The typical clinical trial lifecycle can be broken into several parts, each with unique
aspects regarding the biostatistical requirements
TRIAL PLANNING
TRIAL CONDUCT
Strategic planning:
implications of desired
label on endpoints and
trial design
Blind data review
for accuracy and
completeness
Protocol development
and review: e.g. sample
size calculation,
randomization,
endpoints and
objectives
Ongoing data review
to verify protocol
adherence
Development of
statistical analysis
plan (SAP) and tables,
figures and listings
(TFLs)
Regulatory review of the study protocol before study start
is conducted for study approval to ensure that:
• It is designed to meet study objectives while
ensuring that patient safety is protected.
• The endpoints are appropriate for the study.
• The sample size is appropriate for the
study objectives.
• The planned statistical analyses are
appropriate for the study objectives.
Similarly, all of these aspects are reviewed again once
the sponsor has conducted the trial, both to ensure that
the protocol and associated documents were followed as
well as to examine any additional unplanned issues.
Sufficient thought in the trial-planning stage reduces
the time required in developing later submissions and
responding to inquiries from regulatory authorities at
the trial submission stage. During the trial, constant
monitoring and addressing protocol issues as they occur
also reduces time and issues at study completion.
TRIAL CLOSEOUT/
ANALYSIS
TRIAL SUBMISSION
Interactions with
regulatory agency
Final analysis/TFLs
Composing a clinical
study report (CSR)/
integrated summary
of safety (ISS) and
integrated summary of
effectiveness (ISE)
Addressing regulatory
questions about the trial
As a result, the risk of a clinical trial failing to meet
study objectives is reduced. Many venture-backed
small- to mid-sized companies might not have had
experience running a clinical trial or interacting with
regulatory authorities, so they hire a contract research
organization (CRO) to assist them. It is critical that
the selected CRO has experience with all stages of the
trial lifecycle.
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Sufficient thought in
the trial-planning stage
reduces the time required in
developing later submissions
and responding to inquiries
from regulatory authorities
at the trial submission stage.
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