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