The number of new clinical trials worldwide has increased significantly, forcing the biopharmaceutical industry to look for
new markets to conduct studies. Double-digit growth in the number of clinical trials conducted over the past five years in
regions like Central Eastern Europe, Asia, and Latin America is a clear indication of this trend.
The globalization of clinical trials has resulted in changes to clinical research regulations around the globe. Regulatory
authorities, particularly in emerging regions, have continued to introduce changes to existing clinical trial legislation
and requirements to ensure patient safety. This situation has created a more complex scenario for project managers who now
need to deal with several parties, fully understand updates to regulations, address increasing logistic and operational issues
(as well as import/export requirements of products and supplies), and grasp cultural differences.
This article will address how global clinical trials can be successfully planned and managed within this increasingly complex
environment.
Project plan creation
Figure 1. Chart includes a description of tasks and their predecessors, countries involved, and duration of activities.
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First, it is important to clarify what successful management means. This can be defined as meeting clinical trial objectives
in terms of timelines, quality, and budget. The key driver to successfully carrying out a clinical trial is to develop a comprehensive
project plan, which needs to be in place before starting any trial activity. The project plan has several components to manage
the quality and budget of the study, and to achieve the expected timelines with clear communication channels and defined roles
and responsibilities. This document should be the source for risk management and decision making.
The main purpose of planning is to anticipate all possible actions that will take place throughout the project. Therefore,
a diagnosis should be done for each aspect of the study to anticipate those actions and set realistic project objectives.
Previous experience in the areas subject to planning is required to determine realistic objectives.
One of the main areas to address when developing a project plan is creating a system for the project team in a type of template
format, which can be used for each new study, therefore avoiding rework. It is recommended to structure the knowledge of the
organization in a tool that can be utilized by any project team for any new clinical trial.
This concept changes the traditional way of planning because the responsibility remains to a great extent with the organization
and not just the project team. The organization is responsible for creating the framework that facilitates the planning for
any project team. The planning should come down from the highest level of the organization to the lowest level and across
functions; otherwise, each new clinical trial is like doing the first study again.
Tools of the trade
There are several tools available that can be used for the planning of a clinical trial, but those are useless if the organization
cannot capture and structure the knowledge and expertise of its people in a way that can be utilized by the entire organization.
Project planning tools available on the market allow the project manager to have under control all tasks to be performed throughout
the clinical trial, including the duration of each activity, the resources needed, and the milestones.
Apart from the technologies that are used by the project team, the main obstacle the project team faces is defining the critical
path for a global clinical trial. This includes all the tasks that need to be carried out in parallel and sequentially, when
those tasks should be completed in order to achieve clinical trial milestones, and how those activities should be performed
to successfully complete them. In order to determine the critical path for a study, it is important to understand what the
end goal is as well as to use the strategic thinking of the experienced people in the organization. As a result, the best
possible strategy will be structured in a way that can be utilized by any project team that needs to conduct a trial.
