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Clinical Research Study Designs: A Review

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 REVIEW ARTICLE

Clinical Research Study Designs: A Review

Pradeep Battula1*, T Muneeswar Reddy2, Kali Chandra Shekar2, Divya G1, Dhanunjaya S1,
Durga Prasad T S1, Sridhar C1, Ranganayakulu D1
Abstract: Research study design is defined as a plan, protocol, strategy or scheme of a study. The studies are useful to find out
the unidentified effects and things concerning the drugs and diseases. To solve the troubles regarding the drugs and diseases a
suitable research study design should be selected. The choice of study is based on the purpose of the study. And well designed
study will obviously recognize an exposure and an outcome. The research study designs are classified into two types, one as
observational study, second as interventional and both studies further classified into different types. Observational studies will
be completed in soon or quickly when compared with the interventional studies, but observational studies are useful only for to
set the hypothesis whereas interventional studies useful to test hypothesis and to identify the causes. Apart from these two
studies other studies like Nested hybrid study designs, different Randomized study designs are there to find out the answers for
the particular questions regarding the drugs and diseases. Each study has their own advantages and disadvantages in terms of
the money and time. However, understanding of the various studies is important.

INTRODUCTION errors. [8] The main aim of this review of literature is

Research study designs and pharmacoepidemiological simplifying the concepts and providing brief an idea on
studies are the studies to identification of reasons for research study designs.
diseases, drug effects and uses. Research study design is
defined as a plan, protocol, strategy of a study and Types of Study Designs
Pharmacoepidemiology means “the application of Research study designs are classified into two types as
epidemiological reasoning (Analysis), methods and follows:
knowledge to the study of the uses and effects (Beneficial
and Adverse) of drugs in human population”. [1, 2] These 1. Observational Study Designs
studies are connection among pharmacology, pharmacy, In observational study the subjects or recruited population
bio-statistics and demographic social sciences. [3] To are just observed, as name indicates no interventions are
improve the patient care new drugs are evolving and taken place. [5] Based on the time, observational study
entered into the market with unknown effects as well as designs are further categorized into analytical study and
old drugs too. And diseases with unknown causes present descriptive study (Figure 2). And main goal of the various
in the globe. To find out such unknown effects of drugs and study designs include Descriptive study is to generate
unknown causes of diseases research study designs, hypothesis, Analytical study is to test hypothesis and
pharmacoepidemiological studies are useful. The sequence Experimental study is to prove hypothesis. [4, 9]
of level of evidence and studies include Meta analysis, RCT
(randomized control trail), Non RCT, cohort study, case - a. Analytical Study
control study, cross sectional study, case report. Meta I. Cohort Study
analysis and RCT gives accurate information when Cohort means group of warriors, group of soldiers
compared with other studies as given in sequence in the marching together as per Latin word “cohor” and roman
above. [2] With the help of research study designs literature. [4, 5] Cohort study is also named as: Follow up
investigators must generate some data regarding drugs study (prospective study), [4, 5, 9, 10] Forward looking study,
effects, diseases etiology and perform the interventions [9] Incidence study, [4, 5, 10] Longitudinal study. [4, 5,11]
pertaining to study. So the investigator should elect A cohort study is a study, starts with exposure (risk
suitable study design to find an answer to the question. As factor) and follow for the outcome (disease). That means
we know that investigators and researcher are health the study consists two group’s first group is exposed to
detectors, their ultimate goal is providing better patient some risk factor and second group free from exposure
care. [4, 5] So, especially the researcher should focus on (Figure 3). Then follow the each group to find out the
pediatrics and geriatrics why because they often excluded disease status. Compare the disease risk between exposed
from the clinical trials, thus strange effects will be arising to group and unexposed group.
the special population. [6, 7] To attain better results the For example, a group of smokers and a group of non
researcher must separate out the study into five steps – smokers, follow the two groups for the outcome (lung
planning, performance, documentation, analysis and cancer). Cohort study can assess the cause, natural
publication. At the final stage difficulties may arise to history of the disease, relative risks (RR) and incidence
minimize the errors. The well designed study can minimize rate. The study Disadvantages include greatest cost,
longer time, susceptible to selection bias, loss of follow
1Sri Padmavathi School of Pharmacy, Tiruchanoor, Tirupati-517503, up (attrition). [9] Cohort study can measure risk (it is the
Andhra Pradesh, India. probability of developing an outcome when exposed to a
E-mail: [email protected]
drug) it is calculated by the relative risk (RR), incidence
*Corresponding author
(absolute risk) and risk difference (attributable risk). [2,
2 SV Medical College, Tirupati-517501, Andhra Pradesh, India. 12, 13]

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Research Studies

Observational Studies Experimental Studies

(The Study Does not (The Study Involves
Involve Any Intervention)
Intervention)

Descriptive Randomized Non-randomized

Analytical Study Study

Figure 1: kinds of research study design

Observational
Studies

Analytical Studies
Descriptive Studies
(Comparison Group
(No Comparison Group)
Present)

Cohort Case- Cross-

control sectional Case Report Case Series Surveys
Studies Study Study
Figure 2: observational study designs

Disease
Exposed
No Disease
Populaton
Disease
Non-exposed
No Disease

Exposure Follow Up Out Come

Figure 3: Schematic design of cohort study

Case-control study is a retrospective study that means

Outcome of exposed to a drug opposite to cohort study/mirror image of cohort study,
Relative risk =
Outcome of unexposed group to a drug the study start with outcome and search for the risk factor
by taking case records. [2] This study includes case group
Incidence
Number of new cases during specified period (people with diseases) and control group (people without
= disease) as a comparison. The study initiates with
Total presons was observed in specified period outcome and look backwards to identify the exposure
Risk difference = outcome of exposed group – outcome of (risk factor) by history of cases taken from the medical
non-exposed group records (Figure 4) and it is also performed through the
conducting the interviews. [14] Case-control study is also
Retrospective cohort (Historical, Non-Concurrent) is named as: Historical study, [4] Backward looking, [9]
another kind of study, the investigator select old patients Retrospective/Retrolective study, [5, 10] Longitudinal study,
from the case records or registry and he observes them for [11] Case-reference study. [10]

outcome. The direction of observation is always forwards For example, the cases with peptic ulcers and controls
in cohort studies. [4, 5] without peptic ulcers and looks back there history whether
they exposed to NSAIDS or not. The case-control studies
II. Case-control Study are widely used to assess the safety of drugs. Compare to the

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Cases People With Disease

Case History/
Registry
People Without
Controls
Diesease

Exposure Backward Look Out Come

Figure 4: Schematic design of case-control study

Past Present Future

Cross-Sectional Study

Prospective Cohort Study

Retrospective Case-Control Study

Randomized Control Study

Time

Figure 5: Time relationship of different studies

cohort study, case-control studies are easy to conduct and population. So it is ideally apt to measure the prevalence. [9,
takes less time and lesser cost. Disadvantages include 12] Cross sectional study also named as: Prevalence study, [4,

susceptible to bias (selection bias and information bias), 5, 13] Instantaneous study, [4, 13] Simultaneous study, [4, 13]

case-control study not appropriate when the outcome is Snap shot study, [13, 14] Transversal study. [15]
not unknown. [9] Odd ratio is the risk estimator in case- Cross sectional studies are conducted through surveys,
control study. It can also used in randomized control trails, database analysis or medication chart reviews. Census is
cohort studies to estimate risk. Odd ratio is calculated using the perfect example for cross sectional study. [4, 13]
the formula as below. [12, 13] Advantages include data available readily, good for
assessing the prevalence, follow up not necessary, fast and
a c ad inexpensive. And disadvantages include not suitable for
Odd ratio = × =
b d bc acute disease, no comparison group, susceptible to bias and
Where, a = number of persons exposed and with causality cannot be determined. [4, 5, 14] Prevalence
disease, b = number of persons exposed but without calculated by the following two formulae as below: [3]
disease, c = number of persons unexposed but with disease,
point prevalence =
d = number of persons unexposed and without disease, a,
Cases during a given specified point of time
c = total number of persons with disease (cases), b, d = total × 100
number of persons without disease (controls). total population during the period

III. Cross Sectional Study Period prevalence =

Cross sectional study is a study in that measures exposure cases during a given time period
× 100
and outcome at the same time in randomly selected total population during the same time period
population, that means ask the questions and get the
answers regarding exposure and outcome (determines Different Analytical Observational Hybrid Study
presence or absence of exposure and presence or absence Designs
of disease outcome for each individual), follow up is not Nested Case-control and Case-cohort Study: Nested case-
necessary for this study (no time sense, people examine control study or case-control in cohort study means cases
only one point of time). Cross-sectional study is useful to and control groups are elected from the cohort study. That
assess presence (prevalence) of disease in the selected means which are developed diseases as cases and which

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not developed diseases are as controls will be taken from country. This study is also useful to compare the data
case–control study. Nested case-cohort is also same as the region to region and country to country. For example,
nested case-control study. But, in this study cohort is taken New Zealand mortality increased with anti-asthmatic
randomly as a control and as a comparison. Cases may drug use, using statistical data of country. So, with that
present in cohort to be analyzed. [4, 5] they can identify incidence and prevalence in the country.
This study is depended on individual data if not available
b. Descriptive Study it leads the bias, called as ecological fallacy or aggregation
I. Case Report bias. [1, 5, 13, 19]
Case report is usually reports of events and individual
patient experience on drug exposure and outcome Biases in Observational Studies
observed in the single patient. Case reports are useful to set Bias or errors in the study causes the results inaccurate.
hypothesis for causation of an event. So it gives alarming The different biases include,
signal for other health care professionals on the event. [3] But
case report should be details of a rare disease, abnormal 1. Confounding Bias
drug reaction and ADRs. This rare events are have been Confounder is an additional risk factor or variable related
collected by the WHO, Uppsala monitoring center. [16] with exposure/disease that affects the outcome (other than
For example, case report on Thalidomide that causes to the risk factor). For example, alcohol and smoking; people
human Teratogenicity, later helped in to confirm that could who drink alcohol lead to the cancer. We know that
produce fetal abnormalities. The case report of smoking is also cause cancer. Some people drink alcohol at
Hypertricosis with the use of Minoxidil for hypertension the same time smoking too. Thus, smoking is the
also helped in developing Minoxidil as a topical preparation confounder between the alcohol and cancer. [10, 11, 13]
for baldness. [13]
2. Selection Bias
II. Case Series Selection bias is a problem in observational studies why
Case series are collection of case reports (multiple because in which groups are not randomization. Groups
patients with the same findings), who have a similar assigned as their wish. If groups are not balanced based on
single exposure or similar outcomes later the treatment; it the characteristics, we get irregular and unbalanced
may be based on either exposure or outcome. Event, groups, ultimately it effects on results. [10, 11, 13]
happened in the patients is confirmed by the more case
reports availability that means case reports of common 3. Information Bias
events, stronger will be the confirmation. Case series are The inaccurate information collected from subjects, results
mainly useful to find out the ADRS. It is also named as open in giving the wrong outcome. This inaccurate information
trail. [17] may come from the either subjects or personnel. [10]

III. Surveys 4. Protopathic Bias

The term survey means the collection of information from a The electing of a diseased person but not recognized during
group. The types of information include – Demographics, commencing the study, disease may appear after the drug
Attitudes, Opinions, Knowledge and Behaviors. The intake cause to misleading of the study. For example,
population may be patients, learners, researchers and gastric carcinoma and anti-ulcer drug Cimetidine. Actually
colleagues. And this survey goes between surveyors and the Cimetidine, it is not causes to the gastric carcinoma. [13]
respondent, it may be done through face to face, telephone
or with no personal interaction that means through the 5. Measurement Bias
postal, fax, web survey. The collection of information is If many groups are involved in the study, the personnel
through asking questions that is why questionnaires must measuring, instruments used are the two major problems
be well designed. There are several steps involved in to arise this bias. [13]
conduct the survey as follows:
 Frame the research question Bias Controlling
 Develop the survey 1. Matching/ Stratification/ Restriction
 Pilot text of the survey (a small survey in the targeted Matching, stratification (Strata means groups or blocks)
population helps in the researcher to frame the and restriction (Allowing the same age group subjects to
questions, modifications or removal in questions. This is the study) are the strategies to control the bias. Bias
done before commencing the study.) [18] controls by the matching the patient groups and the
control groups with respect to the base line
IV. Ecological Study characteristics (age, sex, etc...). For example, if we take 54
Ecological study is one kind of descriptive study. years old cirrhosis patients, as the same way we should
Ecological study is also named as Correlation Study, take 54 years old normal subjects as a control group. If we
Analysis of Secular Trends and Aggregated Data. It is take 40 – 50 years old patients they should compare with
based on existing statistical data is compared with the 40 – 50 years old controls. Age is a common confounder in
prevalence and incidence of diseases in the populations or these studies. [10, 11]

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Experimental
Studies

Randomized Study
Non-randomized Study
(Partcipants Randomly
Allotted) (No Randomization)

Controlled Study
Uncontrolled Study Controlled Uncontrolled
(Control Group In The Study Study
Study) (No Control Group)

Parallel Cross Over

Figure 6: Experimental study designs

Interventonl Group Regular Follow Up Out Comes Measured

Randomized
Population
Control Group Regular Follow Up Out Comes Measured

Figure 7: Schematic diagram of randomized controlled study

2. Experimental Study (Interventional Study) interventional group receives interventional drug and
Experimental studies are not as the observational studies control group receive either old drug or placebo (Figure 7).
there is an intervention taken place. Thus, it is also named For randomized controlled study is also named as:
as interventional study. The national institute of health  Clinical trail
(NIH) defined an interventional study as individual in  Gold standard study.
which “participants receive specific interventions
according to the research plan created by the investigators. Why Use Controls and the Concept Placebo as Control?
These interventions may be medical products, such as The comparison must be needed between new
drugs or devices; procedures; or changes to participants Interventional drugs and older drugs, then only we know
behavior”. [14] Experimental study designs further classified which one is better and safe for the patients, otherwise we
as follows based on the randomization. cannot say which is safe to treat. [9] And placebo should use
as a control if no drug present to treat a disease. Placebo is
The Concept and Importance of Randomization an inactive medication having no pharmacological action,
Randomization is the core of the experimental study and it but sometimes person may feel better due to the
means randomly electing of eligible individuals from a psychological effect of receiving some medication. [9]
population. Randomization done by the tossing of coin, Randomized study further divided into two types, one is
random number tables, computer generated numbers. parallel design (Figure 8) and another one is cross-over
Tossing a coin gives 50:50 chances. Random number table design (Figure 9). It is classified based on the treatment
is a good technique and for that alternative is computer receiving of two groups. The parallel study is a simplest
generated numbers, bias is not involved in these studies study and widely used study. In this study interventional
because of randomization. [9] However, randomization group receive interventional drug and control group
should done by the pharmacist, if others involved like receive old drug or Placebo throughout the study. [10, 11]
researchers it will lead to influence on trail and bias, finally But, in cross-over study both groups receive both
the results are unreliable. [20] drugs. How means, until the washout period or cooling
period interventional group receive interventional drug
a. Randomized Study and control group receive old drug or placebo, after the
I. Randomized Controlled Study washout period the treatments are exchanged then
Randomized control study design is the highly reliable interventional group receive old drug or placebo and
design and it is high level evidence to practice health control group receive interventional drug, that means
profession. [14] As name indicates, control group is present interventional group becomes control group and control
as a comparator to the interventional group. In this study group becomes interventional group. [5, 9, 11]

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Interventional Drug
Interventional Group Out Comes Measured
(New drug)
Randomized
study population
Control Group Placebo/ Old Drug Out Comes Measured

Figure 8: Parallel study design

Interventional Interventional Out Comes Wash Out Placebo/ Old Out Comes
Group Drug Measured Period Drug Measured
Randomized
Study
Population
Placebo/ Old Out Comes Wash Out Interventional Out Comes
Control Group
Drug Measured Period Drug Measured

Figure 9: Cross over deign

Interventonl Group Regular Follow Up Out Comes Measured

Non-randomized
Population
Control Group Regular Follow Up Out Comes Measured

Figure 10: Non-randomized controlled study

Blinding assist in bias elimination in the study II. Non - randomized Uncontrolled Study
participants, follow up examiners, treatment This study is also same as that of randomized uncontrolled
administrators, ancillary staff involved in the study. It can study but without randomization and control group.
be prevented at different levels by hiding or blinding or Outcomes measured finally after the collection.
masking. Blinding is three types based upon the persons
blinding in the study. Different Randomized and Non-Randomized Trails
 Single blinding ( patient alone) 1. Cluster Randomized Study
 Double blinding (patient and clinician) Cluster means group and this study itself consists subjects
 Triple blinding (patient, clinician and statistician) as randomization. The study goes on group wise, not on the
Without the blinding accurate results are not obtained. basis of individuals. Examples for group includes - Schools
Extra concentration of Clinicians, treatment administrators in a city, Villages, Religion, Ethnicity and Occupation wise in
and other personnel may possible on particularly some an area. This is the simple to randomize the participants by
patients who are receiving interventional drug. Blinding groups than individual. Even the results are done by group
process revealed after the entire study completed. not by individuals. [4, 5]
Unblinding may also do when benefit or harm is revealed in
groups. [9] 2. Latin Square Design
Latin square design helpful to study more than the one
II. Randomized Uncontrolled Study treatment simultaneously to understand the usefulness of
In this study there is no control group present only one
each treatment by the comparison. For example, four
group present with randomization. It is so weaker when
treatments namely – A, B, C, D. then Latin square is applied
this study compared with the randomized control study.
(four replications of each treatment) as follows and do
comparison. [10]
b. Non - randomized Study
I. Non - randomized Controlled Study A B C D
The study is same as that of the randomized control study B C D A
but without randomization. The control group receive C D A B
placebo or old drug and interventional group receive D A B C
interventional drug finally outcomes measured (Figure 10).
Sometimes hospital records data obtained from published 3. Factorial Randomized Study
literature can be used as a control group, such non- In this study, only one control group and two interventional
randomized or non-current studies named as historical groups are present. The results of each group comparing
control studies. with the control group. And with the help of this study we

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can assess at a time two factors (treatment and dosage b. Non-equivalent control group design
form). [9, 10] Time design, the study goes without control group and
requires only one experimental group. The variable is
4. Multi Centric Trails measured on experimental group by giving the
Research goes at a time in many centers by sponsored experimental treatment. So, due to the lack of control group
organization. They collect the data from the each group, we cannot identify whether the experimental treatment
combined as a single study and evaluated. All the data superior or not when compared with the existing drug.
pertaining to the study should sent to the sponsored Statistical comparison or mean is done through following
organization periodically, finally they done publication. the treatment group on the same variable. In Non-
Individual center has no rights to publish data equivalent control group design the study goes with control
independently at the any phase. [9] group. Both groups are intact groups and they pre-tested
and post-tested and finally made conclusions through the
5. Field Trails (Field Study) data collected. Assumption of equivalence regarding the
Field trails are an Interventional studies and field means study cannot be made between the groups (significant
other than the clinics. In this trails disease free population difference) and it is possible when pre-tested. If null
elected to aware and reduce the risk of development of hypothesis is acceptable, then the researcher can begin his
disease in the field. Field trails are of two types. [21] experiment on the assumption that he has equivalent
a. Individual level groups. Some may suggest analysis of covariance
b. Aggregated level (community trails) (statistical analysis) rather than the experiment. [5]
The trail done in communities (School, house hold,
community), thus they are named as community trails. PHARMACOEPIDEMIOLOGY IN INDIA
Especially the trails are being conducted with regarding to Pharmacoepidemiology came to India in late seventies,
the disease. The selection of disease is based on the but still there is no drastic improvement in research
researcher interest. In community, awareness camp goes studies. Indian researchers are interested to do mostly in
first; each people were interviewed and analyzed before conducting drug utilization studies and these studies are
conducting the study. After the one or two years later, useful to generate hypothesis, whereas no one is
their knowledge and behavior were assessed regarding interested in interventional studies. In India studies are -
the life style modification as well as blood pressure, classes of prescribing drugs, the number of drugs per
weight, plasma cholesterol measured. Face to face prescription, the number of fixed dose drug formulation,
interaction, direct counseling regarding disease and injectable and so on and there is no further step in studies
regarding life style modification are advantages of this even on drug utilization studies. Studies are not running
study; result in the decrease in the risk development of even by using internationally accepted measures such as
diseases and control of some chronic diseases in daily defined doses (DDD) is not done. It was showing that
community. [10, 21] lack of knowledge, laziness, apathy and unwillingness to
conduct the better study. Ultimately saying that Indians
6. Therapeutic Trails and Prophylactic Trails are restricting themselves to observational studies and to
Therapeutic trails nothing but the randomized control see Indians are not interested to do the interventional
trails in which interventional group receives interventional studies. [22]
drug and control group receives either old drug or placebo.
Finally, they compare the each drug for effectiveness as CONCLUSION
well as related to healing of the disease. Prophylactic trails The drugs are approved by performing trials within the
are same as therapeutic trails. Two groups are taken one as limited people and within short time. Thus, drugs after
prophylactic group (protected group) and another one as enter into the market, it become use vastly in the different
control (unprotected group). Prophylactic group is treated population and chances for arising the drug related
with prophylactic treatment and control is not. These two problems. The better way is to minimize drug related
groups are observed and results should be protected group problems, research study designs or
may cured from particular disease than the unprotected pharmacoepidemiological studies going to be helpful and
group. [10] the Pharmacists as a health care professional play a key
role in scientific progress regarding the safety profile of
7. Quasi Experimental Design drugs (unknown and unsuspected drug effects), disease.
Researchers do research sometimes on intact groups (the And generation of hypothesis is not enough, interventions
groups are already formed rather than the random are needed. So problems arise during usage of drugs by
selection). The groups are not electing randomly from the patients should detect and analyze the problem by
larger population, so it leads to wrong results at the final performing appropriate study design and ultimately help in
step and this is problem faced by the researchers during patient care.
conducting the study, but need to do the research. So, it is
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Inventi Rapid: Clinical Research Vol. 2015, Issue 3 8 2015 pcr 16325 © Inventi Journals (P) Ltd
[ISSN 0976-383X] Published on Web 19/06/2015, www.inventi.in

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