Clinical trial project management is a complex and multifaceted process that involves the coordination of various activities and stakeholders to ensure the successful planning, execution, and completion of clinical trials. Effective project management is essential to ensure that clinical trials are conducted efficiently, safely, and within budget. The 5 stages of project management can be applied to clinical trials and be formed into an effective clinical project lifecycle.
The practices associated with project management of clinical trials is crucial to the success of that trial. As the primary point of contact between the sponsor, study team, and regulatory authorities, the project manager is responsible for ensuring that the study is conducted in compliance with all relevant guidelines and regulations. They are also responsible for managing the study timeline, budget, quality, and for overseeing study teams to ensure that objectives are met. The project manager plays a key role in ensuring that the study is conducted efficiently and effectively, and in securing that the study data is accurate and reliable. This article will explore the key aspects of clinical trial project management, placing the clinical trial lifecycle into the principles of the Project Management Institute (PMI), while suggesting some potential best practices for each project stage.
Regardless of project type, per the PMI, projects can be seen to have five key stages in its lifecycle: initiation, planning, execution, monitoring, and closeout. The PMI’s approach is seen as effective regardless of the industry due to its overarching end-to-end framework. This approach is particularly well-suited to clinical trials, where there are many complex regulatory and logistical considerations, and where project success relies heavily on effective planning, communication, and risk management. By following the PMI's 5-stage approach, clinical trial project managers can ensure that their projects are executed efficiently, effectively, and in compliance with all relevant guidelines and regulations. A potential project lifecycle, when following the PMI’s framework is shown in Figure 1.
The project initiation phase is the first stage of clinical trial project management, where the study is conceptualized, and initial planning is undertaken. It involves defining the study objectives, developing a study protocol, identifying potential study sites and investigators, and obtaining the necessary regulatory approvals. Below are some of the key aspects of the project initiation stage that a clinical project manager should pay attention to:
1. Study feasibility assessment: Prior to the initiation of a clinical trial, the feasibility of the study should be assessed to determine if it is viable to conduct the study within the proposed timeline and budget. This assessment should take into consideration the study design, patient population, availability of suitable study sites, and regulatory requirements.
2. Study protocol development: The study protocol is a detailed document that outlines the study design, study objectives, inclusion and exclusion criteria, study procedures, data collection and analysis methods, and other relevant information. The protocol should be developed in accordance with regulatory requirements and GCP guidelines.
3. Study site and investigator selection: The selection of study sites and investigators is a critical aspect of clinical trial project management. Potential study sites and investigators should be identified based on their experience, qualifications, and availability, and should be thoroughly evaluated to ensure that they meet the study requirements. In addition, the entire study team should be defined with clear roles and responsibilities for all team members, utilising tools such as a RACI.
4. Regulatory approvals: Clinical trials must obtain regulatory approval from the relevant regulatory authorities before they can begin. The process of obtaining regulatory approvals can be lengthy and complex, and project managers must ensure that all necessary approvals are obtained in a timely manner, prior to the next stage of the project lifecycle.
5. Study budget and timeline development: The development a study budget and timeline are important aspects of clinical trial project management. The budget should take into consideration all study costs, including personnel, equipment, and other expenses, and should be developed in accordance with the study protocol. The timeline should be developed based on the study objectives, site selection, regulatory requirements, and other factors.
By effectively managing the project initiation stage, project managers can ensure that the clinical trial is well-designed, feasible, and compliant with regulatory requirements, which sets the foundation for the successful execution of the trial.
Proficient project planning is an essential component of successful clinical trial conduct. Project planning should involve the development of a comprehensive project plan that outlines the project scope, objectives, sequence, timelines, budget, resources, and risks. Additionally, that project plan should be reviewed and approved by all stakeholders to ensure that there is a shared understanding of the project goals and expectations. Below are some key aspects of the project planning stage of clinical trial project management:
1. Detailed project plan: The project plan should outline all study procedures, timelines, budgets, and resources required to complete the study. The plan should consider the risks and bring together all the key study tasks into a detailed timeline for the study duration.
2. Resource allocation: The resources required by a clinical trial should be considered to ensure sufficient resources are available to complete the study within the proposed timeline and budget. This includes allocating personnel, equipment, and other resources required for the study. Resource allocation should take into consideration the study protocol, site, operational, and regulatory requirements.
3. Risk management: Project managers must identify, assess, and manage risks associated with a clinical trial in accordance with regulations and guidelines. The International Council for Harmonisation (ICH) guideline E6 (R2) provides guidance on risk-based approaches to clinical trial design, conduct, and reporting Project managers must ensure that all risks are identified and evaluated, and that appropriate risk mitigation measures are put in place to minimize or eliminate potential harm to study participants, as well as risks to data quality and trial integrity3. This includes developing contingency plans, establishing protocols for dealing with adverse events, and ensuring that study personnel are trained on risk management procedures. Risk management requires effective communication and collaboration among stakeholders, including sponsors, investigators, and regulatory authorities.
The project execution phase of clinical trial project management involves the implementation of the project plan, the collection of study data, and the monitoring of study progress. Below are some key project management practices in the project execution phase:
1. Stakeholder management: Effective stakeholder management is essential to ensure that clinical trial projects are conducted successfully. The literature suggests that stakeholder management should involve the identification and engagement of all stakeholders, including partners, regulatory authorities, investigators, trial participants, and trial staff. Effective stakeholder management involves developing communication strategies, managing expectations, and addressing any concerns stakeholders may have. The project team should then develop a stakeholder engagement plan that outlines the communication strategy, roles, and responsibilities of each stakeholder, and the frequency and mode of communication. Regular meetings should be held with stakeholders to keep them informed of project progress, address any concerns they may have, and obtain feedback.
2. Patient recruitment and retention: Project management must develop strategies for patient recruitment and retention. This includes developing recruitment materials, identifying eligible patients, and implementing retention strategies to keep patients engaged in the study.
3. Change and performance management: Trial changes are common and need close management to ensure they are planned and implemented in a timely and regulatory compliant manner. This includes identifying potential impacts of changes, obtaining necessary approvals, and communicating changes to study personnel and stakeholders. Metrics such as key performance indicators (KPIs) can be utilised as a tool to quantify performance standards.
Project monitoring and control are critical aspects of clinical trial project management, as they involve tracking and managing project progress, performance, and outcomes. The literature suggests that project monitoring and control should involve the regular collection and analysis of project data, including project timelines, budget, and quality metrics. To effectively monitor a clinical trial, project managers should consider the following practices:
1. Data management: Project management is responsible for ensuring that study data is accurate and reliable, utilising necessary technology to streamline study processes and improve efficiency and accuracy. Data management should be overseen by the clinical project management, below are some tools utilised to ensure good oversight:
a. Data management plan: Develop a data management plan that outlines how study data will be collected, stored, and analysed.
b. Data standards: Ensure that data is collected and managed according to industry standards, such as CDISC or SDTM.
c. Data quality control: Implement data quality control procedures to ensure that data is accurate and reliable.
d. Technology integration: Integrate technology solutions, such as electronic data capture (EDC), interactive response technology (IRT) or clinical trial management systems (CTMS), to streamline study processes, utilise automation and improve efficiency.
e. Data security plans: Ensures that study data security is considered, and that access is restricted to authorized personnel only.
2. Site monitoring: Regular site visits must occur in clinical trials, these ensuring that study procedures are being followed. The regular review of site’s processes ensures that good clinical practice is followed, and a good quality of data is being maintained. These visits can be a good way for the study team to keep the communication and site engagement positive; this should be closely overseen by project management.
3. Quality control: All trial procedures must be conducted in accordance with the study protocol, regulatory requirements, and good clinical practice. This includes reviewing data quality, conducting site visits, and ensuring that study personnel are trained on study procedures. It is the responsibility of clinical project management to ensure these practices are followed on the trial.
4. Adverse event reporting: Adverse events must be closely tracked, and when needed are reported according to regulatory requirements. This includes promptly reporting adverse events to the sponsor and the relevant regulatory authorities.
Trial closeout is the final stage of clinical trial project management. This stage encompasses the activities of finalizing study data, completing study documentation, and communicating the study completion with regulatory agencies. Project managers should consider the following practices when planning for trial closeout:
1. Archiving study documentation: All study documentation must be properly archived and retained in accordance with regulatory requirements. Clinical project management must oversee this process and ensure that study records, case report forms and other key documentation are archived in a timely manner.
2. Finalise monitoring: Clinical project management must conduct a final review of study data and documentation to ensure that all study procedures were conducted in accordance with the study protocol and good clinical practice. This entails verifying that all data has been entered and verified, conducting a final site visit, and ensuring that all study personnel have completed their responsibilities.
3. Clinical study report: A clinical study report is prepared for clinical trials which summarizes the study results and provides an overview of study conduct. This report should include information on study recruitment, data quality, adverse events, and other study metrics. Project management should closely manage the timeline associated with this, ensuring stakeholders such as medical writers are regularly communicated with.
4. Dissemination of study results: Project management must ensure that study results are disseminated in accordance with regulatory requirements and best practices. The results of a study may be published in peer-reviewed journals, presented at scientific conferences, or provided in-full or in-summary to study participants and other stakeholders.
Conclusion:
Literature suggests that effective clinical trial project management involves the development of a comprehensive project plan, ongoing risk management, effective stakeholder engagement, high-performing team management, and regular project monitoring and control. Through utilising the PMI’s 5-stage approach, an effective lifecycle can be formed for project managing clinical trials. By considering these practices in the planning of their own studies, clinical trial project managers can ensure good oversight of their clinical trials, which leads to safe and efficient studies.
References:
1. Somma, G. (2008). Project management from the middle. Paper presented at PMI® Global Congress 2008 —North America, Denver, CO. Newtown Square, PA: Project Management Institute
2. Food & Drug Administration (2018). E6 (R2) Good Clinical Practice: Integrated Addendum to ICH E6 (R1). Silver Spring, MD: Food & Drug Administration. 1-69.
3. Cullen, H. Effective Project Management for Clinical Trials. eBook: Imperial Clinical Research Services. 1-22.
4. The Interventional Studies in Aging Center at the Institute for Aging Research (2018). A Clinical Trials Toolkit. eResource: Harvard.edu.
5. Food and Drug Administration. (2013). Guidance for Industry: Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring. Silver Spring, MD: Food & Drug Administration. 1-22.
Joab Williamson is the Director, Program Management at Faron Pharmaceuticals, a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs caused by dysfunction of our immune system. He has a range of experience in pharmaceutical project management, holds an MBA and is a certified lean six sigma black belt.
