These slides re prepared to give the basic knowledge about the planning and execution of clinical trials

1. RESEARCH SUPPORT INCLUDING
PLANNING AND EXECUTION OF
CLINICAL TRIALS
Pooja Anothra
Asst. Professor
IEC group of institutions

2. RESEARCH SUPPORT INCLUDING PLANNING
AND EXECUTION OF CLINICAL TRIALS
A product manager's most critical task is preparing a project
plan for a global clinical trial. But what constitutes a
successful plan, and how do you execute it in a landscape
that has become increasingly more complex?
Let's start with the basics: The successful execution of a
clinical trial means the project is finished on time, on
budget, and has a high level of quality. It only figures
then that these objectives should be clearly defined before
initiating any project.
The main purpose of planning is to anticipate all possible
actions that will take place throughout the project.

3. The main obstacle a project team faces is the defining of
the critical path. In other words, all tasks that need to
be carried out in parallel and sequentially need to be
understood—when should they be completed to
achieve clinical trial milestones; how should those
activities be performed in order to successfully
complete them; what is the end goal; and what are the
organization's strategies? This needs to be structured in
such a way that it can be used by other project teams
that have to perform clinical trials.

4. The start-up phase of a clinical trial needs a road map
that includes the following:
*Study planning
*Site selection
*Site qualification
*Local EC/IRB submissions
*Ministry of Health submissions
*Supplies importation process
*Site regulatory package approval
*Clinical supplies at the study site.

5. 1. Define all the activities to be done in parallel and
sequentially for each one of the steps (critical path),
including the time needed to perform each activity.
A good understanding of the entire process and sub-
process protects against forgetting any of the critical
steps.
New Venues
For example, you may decide to generate a sub-
process for site selection activities, and then define
the critical path to select sites for the clinical study.

6. 2. Site selection:
a. Request for site identification (2 working days).
b. Feasibility questionnaire development (5 working
days).
c. Develop site identification strategy (2 working
days)
d. Create the preliminary potential site identification
list (1 working day)
e. Develop final potential site identification list (1
working day)
f. Contact sites. Collect the information (10 working
days)
g. Identify sites for qualification (1 working day).
h. Investigator database update (1 working day)

7. 3. Once the project plan template is developed and
implemented, the project manager should customize
the tool according to the study-specific requirements.
4. Then, lock the planning by saving the baseline. The
baseline should be saved immediately after the
initiation of the clinical trial activities. This allows for
an evaluation throughout the project of any deviations
from initial expectations. It is very important that
information be updated on a regular basis, with the
accruals in real time and shared with the project team
accountable for the deliverables as well as with senior
management.

8. 5. A risk management plan should be followed in
parallel with clear mitigation strategies and
contingency planning (the activation of back-up
countries, or the selection of additional sites). In this
way, the delays are predicted with sufficient time to
resolve them efficiently. This also allows you to
anticipate and address the impact of changes on the
planned dates.
The success of any project is in the planning
phase. If all the steps to achieve the goals in the
project are defined at the outset, including timelines,
and they are understood by the project team, the
chances of failure are much lower.

9. The way clinical trials are conducted has changed
significantly in the last 20 years. The turning point
was the creation of the GCP guideline and the
globalization of clinical research. Running a clinical
trial today has become a highly complex endeavor.
The biopharmaceutical industry is under intense
pressure to develop new medicines due to patent
expiration of several marketed products. The focus
on innovation is one of the drivers for the increase in
the number of clinical trials that results in more
studies of fewer compounds.

10. THANK YOU