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»

Participating in a clinical trial is a meaningful way to contribute to the development of new treatments potentially shaping the future of medicine. Modern tools make it much easier to search for trials near your location, learn about the study…   Read more»

While clinical trials are critical for evaluating the safety and efficacy of a product, they often lack in participant diversity and the real-world complexity required to paint a full picture of product performance. Some specific issues or trends not seen…   Read more»

Effective coordination and communication are essential when adverse events occur in clinical trials. Maintaining clarity between investigators, sponsors, IRBs and CROs is essential. In my opinion, using a hybrid approach would be effective. Combining standardized protocols with some flexibility for…   Read more»

This is an interesting prompt. I seriously question if this product will be able to be brought to market. One of the requirements of a product is that it must solve a problem and is effective. In this case, it…   Read more»

In clinical studies, it is extremely evident that diversity is necessary in order to properly represent the possible effects of the product or drug on all peoples. If diversity is needed in the results, the diversity is needed in the…   Read more»

I have always been fascinated by the concept of placebo. The fact that it is possible for the brain to allow suffering of healing, based on itself, is almost mind boggling. There are attempts to minimize the effects of placebo,…   Read more»

This is a very interesting topic because controlling the placebo effect in clinical research is critical to the success and accuracy of a trial, especially in studies in which the patient’s perception of pain can heavily influence the results. While…   Read more»

People decide to participate in clinical trials for a variety of personal and medical reasons. To start from a medical perspective, one of the main reasons individuals volunteer in clinical trials is because it gives them early access to new,…   Read more»

As a graduate student-athlete who is pursing their Master’s in Biomedical Engineering at NJIT, I definitely think that students would greatly benefit from spending time in a clinical setting. Throughout my past four years at NJIT, I have found it…   Read more»

Blinding is a very useful method for researchers to minimize the placebo effect in clinical trials. In single blinding, participants do not know whether they are receiving the active treatment or a placebo. In double blinding, neither the participants nor…   Read more»