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1. Types Of Clinical Trials And Its Significance
Clinical trials means medical research studies involving people. They are divided into different
stages, called phases. The earliest phase trials might focus at whether a drug is safe or the side
effects it causes. A later phase trial aims to test and compare whether a new treatment is better than
existing ones.
Types of Classifications:
In one way of classification it is based on the behavior of researches:
• Clinical observational study: The investigators observe the subjects and measure their
outcomes. They don't actively manage the study.
• Intervention study: The investigators give the research subjects a particular medicine to
compare the treated subjects with those receiving no treatment or the standard treatment.
Based on inferences the investigator measures the health changes if any.
Another method of classification is based on their purpose. The U.S. National Institutes of Health
(NIH) organizes trials into five different types:
• Prevention trials : It attempts to find better ways to prevent diseases in people who were
never susceptible or to prevent a disease from returning. These approaches include
medicines, vitamins, vaccines, minerals, or lifestyle changes.
An example of a prevention trial is the IBIS 2 breast cancer prevention trial.
• Screening trials: The best way to detect certain diseases or health conditions. The study of
causes and patterns of disease is called epidemiology. Most epidemiological studies are
observational studies.
There are three types of observational studies – cohort studies,case control studies
and cross sectional studies.
• Diagnostic trials : To find better alternative for diagnosing a particular disease or
condition. For example to study tests or procedures that could be used to identify cancer
more accurately. Diagnostic trials usually include people who have signs or symptoms of the
disease.
• Treatment trials : It efforts testing experimental treatments, new combinations of drugs, or
new approaches to surgery or radiation therapy. They are conducted with diseased people as
test subject. They aim answering specific questions about and evaluate the effectiveness of a
new treatment or a new drug or a new approach of using a standard treatment.
• Supportive care trials : It attempts find the quality of trials. It aims finding ways to
improve the comfort and quality of life for individuals with a chronic illness.

2. • Expanded access trials : Also known as compassionate use trials. It provides partially
tested, unapproved therapeutics to a small number of patients who have lost all realistic
options. Usually this involves disease for which no effective therapy has been yet approved.
A third classification is whether the trial design allows changes based on data accumulated during
the trial.
• Fixed trials : It considers existing data only during the trial's design, and does not modify
the trial after it begins and even not assess the results until the study is complete.
• Adaptive clinical trials: This use existing data to design the trial and then use inferred
results to modify the trials as it proceeds. Modifications include dosage, sample size, drug
undergoing trial, patient selection criteria and "cocktail" mix. Adaptive trials often employ a
Bayesian experimental design to assess the trial's progress.
Phases of clinical trials
Clinical trials are a kind of clinical research designed to evaluate and test new interventions such as
psychotherapy or medications. Clinical trials are often conducted in four phases. The trials at each
phase have a different purpose and help scientists answer different questions.
Phase Aim Comment
Phase
0
Pharmacodynamics
and pharmacokinetics
in humans
First-in-human trials.
Single sub therapeutic doses of the study drug or treatment
are given to a small number of subjects (10 to 15) to gather
preliminary data on the agent's act in the body and what the
body does to the drugs.
Phase
1
Safety screening
Testing within a small group of people (20–80) to evaluate
safety, determine safe dosage ranges, and begin to identify
side effects. Phase 1 trial can't detect all the side effects as it
might happen with only a handful of people.
Phase
2
The drug's efficacy is
established ,usually
against a remedy
Testing with a larger group of people (100–300) to see if it is
effective and to further evaluate its safety. Gradually the test
size is increased to find out most common side effects.
Phase
3
Final confirmation of
safety and efficacy
Testing with large groups of people (1,000–3,000) to confirm
its effectiveness, monitor side effects, compare it to
traditional treatments and collect information that will allow
it to be used safely.
Phase
4
Safety studies during
sales
Post marketing studies depict additional information,
including the treatment's risks, benefits, and optimal use.
CRB Tech Solution's Clinical Research review is sufficient to make you consider and take up a
career in this field.