Clinical study in Research and some

important terms related to research

Presented by-
Dr Sanjay Ahari
Dr. Rani Khandelwal
JR-2
What is clinical research?
 Clinical research is the study of health and illness in people.
There are two main types of clinical research.
 1. Observational studies
 2. Clinical trials.
 1. Observational Research:- Researchers gather
information from people and compare changes over time.
 Observational studies do not test a medical intervention,
such as a drug or device, but may help identify new
treatments or prevention strategies to test in clinical trials.
2. Interventional studies are research studies that test a
medical, surgical, or behavioral intervention in people. These
trials are the primary way that researchers determine if a new
form of treatment or prevention, such as a new drug, diet, or
medical device (for example, a pacemaker), is safe and
effective in people. These trials are also called Clinical Trials.
 Often, a clinical trial is designed to learn if a new treatment
is more effective or has less harmful side effects than
existing treatments.
 Several variations of interventional study designs with
varying complexity, the most commonly used and possibly
the strongest design is a randomized controlled trial (RCT).
 Randomized controlled trials
 In an RCT, a group of participants fulfilling certain inclusion
and exclusion criteria is “randomly” assigned to two
separate groups, each receiving a different intervention.
Random assignment implies that each participant has an
equal chance of being allocated to the two groups.
 The term “controlled” refers to the presence of a concurrent
control or comparator group. These studies have two or more
groups – treatment and control. The control group receives
no intervention or another intervention that resembles the
test intervention in some ways but lacks its activity (e.g.,
placebo procedure, referred to also as “placebo-controlled”
trials) or another active treatment (e.g., the current standard
of care). The outcomes are then compared between the
intervention and the comparator groups.
Classification of RCT
(A)On the basis of study design:
1. Parallel:-In this type of research design, participants are
divided in to two groups. One group treated with
interventional medicine and other group treated with
standard medicine.
2. Cross over:- In this type of RCT, all participants receive all
the intervention, but in order in which the get the
intervention is randomized
3. Cluster:- The cluster RCT is an alternative trial design in which
the study participants are randomized as entire groups or “clusters”
rather than as individuals, as is the case with conventional RCTs.
Cluster RCTs can be used to measure the community effect of an
intervention, to review survival analysis of a population-based
treatment, or to evaluate an educational intervention.

4. Factorial:-If two (or more) interventions are available for a

particular disease condition, the relevant question is not only
whether each drug is efficacious but also whether a combination of
the two is more efficacious than either of them alone.
(B) Open and Blind RCT:-
1. Open RCT:- In this type of RCT, Trial participants are
known about intervention. Both Participants and
investigator are aware about which type of intervention is
carries out.
2. Blind RCT:- Participants are not known about the
intervention. Aim of blind RCT is to not effect the
intervention’s subjective assessment and decision .
Types of Blind Randomization Controlled Trial
a. Single :- Participant blind, only investigator known about
intervention .
b. Double:- Both participant and Investigation are not known
about intervention, only guiding committee or monitoring
committee is known
c. Triple:- Participants, investigator and guiding committee is
not known about intervention, this type of research is done
on National level.
Blinding aims to reduce the risk of bias that can be caused by
an awareness of group assignment. With blinding, outcomes
can be attributed to the intervention itself and not influenced
by behaviour or assessment of outcomes that can result purely
from knowledge of group allocation.
Important terms used in Research :

Research Question:- A research question is an inquiry that the

research attempts to answer. It is the heart of the systematic
investigation. Research questions are the most important step
in any research project. In essence, it initiates the research
project and establishes the pace for the specific research.
BIAS: any influence that may distort the results of a research
study and lead to error; the loss of balance and accuracy in the
use of research methods.
HYPOTHESIS: a proposition which research sets out to prove or
disprove: “experimental” where the hypothesis is a positive
statement, or “null” where statement contains a negative.
LITERATURE REVIEW: often the first step in the research
process, it is a review of the literature on and around the subject
of inquiry. Its main purposes are to avoid duplication, to identify
gaps in research and to place the researcher’s approach within the
work and approaches of others.
INFORMED CONSENT: giving potential participants
information about the study, especially in terms of factors that
might lead them to refuse to be in the study, before they decide
whether to participate. Institutional Review Board (IRB): a
committee of at least five members--one of whom must be a
nonscientist--that review proposed research and monitor
approved research in an effort to protect human research
participants.
PRIMARY/SECONDARY SOURCES: primary sources are
original firsthand records or materials relating to an event or
happening. They may include, for example, official minutes of
meetings, diaries, verbatim transcripts of interviews,
completed questionnaires or records of the results of
experiments. Secondary sources are accounts bases upon these,
which usually offer an interpretation, commentary, analysis, or
restatement of the primary sources. They can include, for
example, books, journal articles, and conference papers.
Endpoint :- In clinical research trial, endpoint generally refers
to objective of study.

Washout period:- It is defined as the time between

treatment periods. Instead of immediately stopping and then
starting the new treatment, there will be a period of time where
the treatment from the first period where the drug is washed
out of the patient's system. This period is usually used in Cross
over study.