Retrospective Data for Clinical Evidence - Look Back to Move Your Product Forward

Requirements for clinical evidence of medical device safety and performance are increasing globally. Not only in Europe, but in Australia and the United States. If you read my last blog post, the U.S. FDA is exercising its broad authority to require clinical data for 501(k) submissions. If you haven’t done a premarket clinical trial, how are you going to find clinical data in time to meet your regulatory submission requirements?

For devices that have already been on the market in the United States, you may have an option you hadn’t thought of: a retrospective observational research study. This option is particularly useful for implants, but can be used for any medical device used by or prescribed by a clinician in the United States. Simply put, you can tap into existing medical records to gather sufficient clinical evidence of the safety and efficacy of your device. You just have to make sure you do it the right way. 

In the United States, we often sign a document when we go to the clinic or consent for surgery that waives our rights under HIPAA. This HIPAA waiver allows the clinic or hospital to share your medical data for needs related to your care. But, often, this waiver contains language along the lines of…”your medical data may be used for the purposes of research”. If that language is in a clinic document signed by patients who are being treated with your medical device, you can create an IRB approved retrospective research study with waiver of consent to gather data to support your device. 

Assuming there is a waiver that allows sharing of medical data, you will need to create a study protocol for your retrospective study. This protocol must have all the requirements one might find in a clinical study. I refer you to ISO 14155 for guidelines on an appropriate Clinical Investigation Protocol. Your study must lay out the basis for a consent waiver, which is codified in 45 CFR § 46.116. This clinical protocol must be IRB approved by a central or institutional IRB prior to conducting data collection. Clinical studies of any kind focused on medical devices should always be listed on clinicaltrials.gov (listing your PMCF study in a database is a requirement under EU MDR). 

Using a retrospective clinical observational study for your clinical evidence requirements is a good way to collect historical data on the safety and efficacy of your device without needing a long-term prospective study prior to market authorization under the new clinical evidence requirements. For long-term safety data, it may be possible to convert your retrospective study patients into prospective long-term follow-up with informed consent by adding a prospective arm to your study once your retrospective data is collected. 

While a retrospective study is a solution for many manufacturers, there are limitations. Under GDPR, this type of retrospective study cannot be performed in EU countries or the UK. The rules under GDPR for specific consent are much more strict. It is also critical that patients have signed some waiver or clinical consent document that allows for sharing of their medical record data for research. That said, this observational research method may be a cost-effective time saver for medical device companies looking to bring their Class IIa, IIb, and III devices to the EU under MDR or other jurisdictions that require clinical evidence.