Use of randomised trials to decide when to monitor response to new treatment

Katy J.L. Bell, Les M. Irwig, Jonathan C. Craig, Petra Macaskill

Research output: Contribution to journalArticlepeer-review

25 Citations (Scopus)


Is monitoring initial response to treatment always helpful in clinical management of patients? Bell and colleagues have developed a framework for deciding whether surrogate outcomes should be used to monitor initial response to treatment in chronic disease.

Monitoring entails periodic measurement to guide management1 and is widely practised in clinical medicine to inform decisions throughout the course of a disease and to provide prognostic information to patients. It is helpful to divide monitoring into phases: pretreatment, initial response, maintenance, re-establish control, and post-treatment.1

Initial response monitoring uses repeat measurement soon after a new treatment is started to check that the response is within a range that maximises the benefits while minimising the harms. Table 1 summarises different types of initial response monitoring.⇓ We have limited our discussion to the use of surrogate outcomes for monitoring initial response to treatment. Surrogate outcomes are commonly used to monitor initial response in patients with chronic conditions. This type of initial response monitoring is common in clinical practice and can result in inappropriate decisions. We looked at two scenarios to develop a rational framework for deciding whether this form of initial monitoring should be done: Should change in blood pressure be monitored after addition of a diuretic to an angiotensin II receptor blocker in adults with essential hypertension? and Should change in cholesterol be monitored after giving patients with ischaemic heart disease a statin?
Original languageEnglish
Pages (from-to)361-365
Number of pages5
JournalBMJ (International Edition)
Issue number361
Publication statusPublished - 14 Feb 2008
Externally publishedYes


  • randomised trial
  • initial response
  • hypertension
  • cholesterol
  • chronic conditions


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