While virtual trials can help with reaching as many patients as possible, this approach has drawbacks to it as well. The main benefit of virtual trials is of course, the ability to reach the maximum number of possible participants across…   Read more»

I agree that Good Clinical Practice (GCP) is essential for maintaining ethical standards and protecting patients, but I also see how it can sometimes feel overly focused on documentation rather than the people participating in the studies. The guidelines are…   Read more»

You raise a really good point — it does seem at first that a single-blind study, where only the patient doesn’t know what they’re receiving, should be enough. However, the reason double-blind studies are preferred is to remove investigator bias…   Read more»

If I worked in clinical research, I would like to have the role of a monitor. Monitors have the role of ensuring clinical trials are run safely and ethically, that data is accurate and reliable, and that patients’ rights are…   Read more»

The placebo effect is a great example of how phycological and physiological systems in our bodies are so deeply intertwined with each other. This makes it both a challenge and a learning opportunity in clinical research and study. Viewing it…   Read more»

The placebo effect is a fascinating and challenging aspect of clinical research because it highlights how powerful the mind-body connection can be. When patients receiving a sham or inactive treatment (placebo) report improvements similar to those receiving the actual drug,…   Read more»

In my opinion, a single-blind study could work in a majority of the cases since the researchers/investigators do not really have significant effect on the results of the study most of the time. However, this may not be true sometimes…   Read more»

The placebo effect can make it difficult to tell whether improvements in patients are due to the actual drug or simply their belief that they are receiving treatment. To differentiate, results are compared between the placebo group and the active…   Read more»

I completely agree that GCP guidelines are done correctly in terms of safety and efficiency. GCP is extremely important in ensuring the validity of a medical device, drugs, etc. Protecting patients is the number 1 responsibility of a clinical trial,…   Read more»

Biomedical engineers I believe play a significant role in clinical research and can be the bridge to piece a lot of aspects together. The background in the field has big focuses on design controls, systems thinking and even data analytics;…   Read more»

While clinical research can feel like it’s being weighed down by the scope of the idea or complexity, every process and layer within it from approval and documentation to analysis is there for good reason. The challenge I think lies…   Read more»

I would prefer to be a monitor (clinical research associate) of clinical research because it seems very interesting to do their job. A monitor basically monitors the procedures, data sets, and accuracy of the experiments that occur. This is similar…   Read more»

I actually think double blind studies are essential in many cases because they minimize both participant bias and investigator bias, which can unintentionally influence the results. Even the most experienced researchers may subconsciously affect outcomes when they know which patients…   Read more»

Personally, I would be more interested in the role of a Clinical Research Coordinator (CRC). The CRC is often the backbone of the trial and is responsible for handling data collection, maintaining documentation, scheduling participants, and ensuring compliance with both…   Read more»

While many GCP guidelines involve extensive documentation, I believe they are absolutely necessary to protect patients participating in clinical trials. These standards are the foundation for building trust between patients, physicians, and researchers as new medical innovations emerge. They protect…   Read more»

Medical device development takes several years to complete, and drug development can take over a decade to complete. The clinical trial process has become more complex and expensive, as mentioned. Challenges include the need for more procedures & tests, longer…   Read more»

GCP is absolutely necessary because innovation is useless, if the methods used to essentially prove the device are not sound. While GCP does involve much more extra paperwork, that causes things to take much longer and also cost more money,…   Read more»

I agree with you, that trust is absolutely vital in a clinical study, not only to attract and retain participants, but to also ensure that the patients report honestly. I believe that the best way to build to maintain trust…   Read more»

I understand the concern about the risks involved in clinical studies, but I believe that human clinical trials are absolutely necessary and ultimately do far more good than harm. Without them, there would be no safe or effective medical devices,…   Read more»

For the protection of human research subjects, regardless of the type of research, there is 45 CFR 46, which pertains to the Department of Health and Human Services. This regulation was also adopted by other agencies and departments, which is…   Read more»