REVEAL: Planning clinical studies on a sound basis

Before planning a new clinical trial, it is important to clarify what is already known. This is precisely where the “REVEAL” guideline, now published in the British Medical Journal (BMJ), comes in. Under the title „Identifying prior evidence for new trials (REVEAL): guidance for clinical researchers“, international researchers present a practical approach to searching for existing evidence more efficiently and transparently before deciding on a planned study.

The REVEAL guidelines were developed with significant input from the Department for Evidence-based Medicine and Evaluation at the University for Continuing Education Krems in cooperation with the University of Basel. The project, funded by the Swiss National Science Foundation (SNSF), was led by clinical epidemiologist Prof. Dr. Dr. Matthias Briel, who secured third-party funding for the international research project.

“With REVEAL, we support clinical researchers with step-by-step instructions on how to identify relevant studies in a structured and efficient manner during study planning in order to decide on the necessity and design of a new clinical study,” says Ursula Griebler, PhD MPH, REVEAL project manager at the University for Continuing Education Krems.

Specifically building on existing knowledge

Although systematic reviews are considered the basis of evidence-based research, in practice they are not always consistently integrated into study planning. REVEAL addresses this issue and presents a clearly structured, step-by-step approach that can be applied even with limited time and human resources.

The guide explains how to identify and evaluate existing systematic reviews based on their timeliness and methodological quality. If no suitable or current reviews are available, the guide provides a pragmatic approach to comprehensively documenting a search for individual studies that have already been conducted, are ongoing, or have not yet been published. This approach ensures that the planning of new studies is consistently embedded in the existing research context. REVEAL offers practical advice for determining the necessity of a new study, illustrated by ten real-life examples from the literature.

Quality and responsibility in study planning

REVEAL formulates binding criteria for evidence-based planning of clinical studies and supports researchers in placing new projects in a comprehensible context within the existing body of knowledge. The guidelines were developed in a multi-stage process that included systematic literature reviews, consultations with an international panel of experts, and formal usability tests.

With its publication in the BMJ, this approach is gaining international visibility, thereby strengthening the integration of evidence-based principles in clinical research. "Using REVEAL when planning a new clinical trial can help fulfill a key element of an evidence-based research approach and provide guidance for researchers, funders, and ethics commissions," says Griebler.