While there is an exponential amount of information that can be included within a clinical
research protocol, below are 6 high level components that should be considered prior to finalizing and implementing a protocol for your clinical trial:
- General Information: Simple yet effective, a protocol should include the title, a protocol identifying number (if any), and a version date. A name and address of the sponsor or who is funding the clinical trial should also be included, along with a name and address of the clinical laboratory and any other medical and/or technical department(s) and/or institutions involved in the research, if applicable. A brief synopsis can also be included, providing the overall schematic and schedule of activities the clinical trial intends to follow.
- Introduction: A detailed description of the therapeutic area should be mentioned within the introduction, including information about how the trial that is being conducted can help treat or prevent issues related to that therapeutic area. In addition, a thorough description of the investigational product, the investigational product’s regulatory status and any preclinical or clinical studies that have been conducted to allow you to present findings that have a potential clinical significance; are all ideal items to include in a clinical research protocol. Furthermore, a summary of the known and potential risks and benefits, if any, to human subjects can be included within the introduction of the protocol.
- Study Objectives and Endpoints: This section should answer the following questions: “Why is the research being conducted?” and “What is the rationale or relevance of this research?”. The objectives and endpoints should provide the clinical study staff with the most important rationale of why the data is being collected.
- Study Design: The overall design of the clinical trial will certainly be altered depending on what type of trial is being conducted, however should include topics such as inclusion and exclusion criteria, the number of clinical sites to be included, the number of subjects required to have a successful trial, expected duration of the study and what type of study is being conducted (such as single-blinded or double-blinded, prospective or retrospective, multi-center or single-center, etc.).
- Study Procedure: Arguably the most important section of a protocol, this component should include detailed information on the procedures to be followed, measurements to be taken, observations to be made, laboratory tests to be done, etc., from the time a clinical site is initiated to the conclusion of all research activities. Think of this section of a protocol as being a step-by-step manual of how the study staff need to conduct the clinical trial according to the overall vision. The more detail may be better, taking steps to avoid gaps, unclear information, and ways for study staff to divert from the intended plan. Keep in mind to use affirmative language such as “must” and “will” and avoid “should” or “could” in which directive is not very clear and may leave room for debate. In addition, consider adding a timetable or flowchart, thereby ensuring completeness and accuracy can be obtained. Good Clinical Practice places special emphasis on protecting the health and safety of the participants. Therefore, consider adding details of how an assessment of safety will be performed with individual events and trends, and noting that steps will be taken for a change in the protocol and that termination of the clinical trial may be warranted.
- Data Management and Statistical Analysis: A protocol should provide information on how the data will be managed, typically following advice from a statistician. The statistical methods proposed to be used for the analysis of data should be clearly outlined, including reasons for the sample size selected, power of the study, level of significance to the research hypothesis, etc.
Writing a clinical research protocol can be the most difficult stage of conducting a clinical trial; however, ensuring the document adequately answers the research question and provides enough detail to assist the study staff in obtaining the data required, will lead you on the path of having an effective and successful clinical trial.
Were you involved in the construction of a clinical research protocol? What components did you utilize and what other factors would you consider for your next protocol? If you find yourself falling just shy of creating a comprehensive and significant protocol, contact us; we can help.#3 via photopin (license)