Abstract
Clinical trials play a very crucial part in the process of bringing devices, specifically heart valves, to the market and for providing continued scientific clinical data after commercialization (Fig. 17.1). Prior to executing a clinical trial, researchers typically do not know how the newly developed valve will perform in a human body. Further, it should be noted that many patients that receive these class III life-sustaining devices will likely have many other clinical complications that, in some cases, may adversely affect the potential success of novel technologies. Therefore, carrying out a carefully designed clinical trial is an important opportunity to examine outcomes of the new valve in humans and to provide resultant clinical data to patients, physicians, and the entire scientific community. Yet today, the primary purpose of such a clinical trial is to provide valid scientific evidence about the safety and/or efficacy of a device, resulting in clinical evidence for future use or retraction of a therapy.Fig. 17.1 Timeline of medical device development
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Abbreviations
- CE:
-
“Conformité Européenne” or European Conformity
- CEC:
-
Clinical Events Committee
- CFR:
-
Code of Federal Regulations
- DSMB:
-
Data Safety Monitoring Board
- EC:
-
Ethics Committee
- EOA:
-
Effective orifice area
- FDA:
-
Food and Drug Administration
- GCP:
-
Good Clinical Practice
- GLP:
-
Good Laboratory Practice
- GMP:
-
Good Manufacturing Practice
- IDE:
-
Investigational Device Exemption
- IRB:
-
Institutional Review Board
- ISO:
-
International Organization for Standardization
- OPC:
-
Objective performance criteria
- PMA:
-
Premarket approval
References
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U.S. Food and Drug Administration (January 20, 2010) Draft Guidance for Industry and FDA Staff Heart Valves—Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications Draft Guidance. http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm198043.pdf. Accessed 8 June 2012
International Organization for Standardization (ISO), ISO 5840:2005, “Cardiovascular Implants—Cardiac Valve Prostheses” (ISO 5840)
Kaplan AV, Baim DS, Smith JJ et al (2004) Medical device development: from prototype to regulatory approval. Circulation 109:3068–3072
U.S. Food and Drug Administration (January 14, 2011) Good Clinical Practice 101: An Introduction. http://www.fda.gov/Training/CDRHLearn/ucm176411.htm. Accessed 8 June 2012
Centers for Medicare & Medicaid Services (2012) Medicare Clinical Trial Policies. https://www.cms.gov/ClinicalTrialPolicies/. Accessed 8 June 2012
Centers for Medicare & Medicaid Services (2012) National Coverage Determination (NCD) for Routine Costs in Clinical Trials (310.1)—Current Policy—July 2007 NCD. Medicare Clinical Trial Policies. https://www.cms.gov/ClinicalTrialPolicies/. Accessed 8 June 2012
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Iaizzo, J.C., Lovas, A.T.F. (2013). Clinical Trial Requirements for Cardiac Valves. In: Iaizzo, P., Bianco, R., Hill, A., St. Louis, J. (eds) Heart Valves. Springer, Boston, MA. https://doi.org/10.1007/978-1-4614-6144-9_17
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