A medical device company files a marketing application with FDA and awaits a determination on
whether or not its clinical trial data is sufficient to support product approval and/or clearance.
Modern companies cannot operate today without a quality system and if they are sponsoring clinical research, oversight of clinical studies should fall under their quality system. CDRH conducts on the order of 300 Bioresearch Monitoring (BIMO) inspections per year and annually publishes details of its inspectional findings in medical device trials. Year after year, the following items are commonly cited:
| Sponsor Inspections | Investigator Inspections |
| Inadequate monitoring | Failure to follow investigational Plan or Regulations |
| Failure to secure investigator compliance | Protocol Deviations |
| Inadequate Device accountability | Inadequate subject protection and Informed Consent |
| Obtain FDA/IRB approval | Inadequate Device Accountability |
As clinical research professionals, what can we do to improve these findings? I have a few thoughts…
- Create and implement a monitoring plan that combines on-site with remote monitoring activities. Use on-site monitoring more frequently early-on to check on study start-up at the site. Be on-site to answer questions and re-train as needed on screening and eligibility, consenting, the protocol and data collection as the first few patients are enrolled. This will address initiation issues early on and demonstrate the Sponsor’s commitment to compliance. As the study progresses, remote monitoring can be utilized to routinely check for data omissions,
outliers and clerical errors and to keep sites aware of and on track with protocol required follow-up visits. - When working with “must have” investigators, keep in mind that they are the thought leaders in the target field of research. These men and women have assumed a leading role in the constantly dynamic research environment. They may need, on occasion, to be reminded that trial data collected under a multi-center protocol needs to be poolable and collected with a goal of zero protocol deviations.
- What is it about device accountability inadequacy that makes it appear as a common inspectional finding? We need to dig down to help Sponsors and Clinical Investigators understand and address this inadequacy gap.
- Last, but certainly not least, is protecting human subjects. Clinical research would not happen without subject volunteers. We need to do everything we can to make sure that subjects have complete and current understandable information regarding the risk/benefit of the studies in which they’re volunteering to participate. From screening through
last visit, we must be ever vigilant of their rights,safety and welfare.
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Photo Credit: Leo Reynolds
