1) Disease diagnosis as part of inclusion/exclusion criteria
2) Safety assessment
3) Clinical efficacy endpoint
There are many medical imaging technologies. Here are just a list of some:
1) x-ray
2) CT scan
3) MRI
4) PET scan
5) Ultrasound
6) arteriogram or angiography
7) venogram
There is benefit and risk in using the medical imaging in clinical trials. Some imaging can pose extra safety issues. For example, x-ray, CT scan, PET scan can put the study subjects at extra radiological exposure. Arteriogram and CT/A can expose the subjects to additional contrast medium or dyes which may have its own safety issue.
Medical imaging is always a surrogate endpoint. The technician plays the important role in obtaining the imaging. The standardization and calibration are always important in order to obtain the reliable data especially in longitudinal studies. The interpretation of the imaging results depend on who read the imaging. There could be substantial variation between different readers. Therefore, the central reading is very important if the medical imaging is used in clinical trial. There are quite some articles discussing the imaging in clinical trials in the Applied Clinical Trial magazine.
There are several specialty medical imaging vendors on the market. Some of them are listed below:
1) BioClinica or Bio-imaging
2) Biomedical Systems
3) Perceptive (part of Parexel)
4) Synarc
FDA and EMEA has issued several guidance on imaging used in clinical trial. For example:
This guidance discussed the clinical trials with imaging endpoints - i.e., the reading from medical imaging is used as the efficacy endpoint. Examples are: RECIST criteria for assessing the tumor size for solid tumor based on FDG-PET or MRI. Lung density measure by CT scan to assess emphysema.
2) FDA guidance Developing Imaging Drug and Biological Products,
- Part 1: Conducting Clinical Safety Assessments) (Imaging Drug Guidance Part 1) ;
- Part 2: Clinical Indications (Imaging Drug Guidance Part 2);
- Part 3: Design, Analysis and Interpretation of Clinical Studies (Imaging Drug Guidance Part 3)
3) FDA guidance on "New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products"
4) Developing Medical Imaging Drugs and Biologics
5) EMEA Concept Paper on "The Harmonisation and Update of the Clinical Aspects in the Authorised Conditions of Use for Radiopharmaceuticals and Other Diagnostic Medical Products"
Additional reading:
4) Developing Medical Imaging Drugs and Biologics
5) EMEA Concept Paper on "The Harmonisation and Update of the Clinical Aspects in the Authorised Conditions of Use for Radiopharmaceuticals and Other Diagnostic Medical Products"
Additional reading:
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