What is clinical research

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Clinical research is a systematic investigation that involves the study of human participants to evaluate the safety, efficacy, and effectiveness of medical treatments, drugs, devices, and interventions. The primary goal of clinical research is to generate robust and reliable evidence to inform healthcare decisions, improve patient care, and advance medical knowledge. It encompasses a wide range of activities and studies, including clinical trials, observational studies, and other research methodologies

Health & Medicine

Welcome
CLINICAL RESEARCH
Mohammad Faizan Farooqui
B.pharm
Student ID -
10/18/2022
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CONTENTS OF TABLE
➢ INTRODUCTION
➢ PURPOSE OF CLINICAL RESEARCH
➢ TYPES OF CLINICAL TRAILS
➢ STEPS PRIOR TO HUMAN TRAILS
➢ PHASES OF CLINICAL TRAILS
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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.
❖ A clinical trial (also clinical research) is a research study in human volunteers to
answer specific health questions.
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Definition:

PURPOSE OF CLINICAL RESEARCH
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Understan
ding
Diseases
Developing
Treatments
Purpose Of
Clinical
Research
Improving
detection
&Diagnosis
Ensuring
safety
Enchancing
Health and
Quality of
life
Informing
Medical
Decisions

TYPES OF CLINICAL TRAIL
Interventional trails:
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Interventional trials determine whether experimental treatments or new ways
of using known therapies are safe and effective under controlled
environments.
Observational trials:
Observational trials address health issues in large groups of people or
populations in natural settings.

PHASES OF DRUG DEVELOPMENT
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Identification of new
molecule
Screening of biological
activity/experiment
design
Pre-formulation
Formulation
Stability testing.

STEPS PRIOR TO HUMAN TRAILS
➢ A study to test a drug procedure or other medical treatment in
animals. Preclinical studies are required before clinical trials can be
started.
➢ Investigational new drug application (IND) or Investigational device
exemption (IDE) for the FDA
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Preclinical (nonclinical):

PHASE OF CLINICAL TRAILS
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PHASE OF CLINICAL TRAILS
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Phase-1:
❑ First studies in human
❑ Usually involve small groups of healthy volunteers or patients with
particular disease - 20 - 80.
❑ Short duration.-Provide preliminary safety and tolerability evaluation
❑ .Establish pharmacokinetic and pharmacodynamic profiles of the drug

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Phase-4:
❑ Conducted after marketing approval of drug.
❑ Post marketing studies sometimes designed to differentiate the
drug from competitors and demonstrate health economic
benefits.
❑ Include post registration usage studies and post-marketing
surveillance studies.

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