I find it fascinating how researchers try to keep the placebo effect from skewing the results. One of the main methods is blinding. In single-blind trials, participants don’t know if they’re getting the actual treatment or a placebo, and in…   Read more»

From my understanding, if a study is properly designed with an actual placebo control group and a treatment group, and the treatment provided to the treatment group was also a placebo drug it should be pretty much impossible for that…   Read more»

Clinical trials are so controlled that they sometimes fail to show how a treatment works in real-world settings. Things like a person’s lifestyle, environmental influences, or even how consistent they are with their meds can have a huge impact. Plus,…   Read more»

Environmental factors can play a huge role in clinical trials, creating effects that wouldn’t be seen until a larger role out happens and post market research is done. For instance, if a pain study is done in a small country…   Read more»

One of the biggest challenges with multi-center clinical trials is keeping everyone on the same page. Since these trials are all about gathering a lot of data quickly, it’s super important to have clear expectations to ensure that all the…   Read more»

Placebo must be controlled at the group level in order to ensure results are not biased because of it. One group should be set aside and receive placebo treatment for their pain, while the other group should receive actual medication….   Read more»

I believe the placebo effect will vary a lot within the group of test patients who are have placebo treatment. This can be one sign because as said in the lecture, it really depends on the patients’ expectancy and I…   Read more»

There are a lot of things that the clinical trials cannot show that I believe are important as well but you cannot start modifying and improving the drug until it reaches more patients so clinical trials are the best we…   Read more»

Interestingly, researchers have made it easier to find clinical trials nearby and figure out what to expect if you participate. Clinical trials are crucial in medical research because they help ensure that treatments are safe and effective before the FDA…   Read more»

Clinical trials are so important for ensuring we develop safe and effective treatments. One treatment that comes to mind is carotid artery stenting (CAS) for patients with narrowed arteries in their necks. This procedure helps reduce the risk of stroke…   Read more»

This is a very interesting prompt to start with. However, I do not think the drug, if it is truely a placebo, will be approved by the FDA. It will involve ethic issues since most of the clinical trials, if…   Read more»

Another benefit of blinded studies, especially double- or triple-blind designs, is the reduction of the placebo effect. In cases where participants know they’re receiving a treatment, there’s a psychological tendency to perceive improvement due to expectations, regardless of actual effectiveness….   Read more»

Another essential testing process in clinical research for the medical device industry is the Investigational Device Exemption (IDE). This exemption allows a medical device that’s still under investigation to be used in clinical studies to collect safety and efficacy data…   Read more»

When addressing unexpected adverse events in clinical trials, I think a combination of predefined protocols and event-specific flexibility is essential. Standardized guidelines set a clear baseline for accountability and efficiency, ensuring everyone knows their roles and responsibilities in routine scenarios….   Read more»

Hi sn64,Clinical trials may miss long-term side effects, rare adverse reactions, and interactions with other medications due to limited sample size and other factors. Also, they can lack diversity in age, ethnicity, and health conditions, which can show if the…   Read more»

Hi smitshah,Double-blind studies are critical because they prevent both patient and investigator biases which can affect the study outcomes. If the investigator knows who is receiving the active drug or placebo, they could possibly interpret patient responses. This bias is…   Read more»

Hi amd29,I feel as if clinical testing of pharmaceutical drugs is ESSENTIAL to assess their safety, efficacy, and potential side effects. Unlike medical devices, drugs interact with the body in complex ways, so testing helps ensure they work as intended…   Read more»

@krp67 To add onto this and emphasize you’re point; yes these drugs do need to go through animal trials first, but they then must be confirmed with human trials. As you mentioned, the human body is not exactly one to one…   Read more»

A double blind study greatly improves the authenticity of the study results and removes bias from both and patient and Investigator involved. To give an example, if you provide a swatch of color to a person and ask what color…   Read more»

Having a clinical background seems to be used as a filter by many companies to recruit talent with a certain background and make it so those who do apply without that experience and get in-are exemplary. From that perspective, I…   Read more»