Project Management In Clinical Trials

 INTRODUCTION

Project management is defined as a system that ensures the delivery of quality (minimized risks and clean data) with efficiency and punctuality. The processes involved in running a clinical investigation must conform to the defined qualities and standards of the project's protocols and adhere to the specified schedules. Effective project management in clinical trials involves the application of processes, actions, knowledge, skills, and content to achieve project objectives. Well-developed project management plans and monitoring processes are beneficial for successful clinical trials. This module provides guidance for managing funded clinical trials from planning through action and closeout.

PROJECT PLANNING

A clinical trial shares many features with other types of business projects within the field of project management. These features include:

Clear objective aimed at bringing about change

Require a team

Set time scale

Defined resources to achieve the objective

Tasks to be completed to a predefined standard

All projects consist of a series of processes and actions that bring about results. The five basic process stages are:

Initiating phase: Defines the project's vision, initial scope, limitations, and identifies stakeholders.

Planning phase: Establishes the total scope of the project, including schedules, risks, goals, stakeholder management, and funding.

Execution phase: Involves acquisition, development, and management of teams. Quality assurance, communication, and engagement among researchers and stakeholders occur in this phase, and goals are achieved.

Monitoring & Controlling phase: Involves making significant decisions such as termination, adjustment, or continuation of the project. It also includes adjustments in work, scope, schedule, cost, and risk.

Closing phase: Marks the formal process of project closure.

PROJECT MANAGEMENT PROCESS

The trial execution process can be divided into three phases for effective management:

Pre-Trial phase: Characterized by setup activities.

Trial Execution phase: Involves major trial activities such as enrollment, measurement, etc., heavily relying on the study.

Monitoring and Evaluation: A study closeout phase that includes activities like initiation of final regulatory reports, issue resolution, and archiving. Proper planning during the pre-trial phase ensures a return on investment during trial execution and closeout.

COMMUNICATION

Effective communication is crucial in clinical trials. Investigators should feel quantitatively and emotionally part of an inclusive team answering an important clinical question. Providing daily feedback and ensuring personalized communication through preferred methods (telephone, email, letter, website, personal contact) helps investigators feel involved and maintains their commitment. Positive communication about trial progress and addressing problems promptly increases confidence in the trial and the trial team.

EFFICIENT SYSTEMS

Well-developed systems and procedures are essential for the day-to-day running of a trial, especially for larger trials. A systematic approach should be established to monitor recruitment, randomization procedures, stock control, data management, data cleaning, and central data monitoring. Documentation should be concise, following standard operating procedures, and every trial-related paper should be tracked systematically. Consideration should be given to the international nature of the trial, taking into account differing clinical practices, working environments, and governance regulations.

MANAGEMENT OF PROJECT PERSONNEL AND RESPONSIBILITIES

The management team should create a listing of personnel based on their roles and responsibilities. Clearly identify individuals responsible for executing the work and those ultimately accountable for completion. Additionally, identify individuals with alternate responsibilities for consulting or approving specific tasks and functions.

CONCLUSION

Effective management is crucial in clinical research to carry out all necessary tasks and achieve study objectives. Standardizing trial management methods, providing training, and incorporating trial management practices into research publications can contribute to improved trial management and better healthcare outcomes.

REFERENCES

Harvard IFAR Connect: Project Management - https://ifar-connect.hsl.harvard.edu/isac_book/project-management.html

Trials Journal: Project management in clinical trials - https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-11-78

NCBI: Project Management of Clinical Trials - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4586955/#A11602R9

Student Name: Bollu Divya Durga

Student ID: 045/0323

Qualification: M.Pharmacy

e-Mail ID: bolludivyadurga@gmail.com