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Imaging in clinical trials
1Clinical Pharmacology Unit, Chapel Allerton Hospital, Leeds, UK.
Abstract:
Imaging is likely to play an increasingly important role in clinical trials of antirheumatic drugs. The need to evaluate efficacy of a drug quickly often precludes the use of radiological evaluation as an outcome measure, particularly in chronic arthritides. New imaging techniques with the refinement to detect differential early change, often between drugs of comparable potency, would be advantageous. However, the trend to set up large scale multicentre trials that have adequate statistical power for the detection of change mitigates against the use of expensive imaging techniques of restricted access. The majority of drug trials, therefore, still resort to conventional radiology. With the new generation of drugs that have specific actions, sensitivity in comparing changes in synovium, cartilage, bone and adjacent soft tissues would be of value.
Insights
Imaging plays a key role in antirheumatic drug trials. While advanced imaging offers sensitivity for early changes, conventional radiology remains prevalent due to cost and accessibility in large multicenter studies.
Area of Science:
- Rheumatology
- Medical Imaging
- Clinical Pharmacology
Background:
- Imaging is crucial for evaluating antirheumatic drug efficacy in clinical trials.
- Rapid efficacy assessment often limits the use of traditional radiological evaluation in chronic arthritis.
- There is a need for advanced imaging techniques to detect subtle, early changes, especially between drugs of similar potency.
Purpose of the Study:
- To discuss the role and limitations of imaging in antirheumatic drug trials.
- To highlight the advantages of sensitive imaging techniques for detecting early therapeutic effects.
- To consider the practical constraints of implementing advanced imaging in large-scale, multicenter drug studies.
Main Methods:
- Review of current practices in antirheumatic drug clinical trials.
- Discussion of the capabilities of conventional radiology versus newer imaging modalities.
- Analysis of the impact of trial scale and cost on imaging technique selection.
Main Results:
- Conventional radiology is still widely used in drug trials due to logistical and economic factors.
- Advanced imaging techniques offer greater sensitivity for detecting early disease modifications.
- Newer antirheumatic drugs with specific actions may benefit from imaging that assesses changes in synovium, cartilage, bone, and soft tissues.
Conclusions:
- The choice of imaging in antirheumatic drug trials balances the need for sensitivity with practical considerations like cost and accessibility.
- Future trials may benefit from incorporating more sensitive imaging to evaluate novel therapeutics.
- Developing cost-effective, accessible advanced imaging methods is important for future clinical research in rheumatology.