Source: https://clinicaldevice.typepad.com/cdg_e_conferences/registry-study-designs.html
Timestamp: 2020-08-04 17:46:36
Document Index: 638999299

Matched Legal Cases: ['art 812', 'art 812', 'art 812', 'arts 50', 'art 812', 'art 812', 'art 812', 'art 812']

CDG e Conferences & Workshops: Registry Study Designs
Registry Study Designs
What is a medical device "registry"?
"Registries" are a broad category of human research designed in dozens of ways for dozens of reasons. Hospitals keep registries to monitor patient infection rate by surgical suite or by surgeon. Device manufacturers might keep registries for any of the following reasons:
[1] To study the effectiveness of a device in real-life medical practice.
[2] To learn how treatment with one device compares with other treatments in a population with a given condition.
[3] To study the nature, severity, and frequency of occurrence of adverse events and adverse device effects.
[4] To gain information for new indications or claims.
[5] To gain information to support reimbursement applications.
The number of reasons for conducting registries is endless; but every registry begins with a clearly stated purpose.
Characteristics of registries
Registries have certain characteristics that distinguish them from clinical trials, and these distinctions bring with them more flexibility in design and implementation.
Most importantly, the device under study must be cleared for commercial sale; if it isn't, the research activity is a clinical trial and may be subject to 21 CFR Part 812. If the study is exempt from Part 812, many record-keeping and reporting burdens go away (unless, of course, the study is required under the Post-Market Surveillance provisions of Section 522 of the Act.) Note that exemption from Part 812 does not include exemption from Parts 50, 56, or HIPAA.
Since the goal of a registry is always to learn about the device in actual use--its effectiveness as opposed to its efficacy--investigators should be instructed to use the device exactly as they normally do. Thus, a registry is an observational study, without active intervention, and we would say that the registry is data-driven rather than protocol-driven.
However, it leads to an interesting regulatory question. Part 812(2)(c) tells us that a study is exempt from Part 812 if it has a cleared 510(k) and is used per the approved indications and labeling. But if the investigators are using the device as they normally do, it is possible that some uses may be "off-label". Does this possibility revert the registry to a clinical trial?
Inclusion criteria are as broad as possible, with almost no exclusion criteria at all. You are seeking to study patients as they exist in real-life, with multiple complications, co-morbidities, or treatments. In this way you can extrapolate the data from the study sample to the general population and make better arguments for reimbursement.
Finally, you can design the registry study as disease or condition centric and recruit all patients with that particular disease or condition. Then you gather data to see how often, in real-life, your device is selected as the treatment option and why.
Why take this eConference?
Many device manufacturers conduct registry studies. While some are required as post-marketing surveillance studies under Section 522 of the Act, the vast majority are implemented voluntarily with the expectation of some research or marketing gain from the data.
But the regulatory status of registries is always a little hazy. When do you need IRB approval? Can you use central IRB approval in a hospital? When do you need informed consent? When can you ask for a HIPAA waiver of authorization? Do you have to monitor a registry study? Can you monitor a registry study? Can your monitor source verify data? How do you assure you don't cross over the line from a Part 812 exempt registry trial and into the jaws of Part 812 regulation?
In this eConference we'll examine these questions and many more as we explore the complexities and flexibilities of medical device registries.
[x] Clinical research professionals who are involved in registry studies.
[x] Regulatory professionals struggling with the unique regulatory status of registry studies.
[x] Marketing professionals who need registry studies for publication or other marketing purposes.
Dr. Nancy J Stark is President of Clinical Device Group, a consulting and contracting firm for medical device pre-approval issues. You can read about Dr. Stark at www.nancyjstark.com and about Clinical Device Group at www.clinicaldevice.com.
The purchase is $429 for OnDemand access and $479 for the CD. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.