Recent widespread recalls of investigational products have led to harsher scrutiny and stricter rules from the Food and Drug Administration (FDA). Steps take to prepare for trials in the past are no longer enough. The path to FDA approval requires tremendous organizational skills and attention to detail to navigate; but with the right preparation and commitment to compliance, all of these challenges can be overcome.
If your clinical trial is complex you cannot afford to be derailed by complications or setbacks. To help those in the medical device industry gain better footing, preparation, and knowledge, IMARC published a whitepaper highlighting the top five key areas that can complicate medical device trials as well as tools for overcoming these complications.
- Medical Device Experience - How much experience do you have operating under 21 CFR 812? Not all clinical trials are created equal; in fact, there are many differences between drug and device trials.
- Sponsor-Investigator Trials - Are you planning on using and/or acting as both sponsor and clinical investigator of your trial? Do you know what is required by FDA?
- Global vs. US Based Clinical Trials - As one can imagine, doing business globally presents many challenges, regardless of the industry. For clinical trials, specific factors must be taken into account to run a well-controlled, compliant study.
Medical device trials require constant vigilance and the capability to capture even the smallest details and act on them if necessary. Compliance failures, whether through grossly inadequate monitoring or something as simple as using an outdated patient consent form, account for most FDA warning letters.
Know the ins and outs of your clinical research study. Be prepared for all the complications that may be obstacles along your pathway to approval.
Can you think of other points that may complicate a clinical trial? Share them below, we’d love to have dialogue on this topic.
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