A flexible drug development process

Doctor holding up a bottle of tablets

​In order to obtain results that are clearer to interpret, clinical trials are often performed within a rigid phase framework (from Phase I to Phase IV) in groups of people that are very similar to each other but there can be scientific reasons why these are sometimes not the same as the people who are most likely to take the medication once it is on the market. New, more flexible approaches to drug development must be explored because the current model does not work well for all diseases1.  All approaches take as a given that safety and quality standards are maintained.

As we develop medicines in increasingly complicated therapeutic areas, new approaches may be more appropriate such as:

  • The identification of reliable biomarkers to identify patients who are most likely to respond well to a particular treatment. For more information see the Personalised medicines section.
  • Developing medicines for a more targeted, smaller population and launching this medicine early in development, with a comprehensive post marketing safety surveillance programme, as called for in the US NEWDIGS initiative from the Massachusetts Institute of Technology. For further information please see NEWDIGS: Catalyzing the Transformation of Healthcare Innovation (PDF, 619KB).
  • Where there is a high unmet medical need, a facility to make key treatments available to patients before they are formally launched. The UK has been making progress in this area recently. For further information visit Medicines and Healthcare products Regulatory Agency (MHRA): Earlier access to new medicines in the UK.
  • Using ‘adaptive trial designs’ where a trial is modified over time, according to modelling performed using data gathered from the trial as it progresses2

1The Lancet, Volume 375, Issue 9712, Pages 357–359, 30 January 2010 
2The future of drug development: advancing clinical trial design. Nat Rev Drug Discov. 2009 Dec;8(12):949-57. Epub 2009 Oct 9

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