Clinical Trials

5. Design Issues

Exercise 6

Decide which of these patients with high blood pressure (BP) may be reasonably excluded or included from a trial looking at the benefits of lowering blood pressure using “Lopressor”, a new drug and why?

CLICK ON EITHER “INCLUDE” OR “EXCLUDE”

1. Subject aged 50:
2. Subject with very high and very low BP:
3. Subject with poor kidney function:
4. Subject with dementia:
5. Subject with depression:
6. Subject with diabetes mellitus:

Answers:

1. Subject aged 50:
   Answer: INCLUDE
   Reason: People aged 50 are at high risk of hypertension
2. Subject with very high and very low BP:
   Answer: EXCLUDE
   Reason: Because new treatments are best avoided when the disease varies dramatically
3. Subject with poor kidney function
   Answer: EXCLUDE
   Reason: Because the patient may not excrete the drug properly
4. Subject with dementia
   Answer: EXCLUDE
   Reason: Because the patient may not be able to consent or report side effects properly
5. Subject with depression
   Answer: EXCLUDE
   Reason: Because most depressed patients are not fully compliant with medications
6. Subject with diabetes mellitus
   Answer: INCLUDE
   Reason: Because diabetes is common amongst high BP patients