What is clinical research? Clinical research leads to medical advances for everyone no matter the age. Clinical research can happen at home, in a doctor’s office, research lab/hospital, and online. The length of research varies depending on the research. Clinical research includes healthy volunteers and volunteers with a disease or disability. What are clinical trials? Clinical trials are clinical research that deals with medications, epidemiology, procedures, behavioral health, and health services.

            Why do people participate in clinical trials? People participate in clinical trials to improve and understand diseases, the patterns, the causes, and effects of health and disease in specific ages, ethnic, and other groups. It’s also important to understand human behavior and to improve human behavior with treatments and medications. This can also help improve healthcare costs and healthcare services. This can also help how clinical trials evaluate the effects of health outcomes when it comes to health intervention and new ways to improve the quality of life.

            Diversity in clinical trials is important due to differences in experiences but with the same diseases. Diversity includes living conditions, race, age, sex, sexual orientation, access to healthcare, pollution in the area, and even life experiences. The clinical trial protocols are the goal of the study, subject eligibility, risk protections, details on the procedures, treatments, and tests, trial duration, and information that will be gathered. The Institutional Review Board (IRB) monitors most clinical trials here in the United States to ensure fewer risks are happening. There are different types of clinical trials: prevention trials, screening trials, diagnostic trials, treatment trials, behavioral trials, and quality-of-life trials.

            There are observational studies and there are clinical trials, and both are different. The observational studies are case studies and case series, ecological studies, cross-sectional, case-control studies, and cohort studies. The clinical trials are Phase I, Phase II, Phase III, and Phase IV trials. The Phase I trial tests a drug or treatment treating 20-80 subjects, Phase II trial tests new drugs or treatments given to a larger group of treating 100-300 subjects. Phase III trials are the new drug or treatment for large groups treating 1,000-3,000 subjects and the Phase IV trials are after a drug is approved by the FDA.

            In today’s study, Dyese Taylor at Icahn School of Medicine at Mount Sanai conducted a research study on pregnant and postpartum patients and their responses to anti-hypertensives Nifedipine and Labetalol via intravenous (labetalol) or via oral (nifedipine). There were 109 participants in this interventional clinical trial which makes it a Phase IV clinical trial. The primary purpose of this study is to treat pregnant and postpartum patients with hypertensive diseases such as hypertension, preeclampsia, and eclampsia with blood pressure that is greater than 160/110. The oral nifedipine was given in dosages of 10mg and 20mg while the intravenous labetalol was given in dosages of 20mg, 40mg, and 80mg. Only 55 participants were given intravenous labetalol and 54 participants were given oral nifedipine. The NIH website would be useful for people who work in the clinical research field because there is more information on research topics, and this could help a researcher learn side effects and possibly come up with another way to go for their study. I entered preeclampsia in the search bar, completed the status of recruitment, and the study results is selected with results.

Resources

·      Taylor, Dyese, Icahn School of Medicine at Mount Sanai. 2021, May 24. Response to Anti-Hypertensives in Pregnant and Postpartum Patients. Retrieved from https://clinicaltrials.gov/ct2/show/study/NCT03506724?recrs=e&cond=Preeclampsia+and+Eclampsia&phase=3&draw=3&rank=18

·      National Institutes of Health. 2016, September 29. What is Clinical Research? Retrieved from https://www.nih.gov/health-information/nih-clinical-research-trials-you/what-is-clinical-research

·      Dyese, Taylor, Icahn School of Medicine at Mount Sinai. 2021, May 24. Response to Anti-hypertensives in Pregnant and Postpartum Patients. Retrieved from https://beta.clinicaltrials.gov/study/NCT03506724?tab=history

·      National Institutes of Health. 2022, October 3. The Basics. Retrieved from https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics

·      National Institute on Minority Health and Health Disparities. 2022, February 7. Diversity and Inclusion in Clinical Trials. Retrieved from https://www.nimhd.nih.gov/resources/understanding-health-disparities/diversity-and-inclusion-in-clinical-trials.html