A pharmaceutical company is seeking participants for a clinical trial of a new drug treatment for Ulcerative colitis. They aim to enroll approximately 1000 individuals with the condition to determine if the drug is more effective than the current treatment in reducing disease activity.
What stage of the clinical trial process does this treatment fall under?
As a GP participating in research projects, you have a patient who is curious about a study testing a new antihypertensive medication. You inform them that the drug has undergone testing on several volunteers, but has not yet been approved for sale. The manufacturers are currently seeking patients to compare the effectiveness of this new drug to existing antihypertensives before it can be licensed and prescribed by all doctors.
In which phase of the drug trial are you seeking patients for recruitment?
A pharmaceutical company is developing a new drug to treat ovarian cancer. During which phase of clinical trials is the drug’s effectiveness specifically evaluated?
A researcher calculates various statistical values for a randomized controlled trial of a new drug vs an old drug that treats heart failure in elderly patients. She finds that the probability of type 1 error is 31%, the probability of type 2 error is 26%, the p-value is 0.04 and the confidence interval of 95%.
What is the power of this study for elderly patients?
A new on-the-spot test is developed to test for the presence of Alzheimer’s disease in the blood. The results of the blood test were compared with that of brain imaging in 1000 participants, and are shown below.
| Brain Imaging Positive |
Brain Imaging Negative
|
|
| Blood Test Positive | 60 | 5 |
| Blood Test Negative | 40 | 895 |
A company would like to use the blood test to identify employees that are safe to handle sensitive information. They are particularly interested in the likelihood of an employee being free of Alzheimer’s disease when they provide a negative blood test result.
What is the negative predictive value of the blood test?
A study is being conducted on 35-45 years healthy male volunteers to establish a causal link between smoking and colorectal cancer. All participants are required to log their consumption in order to stratify participants according to overall exposure. The study investigators will perform a colonoscopy on all study participants to investigate for the presence of colorectal cancer every 10 years.
What type of study is this?
Which of the following is not a recognized approach used in qualitative research?
You are working as a clinical research fellow. You design a case-control study to investigate the association between maternal diet during pregnancy and adolescent obesity.
What kind of bias is this study most susceptible to?
A group of medical students want to investigate the impact of childhood drug use on the diagnosis of dementia in later life. They propose a case-control study design. The students will randomly select a sample of patients with dementia (the cases) and a sample of patients without dementia (the controls). After this, patients will be asked to report their experience of childhood drug use. The hospital’s ethical review board is concerned with the study design. They argue that this study is particularly susceptible to recall bias and should be revised.
What is the specific concern of the review board regarding the proposed study design?
Can you rearrange the following types of research studies in their correct order according to their level of evidence, starting with the highest level on the left and ending with the lowest level on the right: systematic review of RCTs, RCTs, cohort, case-control, cross-sectional, case-series? Take your time and try to recall the hierarchy.