• Question: How do you make sure a drug is safe for human use?

    Asked by canderson to Jack, Jon, Tom, Yalda on 18 Mar 2013. This question was also asked by gymnastjade.
    • Photo: Tom Branson

      Tom Branson answered on 18 Mar 2013:

      When a drug is developed, it has to go through a series of clinical trials. These are trials in humans to check if the drug works, but also to check if it is having any other side effects or doing anything that wasn’t expected. It usually takes years and a lot of trials before a drug is finally thought safe enough and effective enough to be used.

      These trials are known as phases:
      Phase 1 – a small group of people (50) to check mainly for safety
      Phase 2 – more people (200) to see how effective it is
      Phase 3 – a large number of people (2,000) to confirm and check side-effects and compare with current drugs
      Phase 4 -they decide on the risks and benefits and the optimal use

      A drug might fail at any phase and then won’t be used, but if it passes everything then it will be used to help people.

    • Photo: Jon Marles-Wright

      Jon Marles-Wright answered on 18 Mar 2013:

      Tom’s explanation is as good as any as I could give. I’ll add that it is hugely expensive ~$1 billion and most drugs fail to reach market.

    • Photo: Jack Heal

      Jack Heal answered on 18 Mar 2013:

      Lots and lots of testing! After testing in the lab (e.g. how easy is it to make? Is it really pure? how well does the drug bind to the thing it’s trying to stop? Does it stay in tact in the conditions which are found in the body?) and animal testing, the drug can be tested on humans. And like Tom said this is done in stages, with more people taking part each time. It’s really difficult to get enough suitable people to take part in trials and they can be expensive and take a long time.
      All in all, it may take 12-15 years for a typical drug to get from the lab to the shops/chemists!

    • Photo: anon

      anon answered on 18 Mar 2013:

      Ton is going to steal all the votes here as he’s got it covered! Have a look here too – http://ias.im/102.607 which tells you a bit about how people try to work out if a drug is any good.

    • Photo: Yalda Javadi

      Yalda Javadi answered on 19 Mar 2013:

      It’s a long old process… I’ll break it down for ya!

      1- Testing on animals

      2- A panel of scientist and non-scientists decide if it should be tested on humans – and which type of humans can participate.

      3- Phase 1 (as Tom’s described)

      4- Phase 2

      5- Phase 3

      6- Some more people meet and go through the results

      7- Then…. and only then can the application begin for making it a new drug.

      This is a lengthy process that takes years…and costs lots too.

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