Medical Imaging in Clinical Trials (eBook)
XVIII, 420 Seiten
Springer London (Verlag)
978-1-84882-710-3 (ISBN)
In the last few years the use of medical imaging has increased exponentially in routine clinical practice. This has been reflected in a rapidly increasing use of medical imaging in clinical trials, through all phases. More recently this has culminated in a number of inter-disciplinary meetings with the various stake holders, including the FDA. Changes in the regulatory process has resulted, when it comes to the submission of data to the FDA, in a therapeutic agent where one or more of the trial end-points is the assessment of a radiological end-point. No longer is it sufficient to have the images read by the local investigator site.
The FDA has also identified Medical Imaging as one of the key 6 points in the Critical Path initiative which was launched in 2004. This puts a keen focus on the role of imaging and the need to clearly identify and understand this aspect of clinical trials.
As the pharmaceutical, biotech and medical device industry continues to identify ways to improve and speed up product development, medical imaging plays a more significant role. An understanding of the methodology and the metrics is therefore required but difficult to ascertain in one easy to read volume for individuals entering this field. This book will therefore fulfill this void, be it for the pharmaceutical personnel from medical director to monitor, or the Principal Investigator who is having to understand the complexities of the imaging and why it is having to be sent off-site for a 'central read.'
In the last few years the use of medical imaging has increased exponentially in routine clinical practice. This has been reflected in a rapidly increasing use of medical imaging in clinical trials, through all phases. More recently this has culminated in a number of inter-disciplinary meetings with the various stake holders, including the FDA. Changes in the regulatory process has resulted, when it comes to the submission of data to the FDA, in a therapeutic agent where one or more of the trial end-points is the assessment of a radiological end-point. No longer is it sufficient to have the images read by the local investigator site.The FDA has also identified Medical Imaging as one of the key 6 points in the Critical Path initiative which was launched in 2004. This puts a keen focus on the role of imaging and the need to clearly identify and understand this aspect of clinical trials.As the pharmaceutical, biotech and medical device industry continues to identify ways to improve and speed up product development, medical imaging plays a more significant role. An understanding of the methodology and the metrics is therefore required but difficult to ascertain in one easy to read volume for individuals entering this field. This book will therefore fulfill this void, be it for the pharmaceutical personnel from medical director to monitor, or the Principal Investigator who is having to understand the complexities of the imaging and why it is having to be sent off-site for a 'central read.'
Part I: Overview and Trial Management.- 1. Medical Imaging Modalities.- 2. The Metrics and New Imaging Marker Qualification in Medical Imaging Modalities.- 3. Radiation Risks and Dosimetry Assessment.- 4. Imaging Review Charters and Operational Considerations.- 5. Defining the Radiological Blinded Read and Adjudication.- 6. Medical Imaging in Drug Development.- 7. Evaluating and Working with an Imaging Core Laboratory.- Part II: Therapeutic Specifics of Medical Imaging.- 8. Monitoring Responses to Therapy in Oncology.- 9. Cardiac Imaging in Clinical Trials.- 10. Neuroimaging in Clinical Trials.- 11. Imaging in Musculoskeletal, Metabolic, Endocrinological, and Pediatric Clinical Trials.- 12. Body Composition.- 13. Optical Coherence Tomography as a Biomarker in Clinical Trials for Ophthalmology and Neurology.- 14. Nuclear Medicine: An Overview of Imaging Techniques, Clinical Applications, and Trials.- 15. Contrast Agents in Radiology.- Part III: The Future of Imaging in Clinical Trials.- 16. Pharmaceutical Industry Perspective Regarding Imaging Techniques.
| Erscheint lt. Verlag | 30.1.2014 |
|---|---|
| Zusatzinfo | XVIII, 420 p. 111 illus., 57 illus. in color. |
| Verlagsort | London |
| Sprache | englisch |
| Themenwelt | Medizin / Pharmazie ► Allgemeines / Lexika |
| Medizinische Fachgebiete ► Radiologie / Bildgebende Verfahren ► Radiologie | |
| Studium ► 1. Studienabschnitt (Vorklinik) ► Biochemie / Molekularbiologie | |
| Studium ► 2. Studienabschnitt (Klinik) ► Anamnese / Körperliche Untersuchung | |
| Schlagworte | diagnostic radiology • ultrasonography |
| ISBN-10 | 1-84882-710-5 / 1848827105 |
| ISBN-13 | 978-1-84882-710-3 / 9781848827103 |
| Haben Sie eine Frage zum Produkt? |
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