 MDR-TB patients were enrolled into the study
 The 17 patients who did not participate has the right to withdraw from the study at any time
for whatever reasons
 If efficacy of streptomycin + INH/RIF/PZA/EMB + Levofloxacin is to be evaluated for safety and
efficacy in this study, this cohort trial will be RETROSPECTIVE in nature

Question 3
0/4
The most preferred in meta-analysis
 randomized clinical trials
PHARMACOEPIDEMIOLOGY & CLINICAL TRIALS 1700-1900 Thu

 prospective cohort trials

 case-series
 cross-sectional studies
 systematic reviews

Question 4
6/6
Meta-analytical studies have the HIGHEST quality of data because:
 data are filtered
 confounding variables are taken into considerations
 blinding
 it uses positive control - comparator drugs
 publication biases are eliminated

Question 5
5/5
The first step in the conduct of a systematic review:
 formulate the research objective
 appraise the risk of bias and extract data
 synthesize the findings
 screen and select studies
 submit for peer review

Question 6
0/7
Which item is true for the graph below:

 it is a cross-sectional study
 there are no significant differences in the risk of monotherapy failure between rosiglitazone and
glyburide
 meta-analysis and systematic reviews are required to confirm the results of this study
 monotherapy with glibenclamide is least likely to fail in controlling fasting blood sugar
 there are no significant differences in the risk of monotherapy failure between metformin and
rosiglitazone

Question 7
2/2
Cohort studies are trials where data are collected from individuals at a certain point in time
PHARMACOEPIDEMIOLOGY & CLINICAL TRIALS 1700-1900 Thu

 True
 False

Question 8
4/4
In a meta-analysis, the funnel plot below measures:

 sampling error
 publication bias
 population
 confounding variables
 random errors

Question 9
4/4
Z in this case is a confounding variable?

 True
 False

Question 10
0/4
The student report on "Effect of antibiotic prescribing on antibiotic resistance in individual children in
primary care is a/an:
 prospective cohort trial
PHARMACOEPIDEMIOLOGY & CLINICAL TRIALS 1700-1900 Thu

 concurrent cohort trial

 retrospective cohort trial

Question 11
5/5
Anal fistula complicated by urinary tract infection in a 90 year old female Caucasian presenting with
colorectal cancer: evidence of efficacy with methotrexate
 case report
 case-controlled study
 case series
 expert opinion
 proceedings

Question 12
0/6
The figure in Question no. 1 is a/an:
 systematic reviews
 placebo-controlled double-blind randomized clinical trials
 cohort trial
 meta-analysis + systematic reviews
 case series

Question 13
2/2
In what year were fluoroquinolones are most resistant to complicated urinary tract infections in addition
to the highest rate of prescription?
Hide answer choices
 2004
 2002
 2001
 2003
 2005

Question 14
2/2
In longitudinal studies, data are collected repeatedly over long periods of time
 True
 False

Question 15
6/6
Which study would show that statins are effective in preventing cardiovascular diseases:
PHARMACOEPIDEMIOLOGY & CLINICAL TRIALS 1700-1900 Thu

 KAPS
 CARDS
 HOPE3
 JUPITER

Question 16
7/7
A pediatrician wants to see the association between the use of tap water for drinking and diarrhea. His
hypothesis is that "children using tap water for drinking are more likely to suffer from diarrhea" as
compared to those who use mineral water. The best study design to apply for this is:
Hide answer choices
 case control
 case report
 expert opinion
 case series
 prospective cohort

Question 17
4/4

 Prospective cohort
 Case control
 Longitudinal
 Randomized clinical trial
 Cross sectional
PHARMACOEPIDEMIOLOGY & CLINICAL TRIALS 1700-1900 Thu

Question 18
0/2
Systematic reviews have better quality of information than meta-analysis
 True
 False

Question 19
3/3
In the Figure in Question no. 8, the heterogeneity is 44%. A high heterogeneity may indicate that there is
excessive clinical diversity in the studies included, and that it is inappropriate to derive an estimate of
overall effect from that particular set of studies.
 True
 False

Question 20
7/7
Exposure and outcomes are measured at the same time
 case-series studies
 cohort studies
 RCTs
 case-control studies
 cross-sectional studies

Question 21
0/4
A meta-analysis is ALWAYS a systematic review
 True
 False

Question 22
0/5

 case series
 randomized clinical trial
 case report
 expert opinion
 case controlled
PHARMACOEPIDEMIOLOGY & CLINICAL TRIALS 1700-1900 Thu

QUIZ

Question 1
1/1
All systematic reviews fall under the meta-analysis category
 True
 False

Question 2
1/1
A confounding variable can contribute to bias
 True
 False

Question 3
1/1
The probability of treatment assignment conditional on observed baseline characteristics
 odds ratio
 confounder
 propensity scores
 confidence interval
 Forrest plot
 homogeneity

Question 4
0/1
The propensity score is the probability of receiving one of the treatments being compared, given the
measured covariates. Covariates are the variables included in the study that are not the outcome or the
exposure of interests and they could be confounders or not
 The first statement is true and the second is false
 The first statement is false and the second is true
 Both statements are true
 Both statements are false

Question 5
1/1
Propensity scores can NOT control or consider confounding bias and variables. Propensity scores can
compare various treatment groups based on baseline information.
 The first statement is true and the second is false
 The first statement is false and the second is true
 Both statements are true
 Both statements are false

Question 6
0/1
In this propensity scoring, the blue bars are the baseline measurements while the red bars are the
predicted outcomes
PHARMACOEPIDEMIOLOGY & CLINICAL TRIALS 1700-1900 Thu

 True
 False

Question 7
0/1
Which is true of the graph below:

 A lower population of non-initiators is likely to result to high propensity scores

 At lower populations, initiators have higher propensity scores
 At higher populations, initiators are likely to result in lower propensity scores
 At higher populations, non-initiators are more likely to have higher propensity scores
 For non-initiators, the likelihood of getting higher propensity scores is limited up to a certain
threshold

Question 8
1/1
A clinician wants to find out the association between longer use of statin drugs and cardiovascular
death. What is a possible confounder for this?
 caffeine-rich diet
 alcoholism
 obesity
 age
 2 of the above
 3 of the above
 all of the above
PHARMACOEPIDEMIOLOGY & CLINICAL TRIALS 1700-1900 Thu

Question 9
1/1
Propensity scores are widely used to deal with confounding bias in medical research. An incorrectly
specified propensity score model may lead to residual confounding bias,
 The first statement is true and the second is false
 The first statement is false and the second is true
 Both statements are true
 Both statements are false

Question 10
1/1
You collect data on sunburns and ice cream consumption. You find that higher ice cream consumption is
associated with a higher probability of sunburn. What is a good example of confounding variable for
these 2 entities?
 age
 bacterial skin diseases
 extreme fluctuations in temperature
 sex
 hypertension