Abstract
IntroductionMore than one‐thousand trials with functional magnetic resonance imaging (fMRI) as an outcome measure were registered in clinicaltrials.gov at the time of writing this article. However, 93% of these registered trials are still not completed with published results and there is no picture available about methodological dimensions of these ongoing trials with fMRI as an outcome measure.MethodsWe collected trials that use fMRI as an outcome measure in the ClinicalTrials.gov registry on 13 October 2018 and reviewed each trial's record entry. Eligible trials’ characteristics were extracted and summarized.ResultsIn total, 1,386 clinical trials were identified that reported fMRI in their outcome measures with fMRI as the only primary outcome in 33% of them. 82% of fMRI trials were started after 2011. The most frequent intervention was drug (pharmacological intervention) (29%). 57% of trials had parallel assignment design and 20% were designed for cross‐over assignment. For task‐based fMRI, cognitive systems (46%) based on Research Domain Criteria (RDoC) was the most frequent domain of tasks. Less than one‐third of trials (28%) registered at least one region of interest for their analysis. Food cue reactivity task, pain perception task, n‐back task, and monetary incentive delay task were recruited in more than 25 registered trials.ConclusionThe number of fMRI trials (fMRI as an outcome measure) with both task and rest protocols is growing rapidly. Our study suggests a growing need for harmonization and standardized checklists on both methods and analysis for preregistration of fMRI‐based outcomes in clinical trials.
Highlights
FMRI is the most powerful and dominant imaging technique in living human brain that have entered a variety of branches of today’s clinical research to apply new advances in clinical practice
In this study we examined Functional magnetic resonance imaging (fMRI) as an outcome measure, but speaking more broadly, by NIH definition of intervention—manipulation of the subject or subject's environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints—it seems that fMRI can be considered as an intervention in clinical trials in certain conditions (NIH, 2018, case #18e)
In order to develop an understanding of fMRI usage in clinical trials as an outcome measure, we systematically reviewed the fundamental characteristics of eligible trials registered in the ClinicalTrials.gov before 2019
Summary
FMRI is the most powerful and dominant imaging technique in living human brain that have entered a variety of branches of today’s clinical research to apply new advances in clinical practice. Changes in specific brain activity after taking pharmacological agents are detected by fMRI to evaluate the effect of treatment in early phases in drug trials. In this regard, fMRI would be promising for accelerating the development of new treatment; In drug development for mental health disorders, urgent need for new treatment was address by an NIMH program, Fast-Fail trials (FAST), utilizing target-engagement biomarkers including fMRI as one of the potential functional biomarker (https://www.nimh.nih.gov/researchpriorities/research-initiatives/fast-fast-fail-trials.shtml). If following that checklist becomes obligatory by policy makers and granting agencies as a module in the protocol registration in formal clinical trial registries, like clinicaltrials.gov, hopefully it will result in more valid and replicable fMRI outcomes in clinical trials in long term. As a potential pre-registration role that clinicaltrials.gov could play in future for an fMRI specific data element, we explored the extent of available pre-registered data in clinicaltrials.gov and provided few recommendations
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