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Simplifying Clinical Trials

Definition:  For the purposes of this blog, we will use the NIH definition, modified for medical devices.

Clinical Trial – Biomedical research study of human subjects designed to answer specific questions about biomedical interventions.  Clinical trials are used to determine whether new biomedical interventions are safe, efficacious and effective.

Clinical trials of an experimental medical device or intervention may proceed through four phases.

Phase 0 – Designed to speed up promising drugs or imaging agents by establishing early whether the drug or agent acts in human subjects as would be expected from pre-clinical (animal) studies.  Usually omitted from medical device trials, especially if the device is not implanted, is constructed from FDA approved biocompatible materials or is classified as low-moderate risk (Classes 1&2). It is assumed that product design controls have verified that we have built the appropriate product and validation has confirmed the product meets the intended clinical need.  It is further assumed that pre-clinical work has established indications for use and principles of operation.

Phase I – The device is tested in a small group of subjects (perhaps 20-80) to determine safety and efficacy.

Phase II – The device is tested in a larger group of subjects (perhaps several hundred) to further determine safety and efficacy.

Phase III – The device is studied in a large group of subjects (hundreds to thousands) by comparing it to standard or other interventions, to monitor adverse effects and further determine safe useage.  We may also wish to modify the protocol to add the gathering of cost data, useful in seeking reimbursement.

Phase IV – Post market surveillance studies to monitor effectiveness of the approved device in the general patient population and determine any adverse effects associated with widespread use.

Most medical devices proceed to market through the FDA clearance to market 510(k) process and do not require the above trials. Yet, proposed changes to the 510(k) process coupled with the increasing need to prove cost effectiveness compared with other interventions is likely to require more clinical trials for devices than was sufficient in the past.

Protection of study participants is paramount, so clinical trials are conducted with significant oversight.

A key element of clinical trials is protection of study participants and the patients who may use the device in clinical practice.  Clinical trials regulatory principles are mandated by the FDA and Good Clinical Practice Guidelines, while human subjects protection is overseen by the Institutional Review Board (IRB), principally through the informed consent process.

In part 2 of this series we will discuss human subject protection, the role of the Principal Investigator (PI) and Standard Operating Procedures (SOPs) in implementing the study protocol in compliance with regulations and guidelines.

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