For all clinical trial at ARIRDMSCRO, we mandate the requirement of the development of a work plan (or scope-of-work document) that can be used to clearly define which department is responsible for which task when the study is being conducted by multiple departments out of a single institution. Likewise, the same document can be drawn upon to define responsibilities if multiple institutions (e.g., a coordinating center and a statistical center) are involved. The more the detail included in this document in advance, the more likely it is that the important tasks will not be missed and that each group is not assuming that someone else is responsible for the task. A scope-of-work document can also be utilized to help with budgeting for the different members of the team.

Another critical document to create as part of the initial planning requirements is a timeline with realistic milestones. There are many tools that can be exploited to create a timeline, including Microsoft Project software. Appropriate Gantt charts and resource planning are part of Microsoft Project, need to know how to input the needed data to make it a useful tool. The timeline, in conjunction with the scope-of-work document, will collectively provide the roadmap for the overall project. The project management plan is a living document throughout a clinical protocol and needs to be constantly updated to mitigate all risks arising in a study conduct as well as serve as a working doctrine helping in smooth conduct of a clinical protocol.

A more accurate control, regardless of the therapeutic area or trial stages (all the way through from phase 1 to ‘post-approval’ phase 4 studies), is ensured by typically breaking down the life cycle of each clinical trial project into 4 phases: conceptual, planning, implementation, and analysis. A project is based on input, which is normally supplied by the sponsor of the project and generates the output. An input is the objective to be achieved in a specific predetermined time (enrolment/randomization of X evaluable subjects in X months, the sponsor inclusion in the database of data collected in X days, etc.) and is generally described in the contractwhich can be Master Services Agreement (MSA) or Transfer of regulatory obligations (TORO) or Letter of Intent (LOI). A clinical study produces an output that will ultimately help provide answers to the study objectives; these results are described in a clinical study report that states formally the end of the study. As we move through the implementation phase, the amount of work and number of players involved increase significantly and this is where project management becomes more critical. Monitoring is an essential element for project management and is constantly done throughout the duration of the project. It allows managers to collect measures and disseminate performance information in order to identify areas that need special attention and to implement any improvement in form of actionable or trainings. A phase of a project usually ends with a review of the tasks and monitoring of the objectives.

At ARIRDMSCRO, our clinical project manager is the person responsible for managing the project in order to achieve the objectives in respect of cost and time as well as the technical quality of the result. While trial managers are not required to complete all the tasks, they are responsible for ensuring that all aspects of the project are planned, implemented, monitored, and controlled on a daily basis, and project outputs and outcomes are obtained in trial management plans.

A perfect project plan will ensure’s the success of a project, without its implementation the success is not ensured, and credebiality of data produced cannot be confirmed by clinical trial manager. The requirements of a clinical project manager are similar to those of any other project manager (communication and presentation skills, ability to organize and motivate others, enthusiasm, drive innovation and leadership, ability to manage the budget of the study and monitor costs, strategic and operational skills to plan and conduct a study, capacity to mediate between the various figures), but also add to these scientific competence and motivation. The manager can detect and correct errors that are sometimes severe (e.g., protocol deviations, deviations in consent), emphasizing the importance of monitoring throughout the conduct of the study. Regular and constant complete communication between the trial manager with the clients (sponsor) and/or principal investigator and other stakeholders is essential to make sure all aspects, remain on track as per the original plan. Clinical trials at all times need the same coordinated processes and systems, irrespective of the size, scope, costs, or period. The key challenge is to implement and maintain effective management systems and techniques in response to the needs of the trial project. Drug/Devices and biologics development projects have to contend with several factors, including inability to control patient registration, unpredictability of clinical outcomes (e.g., adverse events), and reliance on regulatory agencies (e.g., the CDSCO), for the approval of a new drug, which influences schedule, and budget as the key performance indicators of project management. As a result, even with the application of project management, the best we can do is to improve our predictions, for the possible launch dates of new products into market.

Another apparent challenge in clinical trials is to register the patient sample size as timely and efficiently as possible. Each clinical trial is unique because one tiny difference in the protocol needs between two trials may lead to drastic changes in yielding recruitment lifecycle and register timing parameters. Many factors such as inclusion/exclusion criteria, visit schedule, recruitment tactics, placebo allotment, development phase, and patient motivation can potentially affect the final number of patients who enroll in the trial. A lower number of available patients than is expected usually results in an extended length of time to recruit a certain number of patients and increased costs. Multicenter trials provide high-yielding recruitment strategies that can be advantageous if a large number of patients is required and also offer the advantage of higher generalizability per our experience.

Identifying appropriate clinical sites and setting up realistic enrollment expectations are our strategies in multicenter studies. As in many a case we have seen, that investigator site principal investigators often lack the time to spend on administrative tasks, it is crucial to have a dedicated clinical trial team with trial coordinator who could adopt much of the time.

Project management in health and medical research may substantially benefit both the managerial and scientific aspects of medical drug/devices projects.