An Introductory Presentation to Clinical Research. A go through from this presentation will give you a brief and clear introduction about Clinical Research.

1. Dr. SUMAN BAISHNAB

2. INTRODUCTIONINTRODUCTION
Why Do Research Studies?
 To collect data on usual and unusual events, conditions, & population
groups
 To test hypotheses formulated from observations and/or intuition
 Ultimately, to understand better one’s world and make “sense of it”
Why Clinical Research Needed?
 The answer is “UNMET MEDICAL NEEDS”
 New diseases - (Bovine Spongiform Encephalopathy; AIDS, Alzheimer’s,
Obesity)
 low efficacy - (dementia, cancer)
 side effects - (antidepressants, antipsychotics)
 Downstream health costs - (Alzheimer’s; spinal injury)
 Cost of therapy - (Viagra, Interleukins)
 Costs to individual/country - (depression)
 Sustain industrial activity - (pharmaceutical industry employs thousands
and makes a massive contribution to overseas earnings; patent expiry)

3. INTRODUCTIONINTRODUCTION…
Three main types of Clinical Research:
Observational Studies:
 Groups are studied & contrasts made between groups
 The observed data collected are analyzed
Analytic Studies:
 Also called Experimental
 Study the impact of a certain therapy
 Ultimately the investigator controls factor being studied
Clinical Trial:
 Considered the “true” experimental study
 “Gold Standard” of clinical research
 Often a prospective study that compares the effect and value of an
intervention against a control in human subjects
 Thus, The purpose of clinical research is to create knowledge needed to
improve health care. Without such knowledge, action for health care may
be impossible, wasteful, expensive or harmful because it will have no
logical or empirical basis

4. CLINICAL TRIALSCLINICAL TRIALS
What Are Clinical Trials?
 Systematic study of new drug therapy or medical intervention performed
in humans
 Try to answer scientific questions and find better ways to prevent,
diagnose, or treat disease
 To discover or verify:
 Pharmacodynamics (how it works)
 Pharmacokinetics (what happens to it)
 Therapeutic effects (efficacy)
 Adverse reactions (safety)
 Form the basis of changing current medical practice
Why Are Clinical Trials Important?
 Clinical trials translate results of basic scientific research into better ways
to prevent, diagnose, or treat disease
 The more people take part, the faster we can
 Answer critical research questions
 Find better treatments and ways to prevent disease

5. CLINICAL TRIALSCLINICAL TRIALS…
What Are the Different Types of Clinical Trials?
 Treatment
 Prevention
 Early detection/screening
 Diagnostic
 Quality of life/supportive care
Treatment Trials:
 What new treatments can help people with a particular disease?
 What is the most effective treatment for people with that disease?
Prevention Trials:
 Evaluate the effectiveness of ways to reduce the risk of a particular disease
 Enroll healthy people at high risk for developing that disease

6. CLINICAL TRIALSCLINICAL TRIALS…
Prevention Trials:
 Action studies (“doing something”)
 Agent studies (“taking something”)—also called “chemoprevention
studies”
Early detection/screening Trials:
 Study ways to reduce the risk, or chance, of developing a disease
 Represents a unique challenge because it involves subjects without a
diagnosis of disease
 sometimes with people who had disease and want to prevent the
recurrence of the diseases
 Can be done for cancer, diabetes, hypertension, mood disorders, etc.
E.g.: The role of selective estrogen receptor modulators (Tamoxifen) in
the prevention of breast cancer: comparison of the clinical trials

7. CLINICAL TRIALSCLINICAL TRIALS…
Diagnostic Trials:
 Study tests or procedures that could be used to identify a disease more
accurately and at an earlier stage
 Diagnostic trials usually include people who have signs or symptoms of
a particular disease
 Can be done for cancer, tuberculosis, myocardial infarction
Quality of life/supportive care Trials:
 Study drugs to reduce side effects from chemotherapy and other
primary treatments
 Problems encountered by patients, such as fatigue, nausea, pain,
weight loss, a risk for secondary disease conditions, and depression can
be studied
 Other supportive care studies look for beneficial effects of nutrition,
group therapy, and other approaches
 Can be done for cancer, anemia, depression, diabetes, hypertension,
rheumatoid arthritis, etc.

8. DEFINITIONS AND TERMINOLOGY USEDDEFINITIONS AND TERMINOLOGY USED
IN CLINICAL RESEARCHIN CLINICAL RESEARCH
Glossary Group of CDISC (Clinical Data Interchange Standards
Consortium) published version.3.0 glossary of clinical trial terms
Absorption: The process by which medications reach the blood stream when
administered other than intravenously, for example, through nasal membranes
Action letter: An official communication from FDA to an NDA sponsor
announcing an agency decision. See approval letter, approvable letter, not-
approvable letter
Administrative record: A document/ attributed collection of data detailing or
recording an aspect of a study or its associated protocol that is not required by a
regulatory agency
.............
Ref: www.cdisc.org/glossary/CDISCGlossaryV5.pdf