The planning stage is critical to the success of any clinical trial. It sets expectations for how your team will work together to collect data, monitor results, protect human subjects and much more.
The inherent complexity of a medical device trial and the fact that it requires surgical implantation makes it especially critical to get these foundational elements right from the start. If a problem occurs, a second surgery may be necessary.
Recent high-profile recalls have spawned class-action lawsuits due to complications that occurred from a follow-up surgery, forcing the FDA to take action. In recent years, for instance, concerns over the surgical mesh required to repair pelvic organ prolapse transvaginally have prompted the FDA to strengthen the requirements mesh manufacturers must meet to demonstrate safety and effectiveness.
Most clinical professionals beginning a medical device trial are keenly aware of these issues, adding to the hurdles they must overcome before the trial even begins. Failing to clear these hurdles can slow momentum, delay approval or even compromise the integrity of the study if they aren’t addressed.
This infographic illustrates five of the most common hurdles medical device researchers are likely to face when planning a clinical trial and how to overcome them.
Researchers will inevitably encounter some of these challenges, but they don’t have to derail the study. A complex medical device trial simply requires them to take additional precautions when it comes to training their staff, reviewing data and monitoring the study. It requires vigilance to the smallest details, as there is no margin of error. Something as simple as using an outdated consent form can lead to an FDA warning letter.
That’s why device makers must do their due diligence to carefully assess anyone who touches the trial, ensure they are properly trained and create a system of checks and balances. A more in-depth look at FDA documentation protocols can be found in this whitepaper, Documentation in Device Studies.
The number of moving parts that make up a clinical trial, particularly one for medical devices, can be overwhelming—so much so that they can stall a trial before it even begins.
This infographic explores five of the most common hurdles clinical researchers are likely to face when planning a trial and how to overcome them.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.