“Management is, above all, a practice where art, science, and craft meet.” Henry Mitzberg claims that management is the convergence of different skills, knowledge, and discipline. These elements are being utilized to carry out whatever it is that an individual or group is managing. These key attributes can clearly define the outcome of whatever it is that is being managed. Whether they are people, processes, or products, management brings order, goals, and vision to the project being fulfilled.
Is Clinical Research a Project
The Project Management Body of Knowledge, or also known as the PMBOK Guide, explained that a project is anything that can be categorized as “a temporary endeavor undertaken to create a unique product, service, or result.” Using this definition, it could be inferred that a Clinical Trial can also be considered as a “project” for several reasons. First, Clinical Trials are temporary studies because they have clear definitions of its starting and end points. Second, Clinical Trials aim to formulate, study, or experiment new devices, diseases, or drugs. Therefore, it can be concluded that, using the definition by the PMBOK, Clinical Trials are also projects.
Project Management in Clinical Trials
As reported by Goodarzynejad and Babamahmoodi in the their published article “Project Management of Randomized Clinical Trials: A Narrative Review” (2015), they stated that, “Clinical Trial Management is most simply defined as that an organization follows to ensure that quality (defined as minimized risks and clean data) is delivered efficiently and punctually.” Processes that are involved in running a Clinical Research are being executed in accordance to the qualities and standards that every protocol defined in the project and also to the schedules that need to be adhered to.
Furthermore, according to Madhuri Patel in his published paper “Effective Clinical Project Management to Streamline Clinical Trial” (2018), he stated that, Clinical Research are instances of projects which take systematic efforts to answer scientific and health related questions or problems.” It is very obvious and common to a Clinical Trial to have countless processes and data being monitored, enforced, and evaluated all at once. So, clearly, Project Management disciplines should be implemented in order to maintain the orderliness, accuracy, and quality of the study results. After all, careful and critical handling of data must be ensured because the scientific approach is the most ideal approach since Clinical Trials are dealing with various components such as study approaches, recruitment processes, laboratory investigations, product examinations, data gathering and analysis, materials and site management.
5 Steps of Project Management
According to Hope Cullen in her book “Effective Project Management for Clinical Trials”, a Clinical Trial can be broken down into 5 Stages: Initiating, Planning, Execution, Monitoring & Controlling, and Closing.
Initiating phase is where the project’s vision, initial project scope and limitation, and stakeholders identification are being defined.
Planning phase is where the total scope of the project is being established, schedules, risks, goals, stakeholder management, and funds are being built.
Execution phase is where the acquisition, development, and management of teams are being done. This is where quality assurance, communication, and engagement among the researchers and stakeholders take place. This is also where the goals are being achieved.
Monitoring & Controlling phase is where big decisions are being made: to terminate, adjust, or continue. This is also where the adjustments in work, scope, schedule, cost, and risk are being done.
Closing phase is where the project ends using a formal process.
Tools for Success in Managing Clinical Trials
According to Farell, Kenyon, and Shakur, in the published paper “Managing Clinical Trials” (2010), they state that, “Many clinical trials fail to deliver because of the lack of a structured, practical, businesslike approach to trial management. The human and financial resources for conducting a randomized trial is finite, so it is crucial that every effort is made to ensure that a trial is implemented simply and managed efficiently.” The fate of a study, whether it becomes a success or a failure, is dependent on how the trial is being managed. A Clinical Trial is composed of countless data, various people and processes working simultaneously. So, it is just fair to say that competent, reliable, and skilled people are required to work in the medical field.
Clinical Trials have grown in complexities and competition over the years. According to Patel (2018), the role of a Clinical Project Manager is to balance scientific integrity and business interest. Furthermore, he claimed that a Clinical Project Manager should possess these key qualities: Knowledgeable, Organized, Trusting, Approachable, & Transparent.
The Project Manager is the link between the investors, PI (Principal Investigators, and the researchers to be able to communicate the plans that are agreed upon. The importance of Project Managers are being recognized by industry and regulatory bodies. To be exact, Project Management Institute plans to be governed by the ISO or International Standards Organization to have PMs certified.
As former US President Benjamin Franklin said, “By failing to prepare, you are preparing to fail.” A goal without a plan is just an idea. Clinical Trials are big, multimillion projects that involve countless processes and regulations. To be able to achieve its ultimate goals, it must achieve careful planning first.
According to Patel (2018), “Clinical trials have the same features as other business projects as defined in the field of project management.” The features of business projects may include the following: Definition of Objectives, Team Recruitment, Timelines and Timeframes, Resources and Funding, Designation of Tasks.
The Plan of the Clinical Trial should clearly state what the researchers are achieving, how the funds would be utilized within a given amount of time. The plan should also distinguish how each process will be monitored to ensure that all of the elements are in accordance and adherence to what the project is trying to achieve and be delivered as organized.
Management is truly the convergence of different skills, knowledge, and discipline; put together to guide an endeavor to its success or failure. In Clinical Research, proper management is imperative to be able to carry out all of the necessary tasks in order to achieve what the study is trying to achieve. After all, tools in a toolbox won’t fix anything unless a carpenter or a mechanic uses them.