I’m considering using a similar study design from another company to expedite the regulatory clearance process for my new device. Can’t I just copy that company’s study design since our devices are similar?
No, No, and No ❌
Ok fine, while it might save time, there are important drawbacks to consider:
- Missed opportunity to showcase the novelty of your invention
- Overlooked gaps in the original design, that wasn’t public information
- Legal, ethical, or compliance issues you may not be aware of from the original design – or implications that could impact your company
Going to market with a “me-too” product could significantly reduce the chances of market success.
It’s crucial to carefully weigh the pros and cons of copying a clinical trial design.
The era of one-size-fits-all is over!
