August 2024 SOCRA Source Journal - Journal - Page 38
either ‘no comment,’ ‘notice of Figure 3. Clinical Figure
Trial Phases
3. Clinical Trial Phases
clinical hold,’ or ‘clinical hold.’ If
there is no comment, the sponsor
can proceed with the clinical
trial. A clinical hold could delay
the initiation of an early phase
trial on the basis of information
submitted in the IND. FDA would
issue a clinical hold if:
• Subjects are/would be
exposed to an unreasonable
and signi昀椀cant risk of illness
or injury
• Investigators are not quali昀椀ed
• The Investigator’s Brochure
is misleading, erroneous, or
beyond operationalizing the
in the form of outsourced
incomplete
clinical
protocol.
pharmaceutical research
• The IND does not contain
services (for both drugs and
suf昀椀cient information to
16
Key
sponsor
obligations
once
medical devices).
CROs must
assess the risks.
the FDA has approved the IND
act in the best interest of the
are preparing annual reports and
sponsor in supporting the
A clinical hold for Phase II or III
safety reports and conducting
management of the clinical
is the same as a clinical hold for
monitoring throughout the
research sites that will be
Phase I. The FDA would issue
clinical trial.
recruiting research participants.
a clinical hold if the protocol or
While the sponsor has the
study design is insuf昀椀cient.
Clinical Trial Management
ultimate responsibility for the
clinical trial, contracts and
As previously mentioned,
IND content and format
Transfer of Obligations (TOO)
clinical trials include Phase I, II,
requirements are:
documents allow the CRO to
and III, along with accelerated
effectively and legally act on
1. Cover Sheet (FDA Form1571)
development, treatment IND,
behalf of the sponsor. CROs
and parallel track IND trials.
2. Table of Contents
range from large, international
Phase I trials test a drug in
3. Introductory Statement
full-service organizations to
humans for the 昀椀rst time to
4. General Investigational Plan
small, niche specialty groups.
determine its safety and dosage.
5. Investigator’s Brochure
They can help their clients move
These studies involve 20 to 100
6. Protocol
a new drug or device from
healthy human volunteers.
conception to FDA approval for
7. Chemistry, Manufacturing,
and Controls data
marketing without the drug’s
In Phase II clinical trials, designed
sponsor having to maintain a
8. Pharmacology and
to evaluate the new drug’s
staff for these services.
Toxicology data
effectiveness and side effects,
researchers give the new drug to
9. Previous Human Experience
Some examples of functions
100 to 300 patients. In Phase III
10. Additional Information.
outsourced to CROs
trials, researchers give the new
include clinical monitoring,
drug to 1,000 to 3,000 patients
Sponsors may choose to manage
statistical analysis, data
to verify its effectiveness and
the clinical trial in-house or hire
management, medical writing,
monitor long-term use. Longa clinical research organization
pharmacovigilance, and
term monitoring identi昀椀es sideor contract research organization
project management. The
effects that may not have been
(CRO) to do this. If the sponsor
sponsor-CRO relationship is a
prevalent in the 昀椀rst four or 昀椀ve
hires a CRO, the sponsor still
partnership designed to ensure
years of using a drug during
oversees the clinical trial,
that the functions of the clinical
Phase I and II trials (Figure 3).
including the asset development
trial are being conducted.
team, stakeholder management,
Some pharmaceutical or
A CRO is a service organization
and governance for the protocol.
biotechnology companies might
that provides support to
CROs have limited visibility
only outsource one or a few
the pharmaceutical and
functions, whereas others might
biotechnology industries
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