Article type
Abstract
Background: Before embarking on a new clinical trial, researchers should systematically search for and assess the existing evidence. Reviewing the literature when planning a new clinical trial not only prevents research waste but also provides a compelling justification and useful information for the design of the new trial. However, understandable and easy-to-use guidance for clinical researchers on how to systematically conduct such a literature review is lacking.
Objective: To develop guidance for clinical researchers who need to rapidly and systematically review the literature to inform the planning of a new trial.
Methods: We reviewed existing guidance and methods studies addressing rapid reviews, extracted and synthesized recommendations, consulted with a stakeholder panel, and conducted usability tests with 10 researchers with varying trial and systematic review expertise.
Results: We developed a detailed guidance document, a fillable structured report form, and a worked example suitable for a funding proposal or a trial protocol. The guide proposes a two-step review process: Part A to search for and assess existing systematic reviews on the topic of the planned trial and, if needed, Part B to search for and synthesize primary studies. After completing Part A, the reviewer decides whether Part B is necessary. If a relevant, high-quality, and up-to-date systematic review of previous trials answers the planned research question, no further review is necessary and whether or not a new trial is needed can be convincingly justified. If a new trial is needed, the available review can inform the trial protocol. If there is no relevant, high-quality, and up-to-date systematic review, the researcher should continue with Part B. A checklist with all essential tasks for Part A and Part B further supports the reviewers.
Conclusions: The REVEAL guidance and the structured report form will help clinical researchers to conduct a literature review specifically to inform the planning of a new trial. It is tailored for researchers with limited time resources and little experience in conducting systematic reviews.
Objective: To develop guidance for clinical researchers who need to rapidly and systematically review the literature to inform the planning of a new trial.
Methods: We reviewed existing guidance and methods studies addressing rapid reviews, extracted and synthesized recommendations, consulted with a stakeholder panel, and conducted usability tests with 10 researchers with varying trial and systematic review expertise.
Results: We developed a detailed guidance document, a fillable structured report form, and a worked example suitable for a funding proposal or a trial protocol. The guide proposes a two-step review process: Part A to search for and assess existing systematic reviews on the topic of the planned trial and, if needed, Part B to search for and synthesize primary studies. After completing Part A, the reviewer decides whether Part B is necessary. If a relevant, high-quality, and up-to-date systematic review of previous trials answers the planned research question, no further review is necessary and whether or not a new trial is needed can be convincingly justified. If a new trial is needed, the available review can inform the trial protocol. If there is no relevant, high-quality, and up-to-date systematic review, the researcher should continue with Part B. A checklist with all essential tasks for Part A and Part B further supports the reviewers.
Conclusions: The REVEAL guidance and the structured report form will help clinical researchers to conduct a literature review specifically to inform the planning of a new trial. It is tailored for researchers with limited time resources and little experience in conducting systematic reviews.