Shadowing a DoctorJuly 4, 2012
Clinical trials of new drugs are usually the last stage in the development before it is released onto the open market for over the counter or prescription use. Drug development can take many years and the rigorous testing at this stage can make or mar its success, so it is a vitally important step. The Food and Drugs Administration (FDA) in the USA and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK oversee the testing of all drugs to be used on people and they have the final say as to whether the drug can be licensed for use or not.
Some drugs which have a general beneficial use can be tested on a general population of human volunteers. These are typically chosen from a wide age range but they have a thorough health check first and are normally divided up into at least two groups, one of which is given a placebo, which is made to look exactly like the drug being tested. To make sure that no one is influenced when making observations on the effects of the drug, no one present in the testing location knows who is taking the real medication and who the fake one; the code is only broken when the trial is over. Parameters being measured will depend on the type of drug but may include blood tests, or psychometric testing.
Medical professionals administer the tests and are on hand for any adverse reactions, although these are hopefully rare at this late stage of the process. Sometimes, drugs being tested are meant for use on a specific condition and so the test group has to come from a cohort of people suffering from the condition. The drug will have been tested for general safety on animals and human volunteers at an earlier stage, but to test its efficacy there is no alternative but to involve people who are ill. This moral dilemma is carefully monitored by the FDA and the MHRA and the people taking part in the study are very carefully chosen and counselled. It can be quite overwhelming for someone suffering from a life limiting disease to find that they were in the placebo group of a test on a successful drug. These final clinical trials can take many years as results have to be set against survival times, length of remission, late onset secondary conditions and other considerations, but as the drug may well prove to have far reaching effects on sufferers from very serious conditions, time is not the main factor.
Some medical professionals choose to follow a career path in clinical trials and drug development and there is a great deal of satisfaction to be derived from being on the team that finally brings a life changing medication onto the market. The path may be slow and difficult sometimes, but if the end product is something that reduces suffering even in a small way, then it is very worthwhile.