What is a ‘trial injury’: a metaphor not a literal concept!

In our experience, too much research is rushed through the planning phase to reach a result as fast as possible, leaving no time to consider the handling of pitfalls, caveats and obstacles on the way. Such unpreparedness of research management may lead to useless and untrustworthy research methods in clinical trials that seek to answer otherwise excellent and relevant research questions. If we use a SEM metaphor, methods failures can be considered ‘trial injuries’ and they are often ‘treated’ during the remainder of the trial or via tweaked analysis methods. Many investigators ‘treat’ the injury in the hope that the ‘paper’ survives (first priority) and that a useful answer to the research question is achieved (second priority). The ‘treatment’ is in most cases unsuccessful and the order of priorities is flawed–the integrity of the research question should be prized above all else. When a trial sustains such a preventable injury, the usefulness and trustworthiness of the results are degraded and it may be appropriate to disregard that trial from the body of literature.

An example of a preventable and untreatable ‘trial injury’ is failure to register a clinical trial and/or provide clear documentation of the a priori research question, hypothesis and primary outcome before inclusion of the first participant. This is much like the anterior cruciate ligament injury; a point of no return injury that can never heal, but only reconstructed. Just like the ACL reconstruction, this type of post hoc procedure will never be able to compensate fully for the sustained damage and may have unfavourable long-term consequences.

Unfortunately, there are no effective treatments for ‘trial injury’; thus, good ‘prevention’ strategies are essential. The PREPARE trial guide published in BJSM is an attempt to offer such a trial injury prevention strategy.4 It offers a comprehensive resource and guidance that will hopefully help its readers and users to move the SEM field forward by focusing on how we can all prevent poor clinical trial research rather than treat the research methods disasters that arise.

Prepare by using PREPARE guidelines

The guide does not replace other guidance or checklists but serves as a more practical ‘How to’ guide and directory with references to the most recent credible sources of information about effective trial-research conduct. It is for those who want to keep abreast of developments and recommendations within research integrity, trial transparency and efforts to reduce research waste; it is for those who want to make informed choices in the planning of their trial research. The guide can be read as a whole, but is meant as a reference that can be consulted at different phases of trial planning. The guide offers an overview of the growing literature and recommendations in the field of trial research methodology, and includes references to central sources of further in-depth reading. By focusing on the planning of a clinical trial, what we have referred to as ‘trial injury’ is less likely to occur, and the produced information is more trustworthy and clinically useful.

We hope that the PREPARE trial guide will assist and supplement the existing body of research guidance and checklists, and provide a useful and trustworthy contribution to the prevention of trial injury within SEM research. It covers many practical aspects of clinical trial planning that the established checklists will not tell you. It includes information that we have personally missed during our own clinical research journey, and it aims to eliminate the frustrations that we often hear from students at a stage when it is too late to restore the damage done. As in SEM, prevention is better than treatment and for some conditions it is the only effective intervention.