Experimental Studies Heart Disease And Diabetes
Every experiment in the United States has to be registered with ClinicalTrials.gov. Visit the clinical trials website. Select Heart disease and Diabetes. Search these disease in clinical trials. Select a clinical trial that is currently going on with this disease.
a. 300 - 500 words, describe the clinical trial, inclusion, and exclusion criteria.
What phase is this trial?
Is it single or double blind?
What methods does it use (Random Clinical Trial, Community Intervention, Pre/post method or single group design). Based on what you have read in the textbook, what do you think are the limitations of this trial based on what is written in the clinical trials summary of the methods.
Sample Solution
The clinical trial I selected is called “A Study of Alectinib in Combination With Placebo for the Treatment of Patients With Metastatic Heart Disease and Diabetes”. This study is a Phase 3, randomized, double-blind, placebo-controlled trial. The objective of
this study is to evaluate the efficacy and safety of Alectinib in combination with standard care treatment versus placebo plus standard care treatment in patients with metastatic heart disease and diabetes.
Inclusion criteria for this study include diagnosis with metastatic heart disease or diabetes at baseline; age 18 years old or older; estimated life expectancy > 6 months; Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1; adequate organ function as defined by laboratory values within 4 weeks prior to randomization, among other criteria. Exclusion criteria include diagnosis with any other concurrent malignancy except non-melanoma skin cancer, use of any anti-cancer medication prior to randomization, major surgery within 28 days before randomization, and history of allergic reactions attributed to classes of compounds related to Alectinibⁿamouflage therapy or immunotherapy within 28 days prior to randomization among others.
This trial uses a Random Clinical Trial design which allows for an evaluation for comparative effectiveness between two treatments by randomly assigning participants into each group which allows for accurate measurement of results between both groups without bias from confounding variables that can be present when using observational studies. However due to its nonrandomized nature there are limitations present regarding external validity because the sample population may not represent reality outside the research setting due to selection bias meaning that participants recruited may differ from those found in real world scenarios thus making it difficult extrapolate findings beyond the immediate context. Additionally since this trial is double blinded there could be potential biases on behalf of researchers or participants involved who may unknowingly influence outcomes through their behaviour or expectations surrounding different treatment arms leading inaccurate results across groups compared during analysis therefore it's important that all methods employed are tightly controlled throughout each stage in order account minimize such sources error during data collection..