Designing a clinical study, often faces discussions that can be traced back to the type of clinical evidence one is looking for: Are you aiming to evaluate the product effect in a controlled clinical study environment, or in a real life situation? Especially when the study product concerns a medical device, but also when it concerns food, such discussion can hold up the process of clinical trial development considerably. The main reason for this being that typically less premarket clinical studies have been done, and therefore less efficacy data is available when the product is brought to market.
An impression on the main areas of discussion you can find in the presentation here. In short the main areas leading to a debate include the following:
- Study population – how strict should the in- and exclusion criteria be?
- Treatment – what benefit do you want to prove?
- Duration of patient follow-up – how long does the effect last?
I will be posting more in depth discussions on each of the items above, so stay tuned when you consider this a topic of interest. Feel free to raise any questions or topics you would like me to address in this context or otherwise.