Clinical trials are very crucial to medical device development, they serve as prediction in a sense to how effective the device can be within the market. I believe its important that a clinical trial provides substantial data to prove that it is an asset to the public. My question is what is your idea of substantial data? How many trials should be ran? Also if a clinical trial seems to provide negative data, when should a project team scrap the idea?
Clinical trials are a decisive method to evaluate the safety and efficacy of a device before they hit the market. "Substantial data" to me is more than just the quantity of tests run, but the quality of the tests and how effective the trials are at providing relevant data. When collecting data, there are a couple of variables that need to be considered: population size, diversity of the population (in terms of age, race, sex, etc.), and the relevancy of the data being collected. The number of trials conducted can directly correlate to how complex the device is. The more risk associated with the device, the more trials should be conducted to ensure its safety and efficacy. But again, the point is despite the number of trials, the results should be relevant as well as consistent. If clinical data is inconsistent or irrelevant, then the clinical trial, if not the entire project, must be redone with significant changes made. Scrapping an idea is a difficult thing to do when a project has progressed so far as to be completing clinical trials. Unwanted results from clinical trials are not inherently a bad thing. It may delay the project and increase cost significantly, but it is a crucial indicator that there is a major flaw within the device itself. Scrapping the project entirely has many factors that have to weigh into the decision: sunk-cost fallacy, how significant is the change that needs to be made, changes to the timeline of the project, what or who is affected by the continuation or abandonment of this project.
As stated before, when talking about "Substantial data" it does not just mean the quantity of the trials. Quantity really only depends on how complex the the device is. My idea of "substantial data" is whether or not it gives back clinically relevant feedback. In other words, do the results of the trials give information that will be able to help the device or prove the device works. If the results are not clinically relevant and return negative findings, see how the results affect the safety, efficacy, and patient outcomes of the device. If each of these respond negatively, the device may have flaws in its design and/or functionality. Also, 'the data should be compared to the market and the competitors to see if it is actually substantial. If it is providing similar results as a competitor is it really substantial data? Overall, to understand whether or not a medical deice provides substantial data or should be scrapped should be dependent on many different comprehensive assessments of the device.
Substantial data in clinical trials is the evidence that demonstrates the device's safety and efficacy. The quantity and quality of data would be based on the complexity of the device and the regulatory requirements implemented. In a normal clinical study, multiple trials would be done including randomized controlled trials (RCTs). If the trial yields negative results, indicating the device's ineffectiveness or risks, the team or individual should evaluate the findings and consider the possibility of modifications. It is important to take into account patient safety and commercial viability before determining whether to continue with the project or abandon the idea. In my personal experience, the initial step is to make an alteration, and if that also results in negative data, other courses of action would be necessary.
This is a great discussion because clinical trials are indeed extremely important to the release of many life saving medical devices on the market today and all that will be released in the future as well. As to how many trials should be run and when a project team should scrap the idea, I believe this highly varies from project to project. To me, substantial data itself refers to the actual quality of data and whether it supports the claims of the medical device. This substantial data is what would be used by regulatory and the FDA to determine the risk factor of the device and whether it can be deemed as usable in the industry for patient use. The guidelines of what makes up substantial data can also vary on the type of testing and nature of the device in question, so there is a lot of variation when it comes to this subject.
The number of clinical trials can not be fixed. It varies from one to another. The number of clinical trials depends on several factors such as the nature of the device, patient population, regulatory requirements etc. It might happen that only one clinical trails is sufficient. On the other hand, it might also happen that numerous clinical trails are required.
Secondly, negative data, indicating that the device is not effective or safe. Then, the project team has to find out the exact cause of this. If the cause is minor then the project team can find a way to resolve the problem. On the other hand, if the problem is a fundamental error related to the problem then the project team has to redesign the project.
