Clinical Studies

 

Clinical research is the longest stage in the process of developing a new medicine and has the potential to be one of the most exciting and rewarding .

In order to ensure that any new medicine are safe and effective for patients,  they are thoroughly tested.  These processes are done to understand the effectiveness of the new medicine as well as the potential side effects and compare this information to the medicine already on the market .  

Clinical trials are carried out in four phases, all of which must be completed before an application can be made to market the new medicine. 

Phase I can last anything from a few days to a few weeks.  This phase involves collecting information about the metabolism of the medicine in human subjects and will be tested on between 20 to 80 healthy volunteers or closely monitored patients.  The information is used to establish the dose and record the nature and severity of any side effects. 

Phase II  is intensive studies on patients that have the disease and the medicine is tested in terms of its effects on symptoms and signs of the disease.  Further information regarding the safety of the medicine is also tested.  In some trials the new medicine will be compared with the best currently available treatment, and in others it is compared with an inactive substance.  In both cases , neither the doctor nor the patient will know which medication they are receiving, known as the double blind manner.  This helps to record the  physical effects of the new medicine and any other effect that may occur from a patient believing they are on the new medication. 

Phase III trials only take place once the data from the previous phases have proven that the new medication is more effective and has fewer side effects than the already marketed drug available.  It is then tested on a much larger scale to determine its safety.   It is administered typically to thousands of patients sometimes over several years in order to gather data and determine the benefits and any side effects that may become apparent over long term use.  Again some patients will receive the new drug and others will be given either the existing medication or a placebo.  All information gathered is then put on a database for analysis and then submitted to the authorities for approval to market the medication.   It will then go into full manufacture and will continue to be monitored and tested for use in special groups such as children. This ‘post market’ monitoring is the late Phase or Phase IV and most drugs are monitored indefinitely by various steak holders and authorities.

Safety procedures are extremely rigorous and governed by Good Clinical Practice covering four main areas: 

  • Protection of the patients involved in the trial 
  • Ethical practice 
  • Accuracy of data obtained
  • Maintaining openness throughout the process 

In order to work in clinical trials, you must be well organised, have a methodical approach and close attention to detail.  Starting a trial involves a huge amount of planning. Physicians, clinical researches, statisticians and sometimes even patients will set out what the trial is trying to achieve. Record forms are designed to record the treatment given and any effects whether good or adverse can be recorded. Approval is then needed from both the regulatory authority and a research ethics committee and documentation can be inspected at any time during the trial or after the completion.

 

 

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