Clinical Research Data Management 101
Over the past decades, scientists have written influentially and continuously of the need for large, controlled trials. These trials are considered the apex level of proof for directing clinical practice. Moreover, these commentaries do not contain any mention on managing these trials. Clinical trials sometimes fail to deliver as they lack structure, business-like approach, and practical application. A randomized trial involves a huge amount of investment with respect to time, money and humans; and hence it should be managed from its inception to its conclusion like any other business. Trial management is necessary among the key skills required to deliver high-quality results. A well-designed trial is the basis for resolving clinical questions and science alone cannot make it a successful one. Clinical trials require a coordinated process, irrespective of their size, cost, scope or duration.
What makes a successful trial?
Farrell and Kenyon suggested that actively managing all aspect of a trial makes it successful. The participants involved should be made comfortable with the trial and should be trained for the process. There are various methods of training including one-to-one training, distance learning methods, etc. Every project consists of a sequence, a set of actions to bring about results. The five stages that reflect the life cycle of a trial are:
Monitoring and controlling
Analysis and reporting
Therefore, development of a management plan is an essential factor for effective trial management. The steering committee should decide how the day to day activities of the trial will be planned and managed.
All research projects should appoint a trial manager. The trial manager should be involved in the project early in the trial design phase. This would save a lot of resources in terms of money and human labor. The primary responsibilities and attributes of a trial manager are:
Taking a lead role in planning, coordinating and completing a project
Excellent communication and presentation skills
The ability to motivate others
Ability to manage the trial budget(s) and maintain accounts
Planning the trial is one of the trial manager’s main responsibilities, but the whole team should be involved in the process for the plan to be successful. This involves:
Setting a clear objective
Deploying appropriate manpower
Putting time constraints
Tasks which need to be completed (to a pre-specified standard)
Without clear communication between team members, many problems may arise. For example, if a researcher doesn’t communicate to the other team members that a certain trail phase has finished, or a patient has left the trial, time consuming and costly mistakes can be made. Furthermore, investigators need to feel valued and should be made a part of the team answering clinical questions. This gives the team a sense of motivation and keeps them informed about the trial.
Efficient recruitment of trial participants
The success of a trial depends on the factor that it manages to recruit the specified participants to reliably answer questions.