Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use.

1. By Saumya Gupta

2.  CONTENTS
• Introduction
• Phases of Clinical Trials
• Preclinical Studies
• The Investigational New Drug Application (IND) Application
• Phase I
• Phase II
• Phase III
• Phase IV
• Institutional Review Board (IRB) or Independent Ethics Committee(IEC)
• New Drug Application

3. INTRODUCTION
Clinical research is a branch of healthcare science that
determines the safety and effectiveness (efficacy)
of medications, devices, diagnostic
products and treatment regimens intended for human
use. These may be used for prevention, treatment,
diagnosis or for relieving symptoms of a disease. Clinical
research is different from clinical practice.
A clinical trial is a type of clinical research study. A
clinical trial is an experiment designed to answer
specific questions about possible new treatments or new
ways of using existing (known) treatments.

4. PHASES OF CLINICAL TRIALS

5. PRECLINICAL STUDIES
A study to test a drug, a procedure, or another medical
treatment in animals. The aim of a preclinical study is
to collect data in support of the safety of the new
treatment. Preclinical studies are required
before clinical trials in humans can be started.
The two types of preclinical research are:
• In Vitro
• In Vivo

6. THE INVESTIGATIONAL NEW DRUG
(IND)
APPLICATION
Before a clinical trial can be started, the research must be
approved. An investigational new drug or IND application or
request must be filed with the FDA.
The United States Food and Drug Administration's
Investigational New Drug (IND) program is the means by which
a pharmaceutical company obtains permission to start human
clinical trials. Similar procedures are followed in the European
Union, Japan, and Canada.
The IND application may be divided into the following categories:
 Preclinical testing
 Manufacturing Information
 Investigator information
 Clinical trial protocols
 Other Information

7. Types of INDs:
• Commercial INDs
• Research or investigator INDs
• Emergency Use INDs
• Treatment INDs
• Screening INDs
An IND must also include an Investigator's Brochure
intended to educate
the trial investigators of the significant facts about the
trial drug they
need to know to conduct their clinical trial with the
least hazard to the subjects or patients.

9. FDA FORM 1571
The IND application, FDA Form 1571, provides the structure to present the
information about the proposed research. Form 1571 is used by all
applicants, commercial or research investigators, and there are several
sections that do not apply to a sponsor-investigator.
FDA FORM 1572
This form comprises the “Statement of Investigator.” The information
requested regarding the investigator’s qualifications and contact
information can often be met by an academic curriculum vitae, noting on the
form that the information is contained in the attachment.
FDA FORM 3674
The IND application must be accompanied by a certification that the
requirements of section 402(j) of the Public Health Service Act have been
met. United States Public Law 110-85 (FDA Amendments Act of 2007), Title
VIII, Section 801, requires registration of “applicable clinical trials.”

10. PHASE I
Study Participants: 20 to 100 healthy volunteers or
people with the disease/condition.
Length of Study: Several months
In most cases, 20 to 80 healthy volunteers or people
with the disease/condition participate in Phase 1. Phase
1 studies are closely monitored and gather information
about how a drug interacts with the human body.
Approximately 70% of drugs move to the next phase

11. PHASE II
Study Participants: Up to several hundred people with
the disease/condition.
Length of Study: Several months to 2 years
In Phase 2 studies, researchers administer the drug to
a group of patients with the disease or condition for
which the drug is being developed. Instead, Phase 2
studies provide researchers with additional safety
data.
Approximately 33% of drugs move to the next phase

12. PHASE III
Study Participants: 300 to 3,000 volunteers who have
the disease or condition
Length of Study: 1 to 4 years
Researchers design Phase 3 studies to demonstrate
whether or not a product offers a treatment benefit to
a specific population. Phase 3 studies provide most of
the safety data.
Approximately 25-30% of drugs move to the next
phase

13. PHASE IV
Several thousand volunteers who have the
disease/condition
Phase 4 trials are carried out once the drug or device has
been approved by FDA during the Post-Market Safety
Monitoring
A Phase IV trial is also known as postmarketing
surveillance trial, or informally as a confirmatory trial.
Phase IV trials involve the safety surveillance
(pharmacovigilance) and ongoing technical support of a
drug after it receives permission to be sold (e.g. after
approval under the FDA Accelerated Approval Program).

14. INSTITUTIONAL REVIEW BOARD
(IRB) OR INDEPENDENT ETHICS
COMMITTEE (IEC)
An independent body constituted of medical, scientific,
and non-scientific members, whose responsibility is to
ensure the protection of the rights, safety and well-
being of human subjects involved in a trial by, among
other things, reviewing, approving, and providing
continuing review of trial protocol and amendments
and of the methods and material to be used in
obtaining and documenting informed consent of the
trial subjects.
An IRB/IEC should safeguard the rights, safety and
well-being of all trial subjects. Special attention should
be paid to trials that may include vulnerable subjects.

15. NEW DRUG APPLICATION (NDA)
The NDA is an application that drug companies must
file in order to request regulatory approval for new
drugs from the FDA.
The application must include detailed evidence from a
series of clinical trials, each of which involves escalating
standards of scientific evidence.
Although most NDAs are approved by the FDA, it is
extremely difficult to develop a drug to the point where
an NDA can be filed.

16. THANKS