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Title: Clinical Trial
Description: Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments.
Description: Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments.
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Synopsis:
Some important terms regarding clinical trial
What is a clinical trial ?
History
Why are clinical trials important?
Benefits and risks of participating in clinical trials
Considerations before participating in clinical trial
Types of clinical trials
•
•
•
•
•
•
Intervention or treatment trials
...
Diagnostic trials
...
Quality of life trials
...
Participant’s are provided
information in their native language including purpose, duration, procedures, risk and
potential benefits
...
They are
used for physiological treatment
...
In
clinical trials, one group is given experimental drug whereas the control group is given as a
standard treatment for the illness or placebo
...
Single blind usually means that the research participants is not told of the treatment
assignment(s)
...
Randomized: Each study subject is randomly assigned to receive either the study
treatment or a placebo
...
What is a clinical trial ?
•
•
Clinical trials are set of tests in medical research and drug development
that generate safety and efficacy data for health interventions ( e
...
drug,
diagnostics, devices, therapy protocols)
...
Depending on the type of product & the stage of its development,
investigators initially enroll volunteers or patients into small studies and
subsequently conduct larger scale studies in patients that often compare
with others already approved for the affliction of interest
...
A full series of trial may incur sizable costs, and the burden of paying for all
the necessary people & services is usually borne by the sponsor, which may
be government organization or a pharmaceutical or biotechnology company
...
•
During the clinical trial, the investigators:
Recruit patients
Administrate the treatment(s)
...
•
These patients are the volunteers and they are not paid for participating in
clinical trials
...
The researchers send the data to the trial sponsors, who then analyzes the
pooled data using the statistical tests
...
( e
...
patients who have been diagnosed with Alzheimer’s disease)
Compare the effectiveness in patients with a specific disease of two or more
already approved or common interventions for that disease ( e
...
device A vs
...
therapy B
History
•
•
1
...
3
...
5
...
He laid out following rules and principles for testing the effectiveness of
new drug & medications:
The drug must be free from any extraneous quality
...
The time of action should be observed
...
The experimentation must be done in human body, for testing a drug on an
animal body might not be prove anything about its effect on man
...
Van Helmont’s proposal for a therapeutic trial of bloodletting for
fevers [1628]
• Dr
...
Patients will receive the best standard treatment
...
Obtain expert medical care facilities during trial
...
ii
...
RISKS
There may be unacceptable worsening of the illness condition if the
participant is randomly assigned to a control group and/or receive a
placebo
...
There may be unpleasant, serious or even life threatening side effects to
experimental treatment
...
The experimental treatment may not be effective for the patient
...
The protocol may require more time, including trip to study site, more
treatments, hospital stay or complex dosage requirements
...
Considerations before participating in clinical trials
•
•
o
o
o
o
o
o
o
o
People should know as much as possible about clinical trial and should
solve their queries to the members of health care team about it, the care
expected while a trial and the cost of trial
...
Inclusion criteria – the factor that allow some one to participate in clinical
trial are called inclusion criteria
...
• These criteria are based on the factors such as age, gender, the type &
stage of disease, previous treatment history and other medical
conditions
...
Historically women were excluded if she’s of reproductive age (ages 1845)
...
To safe guard these groups, special requirements such as:
•
•
•
Only parent can consent for minor
Consents must be in subject’s native language
...
Types of clinical trial
•
Intervention or treatment trials- Tests experimental treatments, new
combinations of drugs, or new approaches to surgery or radiation therapy
...
This
approach may include medicine, vitamins, vaccines, mineral or life style
changes
...
•
Screening trials- test the best way to detect certain diseases or health
conditions
...
Explore way to
improve comfort and quality of life for individuals with chronic illness
...
Methodology, statistical considerations & organization of planned trial
...
•
The protocol also gives the study administrators ( often a contract
research organization), as well as of physicians, nurses & clinical
administrators, a common reference document for site responsibilities
during the trial
...
2
...
4
...
6
...
Each phase of drug approval process is treated as a separate clinical
trial
...
If the drug passes through the phases, it will usually be approved by the
national regulatory authority for use in the general population
...
Pre-clinical studies
• Before pharmaceutical companies start clinical trials on a drug , they conduct extensive
clinical studies
...
• This phase of clinical trial help to assist pharmaceutical companies to decide whether a
drug has any scientific merit for further development as an investigational new drug
...
Phase 0
• First in human trial conducted in accordance with united state Food and Drug
Administration’s (FDA) 2006
• Phase 0 is also known as human micro dosing studies
...
of subjects (patients) of 10 – 15, to gather preliminary
data on the agents pharmacodynamics (what the drug does to the body) and
pharmacokinetics (what the body does to the drugs)
...
• This phase is carried out to rank drug candidates in order to decide which has best
pharmacokinetic parameters in humans to take forward in further development
...
Phase I
• A small group of 20- 100 healthy volunteers are recruited
...
• Phase I trial normally include dose-ranging, also called also called dose
escalation studies, so that the best & safest dose can be found and also to discover
that point at which the compound is poisonous to administrator
...
These studies are usually conducted in tightly controlled clinics called
CPUs (Central Pharmacological Units), where participants receive 24 hours
medical attention
...
• Volunteers are paid for their participation
...
• A small amount of participant, usually 3, are entered sequentially at a
particular dose
...
• Then the sample from the patients are collected & analyzed for
information
...
Hence, for the studies the volunteers are given 2 doses; one before the meal
(fasting condition) & one after the meal
...
Phase II
Once a dose range is determined, the next goal is to evaluate whether the drug
has ant biological activity or effect
...
• When the development process of new drugs fails, this usually occurs in phase
II trial
...
Phase II A - Designed to assess dosing requirements ( how much drug should
be given)
Phase II B – Designed to study efficacy (how well the drugs works at prescribed
dose)
• Some trials combine phase II A and Phase II B, and test both efficacy and
toxicity
...
PHASE III
•
•
•
•
•
•
Randomized trial on larger group of patients i
...
, 300-3000
...
Phase III trials are expensive, time taking and difficult to design and run
...
Once a drug has proved satisfactory after phase III trial, the trial results are
usually combined into a large document containing a comprehensive
description of the methods & results of human & animal studies,
manufacturing procedures, formulation details and shelf life
...
Randomization
Phase IV
• Also known as post marketing surveillance trial
...
• Harmful effect discovered by phase IV trial may result in a drug being no
longer sold, or restricted to certain use
...
Ethics
Rights of patient participating in clinical trial
3 ethical principles guide clinical research:
• Respect for Persons:
Persons: Treatment of person as autonomous
• Beneficence
Beneficence:: Potential conflict between good of society vs
...
• Justice
Justice:: Treatment of all fairly & all equally share benefits & risks
...
Participants’ rights protected by Institutional Review Boards [IRBs]
...
2
...
3
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Must follow guidelines & protocol
...
Title: Clinical Trial
Description: Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments.
Description: Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments.