The placebo effect can complicate clinical trials because it makes it harder to tell whether improvements in patients are because of the actual drug or the belief in the treatment. The psychological response can hide the effectiveness of a medication,…   Read more»

I think participants in pharmaceutical trials should receive compensation in some situations if it is ethical. The compensation should be based on the type of risk and time that the trial is. I think there should be a screening process…   Read more»

I think they should be given payment because it is still a risk that they are choosing to take and there are of course possible benefits of partaking in the medication, but the risks of it being harmful are far…   Read more»

I feel a standardized procedure may be hard to define as the research is quite different depending on the device that is being tested, so it can be harder to find a method that can work for everyone. However, I…   Read more»

I agree with what has been said about negative results if the placebo effect seems to be helping patients because it seems to disprove the actual use of the medication. If the placebo group were to do better in comparison…   Read more»

I really like your choice of wanting to be a Clinical Investigator. Investigators have a key responsibility in clinical research; they not only enroll and treat subjects but also make sure informed consent is obtained and that adverse events (AEs)…   Read more»

I see what you mean; it might seem like a single-blind study should be enough. However, according to this week’s notes, bias can occur not only from the patient but also from the investigator. In a double-blind study, both the…   Read more»

I agree that clinical studies are essential despite their risks. According to the Week 5 slides, clinical research is the only way to determine how a medical product, device, or drug truly works in humans, since not all results from…   Read more»

Clinical studies have many benefits, one of which is that they give researchers firsthand information on how a medication or gadget works in people. We wouldn’t have access to vaccines, life-saving therapies, or medical advancements that have enhanced global health…   Read more»

On the surface, it might appear that a single-blind research should be sufficient to minimize bias because only the patient is unaware of whether they are receiving the actual medicine or a placebo. Double-blind studies, on the other hand, are…   Read more»

Your justification for wanting to work as a clinical investigator is excellent; it’s a very important and esteemed position in clinical research. It would be your responsibility as a clinical investigator to make that the study is carried out ethically,…   Read more»

Patients participating in a study should generally be compensated in some form, including financially. This is dependent on several factors, namely the phase of the study and the severity of the preexisting condition(s) they have been selected for.   For…   Read more»

I think having a standardized process for handling adverse events is essential, but it should also include build-in flexibility. Each trial is different, and the severity or nature of an event might require a unique response. A clear chain of…   Read more»

I really agree with what a lot of people here have said about the gap between classroom learning and real-world clinical experience. I think spending time in a clinical setting would make a big difference for biomedical engineering students, not…   Read more»

I think another interesting angle that hasn’t been mentioned yet is how the placebo effect can actually reveal the power of patient-clinician interaction rather than just being seen as an obstacle in data collection. In some cases, the way a…   Read more»

If I was involved in clinical research trials I would like to work as a Clinical Research Coordinator. This position seems interesting because coordinators are responsible for organizing the daily activities of a clinical trial and making sure everything runs…   Read more»

When design control is used insufficiently, several serious issues can arise during the development of a medical device. One major problem is that design requirements may not be clearly defined, leading to products that fail to meet user needs or…   Read more»

A company that comes to mind would be Theranos; the health technology company that claimed to have developed a revolutionary blood-testing device. The company allegedly manipulated and hid failed verification and validation results to make their technology appear more reliable…   Read more»

Yes, I definitely feel safer knowing that validation and verification are key and required steps in the development of medical devices. These processes ensure that devices not only meet design specifications but also function correctly in real-world medical settings and…   Read more»

I think there are many reasons why people decide to join clinical trials. Some people participate because they want to help advance medical research and make new treatments available for others in the future. Others might join because they have…   Read more»