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Clinical Trial Story

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by

Mengjie Zhu

on 1 May 2014

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Transcript of Clinical Trial Story

Each clinical trial in the U.S. must be approved and monitored by an
Institutional Review Board (IRB)
.

Besides protocols, IRB also reviews
Informed Consent Form
to ensure the rights and safety
of the participants.

Clinical Trial Story

Hizer hires a
Clinical Research Organization (CRO)
to run clinical trials for them.
CRO Outsourcing?
Clinical Research Organization (CRO)
provides research services on a contract basis. It assumes sponsor's responsibilities as requested.
Monitor
Hizer assigns John, who has been working in the clinical industry for five years, to be the
Monitor
.
His job is to review trial data for accuracy and completeness.
He came to Hizer, the largest drug company in the city. They decided to invest in Dr. Franklin's research and producing a new drug for depression.

They call it
RELAS
.

Study Protocol
Looking for an Investigator Site
Get prepared for the IRB review
Before the First Visit
The CRO has to design
Case Report Forms (CRF)
to collect required data during subjects' visits.
Clinical research is conducted according to a plan known as a
protocol
.
A protocol is carefully designed to safeguard the participants’ health.
A Protocol describes:
To run clinical trials, the CRO has to select an
Investigator Site
, where physicians and staff can conduct the protocol, evaluate patients, and collect data.
The CRO also has to find a
Principal Investigator (PI)
, who is normally a doctor, to lead the clinical study.
The
Clinical Research Coordinator (CRC)
works with PI to perform all the trial activities with the subjects.
A Huge Wave of Subjects is Approaching...
Analyze the Data
Getting Approved
is not "The End"
Once all the subjects' data has been collected, the
Data Manager
and
Statisticians
start analyzing the data and then include the results in the
Clinical Study Report
.
Waiting for FDA Approval
Hizer submits the clinical study report together with all the other information and data required by FDA to approve Relas for marketing.
As the Sponsor,
Hizer has to develop RELAS, test it, and provide data to FDA for marketing approval.
Once FDA approves a drug, the post-marketing monitoring stage begins. Hizer has to submit periodic safety updates to FDA.
Informed Consent Form
Subjects have to sign the Informed Consent Form before participating in a clinical trial.

The form includes the key facts about a clinical trial, such as its purpose and required procedures. It also explains risks and potential benefits. The form has to be approved by IRB before recruiting subjects.
Objectives of the trials
“Every night, 20 new people suffer
from depression.” Dr. Franklin said.
"On a good night, 30 people."
Then he frowned.
"It's time to do something."

Many people in the city volunteer in the clinical trials.
Who is eligible to participate
Details about procedures, medications, and dosages
What information will be gathered
Full transcript