Clinical

Research
&
Trial
Snayhil Rana
 Relevant Extramural SOP: Adverse Events Reporting Requirements

Clinical Trial Safety Monitoring and Reporting Requirement

After peer review

NIAID commits funds.

Before enrolling patients

PI details safety monitoring
organization and procedures
including assessing and
reporting adverse events.
PI sends info to PO for approval.

PO review Yes, concerned

Does PO have concerns about PO sends revised plan or
patient safety or other issues? other comments to PI.

No concerns  Approval
PO approves details.

Serious adverse events IRB, FDA, and NIAID

Patients can be enrolled
after IRB approval.
During a clinical trial
PO monitors compliance with
monitoring plan.
address DSMB and
PI provides IRB and others
SAE reports
reports of serious adverse
events following PO must email or fax PI
NIAID Clinical Terms of Award Guidance within 10 days and send
. official letter within 30
For multi-site trials, PI also days of receipt.
sends DSMB summary NIAID can terminate award
reports to all IRBs and or take other action if PI
program officer. does not comply with
monitoring plan.
 The Drug Development and Approval Process
Preclinical Clinical Trial Post Clinical Trial Total Years for
Testing Drug Approval

Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7

Laborator File IND Phase 1 Phase 2 Phase 3 File BLA FDA
y/Preclinic Application /NDA with Approval
al Testing with FDA FDA

Trial Size 15 -30 People 20-100 People 100 – 1000 Several

People Hundred to
Several
Assess
Thousands
Safety and
People
Biological
activity in
Purpose the Determine Evaluate Determine Review
Laborator Obtain FDA Inform the
What dosage effectiveness , whether the Process /
y and in approval to FDA of
is safe , how Look for side new Approval
animal begin Phase 3
treatment effect treatment (or (Sometimes
model clinical data which
should be new use of also called
testing in support
given treatment ) is Phase 4 Trial )
Human drug safety
a better
after and better
alternative to
Promising performanc
Current
result in e over
Standard
Laboratory current
All standard
Anticancer treatment
Drugs
(Average 4.4 8.6 Years 1.4 Years 14.4 Years
number of
years ) Years
All Drugs *
(Average
number of 3.8 10.4 Years 1.5 Years 15.7 Years
years ) Years

Tools/
Remarks