A clinical trial protocol defines the background, rationale, objectives, design, methodology, and organization of a projected clinical trial.
The two primary purposes of a protocol are to ensure that the health of the participants is protected, and formulate the research questions. The protocol also specifies what types of people may participate in the trial, a test timetable, medications and doses, procedures, and how long the study will last.
The development of a protocol is a team effort; the end result should be a document that represents a consensus among the design team members, usually a group of interdisciplinary clinical trial experts.
The protocol is an important element in the planning, preparation and implementation stages of a clinical trial. It is also the foundation of the final study report. A high-quality protocol leads to a safer, more cost-effective clinical trial.
The Challenge of Creating Quality Protocols
Creating a protocol often becomes an arduous and time-consuming process—more so than it should be.
Time is wasted in re-creating protocol data, coordinating the people involved, and sharing project information with design team members. Inefficient procedures for the management, compilation and review of the protocol document lead to delays and inaccuracies. And difficulties accessing information from clinical trial management systems and databases causes more delays. Often the resulting protocols are incomplete, and unclear.
The design process requires good communication and clearly elaborated procedures (see A Collaborative Clinical Trial Protocol Writing System for a web-based approach). Because the protocol is central to the clinical trial, improvement in protocol standards and writing procedures positively influence all aspects of the trial.