Joel Reid, Regulatory Affairs Specialist, dissects the different facets of this relationship, shedding light on why sound regulatory practice is absolutely essential for the success of clinical trials.
Can't watch right now and rather read a quick summary? Here is a recap of what Joel shares in the video:
Hello, Joel here from the team at Proxima CRO.
In this video, we're going to explore how proper clinical trial design and management are critical to the success of regulatory submissions!
As a scientific study that evaluates the safety and efficacy of a product, clinical trials are a big step in bringing a new drug or medical device to market. Trial design and management can also have a major impact on the success of regulatory submissions.
The clinical trials should be based on sound scientific principles with the appropriate endpoints, patient population and study duration to generate the data required to support the regulatory submission. A poorly designed or managed clinical trial can result in inadequate or incomplete data, which can delay or even prevent regulatory approval.
To ensure the validity of the data generated by a clinical trial, knowledge of regulatory expectations is imperative because these endpoints can impact the overall trial design. These expectations may include elements such as the need for adequate control groups, patient inclusion and exclusion criteria, endpoints and statistical analyses.
Adherence to regulatory guidance and agency input will result in a better designed and executed clinical trial, which will generate data that is more likely to be accepted by regulatory agencies. This will reduce the risk of additional studies or data being required, ultimately speeding up the approval process and bringing the product to market more quickly.
There are also many considerations and potential problems that can arise during clinical trial execution that can impact the regulatory review. For example, inadequate patient recruitment can lead to a lack of statistical power, making it difficult to demonstrate the safety and efficacy of the product. Improper management of clinical data monitoring may result in insufficient data collection, which can lead to missing important safety or efficacy endpoints.
And finally, protocol deviations or noncompliance can lead to data that is not reliable, resulting in the regulatory agency rejecting the data or requiring additional studies. These problems significantly increase costs and time to market, and in the worst case scenario, the regulatory agency may reject the data altogether, resulting in a complete halt to the approval process and the requirement of a new submission.
So don't cut corners when it comes to your clinical trials. This is one of your biggest milestones and important data points. Your best bet is to align yourself with a CRO like Proxima that has the knowledge and experience to help design and execute clinical trials that adhere to any regulatory requirements.
See the difference a next gen CRO can make by visiting us at proximacro.com.