New medicines — urgent need to assess outcomes in special groups

Jennifer H Martin and Michael D Coory
Med J Aust 2012; 196 (7): . || doi: 10.5694/mja12.10193
Published online: 16 April 2012

A few achievable strategies could improve translation of clinical research to practice

Randomised controlled trials (RCTs) provide the most internally valid method of evaluating new pharmaceuticals and, appropriately, provide the core evidence for marketing approval. However, certain patient groups (eg, older people, young people, people with comorbidities, people taking concomitant medications) are typically excluded, and RCTs are often too small and their duration too short to detect uncommon but clinically important adverse drug reactions (ADRs). Consequently, the translation of these internally valid results to the real world of everyday clinical practice is not a trivial task.1

  • 1 Princess Alexandra Hospital and University of Queensland School of Medicine, Brisbane, QLD.
  • 2 Murdoch Childrens Research Institute, Melbourne, VIC.


Competing interests:

No relevant disclosures.

  • 1. Glasziou P, Chalmers I, Altman DG, et al. Taking healthcare interventions from trial to practice. BMJ 2010; 341: c3852.
  • 2. Baker RI, Harper P, McLintock C. Avoiding adverse events with dabigatran by careful selection of eligible patients. Med J Aust 2012; 196: 431-432.
  • 3. Kelman CW, Pearson S-A, Day RO, et al. Evaluating medicines: let’s use all the evidence. Med J Aust 2007; 186: 249-252. <MJA full text>
  • 4. US Food and Drug Administration. FDA’s Sentinel Initiative. (accessed Mar 2012).
  • 5. Canadian Institutes of Health Research. Drug Safety and Effectiveness Network. (accessed Mar 2012).
  • 6. Rochon PA, Gurwitz JH. Optimising drug treatment for elderly people: the prescribing cascade. BMJ 1997; 315: 1096-1099.
  • 7. National Prescribing Service. NPS publications for health professionals. (accessed Mar 2012).
  • 8. Martin JH, Saleem M, Looke D. Therapeutic drug monitoring to adjust dosing in morbid obesity — a new use for an old methodology. Br J Clin Pharmacol 2011 Dec 1 [Epub ahead of print]. doi: 10.1111/j.1365-2125.2011.04159.x.
  • 9. US Food and Drug Administration. Significant dates in US food and drug law history. (accessed Jan 2012).


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